ATTACHMENT A. Informed Consent Forms 7.26.18 CLEAN

ATTACHMENT A:

MULTI SITE IMPLEMENTATION EVALUATION OF TRIBAL HOME VISITING (MUSE)

INFORMED CONSENT FORMS

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

Table of Contents

CONTINUING CAREGIVER OVER 18 QUANTITAVE CONSENT 1

CONTINUING CAREGIVER UNDER 18 QUANTITAVE CONSENT 6

NEW CAREGIVER OVER 18 QUANTITAVE CONSENT 11

NEW CAREGIVER UNDER 18 QUANTITAVE CONSENT 16

HOME VISITOR QUANTITAVE CONSENT 21

PROFESSIONAL (NON HOME VISITOR) QUANTITAVE CONSENT 26

PROGRAM IMPLEMENTATION SURVEY CONSENT FORM 31

CAREGIVER OVER 18 QUALITATIVE CONSENT 36

PROFESSIONAL OVER 18 QUALTITAVE CONSENT 41

CONTINUING CAREGIVER OVER 18 QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting caregiver

18 years or older

Enrolled in home visiting services BEFORE the MUSE study started (before XX-XX-2018)

You and your child are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Someone from [HOME VISITING PROGRAM] will explain this study to you and answer your questions about it. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the children and families in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you and your child are in the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you, your experiences as a parent, and your child’s development.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to:

1. Take a 5-minute survey after a few of your home visits.

2. Allow [HOME VISITING PROGRAM] to share some information about you with the MUSE study. For example, they will share information about the services they provide to you. They will also share your responses to questions they ask you about financial needs [substance use, and mental health].

We are also going to interview a few people about their experiences in home visiting. A MUSE researcher may contact you to ask if you would be willing to be interviewed.

What happens if I agree to let my child join this study?

If you agree to let your child join the study, you will allow [HOME VISITING PROGRAM] to share the following information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire scores.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on how long you are enrolled in [HOME VISITING PROGRAM]. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about your experiences with [HOME VISITING PROGRAM] and with your home visitor. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you from the [HOME VISITING PROGRAM] or on the surveys will not be connected to your name. [HOME VISITING PROGRAM] will assign you an ID number to keep your information private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not be paid for being in the study. It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive home visiting services.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to survey questions your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

Consent to use my child’s data in the MUSE study

I agree to allow [HOME VISITING PROGRAM] to share my child’s birth month and year, sex, and Ages and Stages Questionnaire scores with the MUSE study. (Check one box)

• Yes

• No

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

CONTINUING CAREGIVER UNDER 18 QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting caregiver

Under 18 years old

Enrolled in home visiting services BEFORE the MUSE study started (before XX-XX-2018)

You and your child are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Someone from [HOME VISITING PROGRAM] will explain this study to you and answer your questions about it. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the children and families in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you and your child are in the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you, your experiences as a parent, and your child’s development.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to:

3. Take a 5-minute survey after a few of your home visits.

4. Allow [HOME VISITING PROGRAM] to share some information about you with the MUSE study. For example, they will share information about the services they provide to you. They will also share your responses to questions they ask you about financial needs[, substance use, and mental health].

We are also going to interview a few people about their experiences in home visiting. A MUSE researcher may contact you to ask if you would be willing to be interviewed.

What happens if I agree to let my child join this study?

If you agree to let your child join the study, you will allow [HOME VISITING PROGRAM] to share the following information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire scores.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on how long you are enrolled in [HOME VISITING PROGRAM]. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about your experiences with [HOME VISITING PROGRAM] and with your home visitor. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you from the [HOME VISITING PROGRAM] or on the surveys will not be connected to your name. [HOME VISITING PROGRAM] will assign you an ID number to keep your information private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not be paid for being in the study. It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive home visiting services.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to survey questions about your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Assent to participate in the MUSE study

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

Consent to use my child’s data in the MUSE study

I agree to allow [HOME VISITING PROGRAM] to share my child’s birth month and year, sex, and Ages and Stages Questionnaire scores with the MUSE study. (Check one box)

• Yes

• No

Parental consent for participation

This study has been explained to me and my child, who is a teen parent participating in the [HOME VISITING PROGRAM]. I give my consent for my child to participate in the MUSE study.

• Yes

• No

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

NEW CAREGIVER OVER 18 QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting caregiver

18 years or older

Enrolled in home visiting services AFTER the MUSE study started (after XX-XX-2018)

You and your child are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Someone from [HOME VISITING PROGRAM] will explain this study to you and answer your questions about it. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the children and families in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you and your child are in the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you, your experiences as a parent, and your child’s development.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to:

5. Take up to 3 surveys about you and your experiences with [HOME VISITING PROGRAM]. The surveys will take approximately 15-30 minutes to complete.

6. Take a 5-minute survey after a few of your home visits.

7. Allow [HOME VISITING PROGRAM] to share some information about you with the MUSE study. For example, they will share information about the services they provide to you. They will also share your responses to questions they ask you about financial needs[, substance use, and mental health].

We are also going to interview a few people about their experiences in home visiting. A MUSE researcher will contact you to ask if you would be willing to be interviewed.

What happens if I agree to let my child join this study?

If you agree to let your child join the study, you will allow [HOME VISITING PROGRAM] to share the following information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire scores.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you enroll in [HOME VISITING PROGRAM]. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about your experiences with [HOME VISITING PROGRAM] and as a parent. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you from the [HOME VISITING PROGRAM] or on the surveys will not be connected to your name. [HOME VISITING PROGRAM] will assign you an ID number to keep your information private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

If you participate in the study, you will get:

• A $10 gift card for taking a survey now.

• A $15 gift card each time you take another survey. You will be asked to take up to 2 more surveys.

It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive home visiting services.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to survey questions about you, your family, and your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

Consent to use my child’s data in the MUSE study

I agree to allow [HOME VISITING PROGRAM] to share my child’s birth month and year, sex, and Ages and Stages Questionnaire scores with the MUSE study. (Check one box)

• Yes

• No

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

NEW CAREGIVER UNDER 18 QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting caregiver

Under 18 years old

Enrolled in home visiting services AFTER the MUSE study started (after XX-XX-2018)

You and your child are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Someone from [HOME VISITING PROGRAM] will explain this study to you and answer your questions about it. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the children and families in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you and your child are in the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you, your experiences as a parent, and your child’s development.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to:

8. Take up to 3 surveys about you and your experiences with [HOME VISITING PROGRAM]. The surveys will take approximately 15-30 minutes to complete.

9. Take a 5-minute survey after a few of your home visits.

10. Allow [HOME VISITING PROGRAM] to share some information about you with the MUSE study. For example, they will share information about the services they provide to you. They will also share your responses to questions they ask you about financial needs[, substance use, and mental health].

We are also going to interview a few people about their experiences in home visiting. A MUSE researcher will contact you to ask if you would be willing to be interviewed.

What happens if I agree to let my child join this study?

If you agree to let your child join the study, you will allow [HOME VISITING PROGRAM] to share the following information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire scores.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you enroll in [HOME VISITING PROGRAM]. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about your experiences with [HOME VISITING PROGRAM] and as a parent. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you from the [HOME VISITING PROGRAM] or on the surveys will not be connected to your name. [HOME VISITING PROGRAM] will assign you an ID number to keep your information private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

If you participate in the study, you will get:

• A $10 gift card for taking a survey now.

• A $15 gift card each time you take another survey. You will be asked to take up to 2 more surveys.

It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive home visiting services.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to survey questions about you, your family, and your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Assent to participate in the MUSE study

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

Consent to use my child’s data in the MUSE study

I agree to allow [HOME VISITING PROGRAM] to share my child’s birth month and year, sex, and Ages and Stages Questionnaire scores with the MUSE study. (Check one box)

• Yes

• No

Parental consent for participation

This study has been explained to me and my child, who is a teen parent participating in the [HOME VISITING PROGRAM]. I give my consent for my child to participate in the MUSE study.

• Yes

• No

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

HOME VISITOR QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting professional (Home visitor)

You are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. If you have questions, you may contact a member of the MUSE study team and they will answer your questions. Their contact information is at the end of this form. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you are a home visitor with the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you and your experiences as a home visitor.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to take a survey about you and your experiences as a home visitor with [HOME VISITING PROGRAM]. The survey will take approximately 70 minutes to complete.

We are also going to interview a few home visitors about their experiences. A MUSE researcher may contact you to ask if you would be willing to be interviewed.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about your experiences with [HOME VISITING PROGRAM] and as a home visitor. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you on the survey will not be connected to your name. We will assign you an ID number to keep your information private. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not receive anything for being in the study. It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it will not affect your job as a home visitor with [HOME VISITING PROGRAM]. If you decide to stop being in the study later, it will not affect your job as a home visitor with [HOME VISITING PROGRAM]. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to be in the study or not. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to stop being in the study later.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Name and Demographic Information (age, sex, ethnicity)

• Your staff role with the home visiting program

• Your answers to survey questions about you and your experience with the home visiting program

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. If you have questions now or later, you may call Dr. Whitesell at 303-724-1456.

You may have questions about your rights as a person in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I can save or print a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

PROFESSIONAL (NON HOME VISITOR) QUANTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting professional (Non-Home visitor)

18 years or older

You are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. If you have questions, you may contact a member of the MUSE study team and they will answer your questions. Their contact information is at the end of this form. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you work with the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you and your work experiences.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to take a survey about you and your experiences working with [HOME VISITING PROGRAM]. The survey will take approximately [30/45/60] minutes to complete.

We are also going to interview a few people about their experiences. A MUSE researcher will contact you to ask if you would be willing to be interviewed.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about you and your experiences with [HOME VISITING PROGRAM]. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. The information we will collect about you on the survey will not be connected to your name. We will assign you an ID number to keep your information private. We do this to protect your sensitive information.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not be receive anything for being in the study. It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it will not affect your job with [HOME VISITING PROGRAM]. If you decide to stop being in the study later, it will not affect your job with [HOME VISITING PROGRAM]. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to be in the study or not. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to stop being in the study later.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Name and Demographic Information (age, sex, ethnicity)

• Your staff role with the home visiting program

• Your answers to survey questions about you and your experience with the home visiting program

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. If you have questions now or later, you may call Dr. Whitesell at 303-724-1456.

You may have questions about your rights as a person in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I can save or print a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

PROGRAM IMPLEMENTATION SURVEY CONSENT FORM

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 1

Informed consent for: Home visiting program coordinator/manager and program director

18 years or older

You are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. If you have questions, you may contact a member of the MUSE study team and they will answer your questions. Their contact information is at the end of this form. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you work with the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you and your work experiences.

17 tribal home visiting programs are involved in the MUSE study.

Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,489 people will be included.

What happens if I join this study?

If you join the study, you will be asked to take a survey about the [HOME VISITING PROGRAM] and its operations. The survey will take approximately 15 minutes to complete.

We are also going to interview a few people about their experiences. A MUSE researcher will contact you to ask if you would be willing to be interviewed.

How long will the MUSE study last?

The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.

What are the possible discomforts or risks?

The survey asks about [HOME VISITING PROGRAM] operations. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. We will use your name to link your survey responses to other information you provide for the study. MUSE study staff trained in protecting privacy will have access to your survey responses, which will be linked to your name. Once we begin analysis and reporting, we will remove your name from your survey responses and only use an ID number to identify your data. We do this to protect your sensitive information. We will never use your name in any report.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not receive anything for being in the study. It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it will not affect your job with [HOME VISITING PROGRAM]. If you decide to stop being in the study later, it will not affect your job with [HOME VISITING PROGRAM]. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to be in the study or not. The MUSE study team will never tell anyone at [HOME VISITING PROGRAM] if you choose to stop being in the study later.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise. If you choose to complete this survey with another manager at [HOME VISITING PROGRAM], they will see the answers you enter together. However, they will not have a link to access the survey on their own.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Name and Demographic Information (age, sex, ethnicity)

• Your staff role with the home visiting program

• Your answers to survey questions about your home visiting program

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. If you have questions now or later, you may call Dr. Whitesell at 303-724-1456.

You may have questions about your rights as a person in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I can save or print a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

CAREGIVER OVER 18 QUALITATIVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting caregiver

18 years or older

You are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Someone from [HOME VISITING PROGRAM] will explain this study to you and answer your questions about it. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We also want to learn about the children and families in these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you and your child are in the [HOME VISITING PROGRAM]. We want to know about your experiences with [HOME VISITING PROGRAM]. We also want to know about you, your experiences as a parent, and your child’s development.

17 tribal home visiting programs are involved in the MUSE study.

We will ask families receiving home visiting services and program staff to be in the study. Up to 1,489 people will be included. Within this larger MUSE study, we will also interview up to 60 people who are receiving home visiting services.

What happens if I join this study?

You have been taking part in other parts of the MUSE study. We are now asking you to be interviewed about your experiences with home visiting.

If you agree to be interviewed, you will:

11. Talk with someone from the MUSE team about you, your family and your experience with [HOME VISITING PROGRAM].

12. You will be interviewed in a private office. Only you and the interviewer will be able to hear your conversation.

13. At the time of the interview, you will be asked to let us record the interview (audio only). If you agree, we will later transcribe the recording and remove any names you mention.

14. MUSE study team members will then share some of what they learn from these interviews in presentations, or written reports, or articles in professional journals. Anything shared from the interviews will be written or presented in a way that does not identify you, your family, [HOME VISITING PROGRAM] or your community.

How long will the MUSE study last?

The full MUSE study will last for about 2 years. The interview you are being asked to participate in will happen one time and will take about one hour.

What are the possible discomforts or risks?

The interview will ask about your experiences with [HOME VISITING PROGRAM] and as a parent. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. We will assign you an ID number and use this ID instead of your name on your interview transcript to keep your information private.

There are some times when we cannot keep your information private because we want to make sure people are safe. If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the appropriate authority, as per tribal and state legal codes. If you tell us that you are going to physically hurt yourself or someone else, we have to report that to the police.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

If you participate in the study, you will get:

• A $40 gift card for participating in the interview

It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive home visiting services.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

If you consent to participate in the MUSE interview, your conversation with the MUSE study team member will be audio-recorded on a digital recording device. We will protect the audio-recordings by:

• Using only password protected portable audio-recording devices;

• Transferring and storing audio-recordings and interview transcripts using secure data platforms accessible to MUSE study team members only;

• De-identifying transcripts during transcription process;

• Erasing audio-files stored on portable devices directly after successful transfer to secure data platform is confirmed;

Audio-recordings will be erased after transcript is verified and interview transcripts will be kept for 5 years after the MUSE study is complete and then erased.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Name and Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to interview questions about you, your family, and your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights as a participant in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.

PROFESSIONAL OVER 18 QUALTITAVE CONSENT

Study Title: Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)

Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.

COMIRB No: 18-0109

Version Date: July 25, 2018 Version #: 2

Informed consent for: Home visiting professional

You are being asked to be in a research study. This form provides you with information about the study. [HOME VISITING PROGRAM] is participating in this study with other tribal home visiting programs across the country. Please read the information below and ask questions about anything you don’t understand before deciding whether or not you want to participate in this study.

Why is this study being done?

We are doing this study to learn about tribal home visiting programs. We want to learn about the children and families receiving services as well as the experiences of leadership and staff who work on these programs. This study may help programs by identifying what is working well and where services can be improved. It may also help programs to better understand the families they are serving.

We are asking you to be in this research study because you are currently employed by [HOME VISITING PROGRAM]. We want to know about your experience working on [HOME VISITING PROGRAM].

17 tribal home visiting programs are involved in the MUSE study.

We will ask families receiving home visiting services and program staff to be in the study. Up to 1,489 people will be included. Within this larger MUSE study, we will also interview up to 100 program staff.

What happens if I join this study?

You may have been taking part in other parts of the MUSE study. We are now asking you to be interviewed about your experiences with home visiting.

If you agree to be interviewed, you will:

15. Talk with someone from the MUSE team about you, the agency or organization where you work and your experience with [HOME VISITING PROGRAM].

16. You will be interviewed in a private office. Only you and the interviewer will be able to hear your conversation.

17. At the time of the interview, you will be asked to let us record the interview (audio only). If you agree, we will later transcribe the recording and remove any names you mention.

18. MUSE study team members will then share some of what they learn from these interviews in presentations, or written reports, or articles in professional journals. Anything shared from the interviews will be written or presented in a way that does not identify you, anyone you discuss in the interview, [HOME VISITING PROGRAM] or your community.

How long will the MUSE study last?

The full MUSE study will last for about 2 years. The interview you are being asked to participate in will happen one time and will take between one and two hours.

What are the possible discomforts or risks?

The interview asks about your experiences at work with [HOME VISITING PROGRAM]. Some of these questions may make you feel uncomfortable.

There is a small risk that your personal information will accidentally become known. We take steps to make this unlikely. We will assign you an ID number and use this ID instead of your name on your interview transcript to keep your information private.

There are sometimes when we cannot keep your information private because we want to make sure people are safe. If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the appropriate authority, as per tribal and state legal codes. If you tell us that you are going to physically hurt yourself or someone else, we have to report that to the police.

What are the possible benefits of the study?

This study is being done to learn more about home visiting services in Native communities. You will not benefit directly from being in this study.

Who is paying for this study?

This research is being paid for by the Administration for Children and Families Office of Planning, Research, and Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration for Children and Families is one of the funders of [HOME VISITING PROGRAM].

Will I receive anything for being in the study? Will participating in the study cost me anything?

You will not be paid for being in the study.

It will not cost you anything to be in the study.

Is my participation voluntary?

Taking part in this study is voluntary. You have the right to choose not to take part in this study.

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you will not be penalized.

Who will see my research information?

The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you. Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it.

The institutions involved in this study include: University of Colorado Denver

We cannot do this study without your permission to see, use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study.

We will see, use and disclose your information only as described in this form and in our Notice of Privacy Practices; however, people outside the University of Colorado Denver and its affiliate hospitals may not be covered by this promise.

We will do everything we can to keep your records a secret. It cannot be guaranteed.

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by writing to the study’s Primary Investigator, at the name and address listed below. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study.

Dr. Nancy Rumbaugh Whitesell

University of Colorado Anschutz Medical Campus

Mail Stop F800

Nighthorse Campbell Native Health Building

13055 E. 17th Place, Room 333

Aurora, Colorado, 80045

Both the research records that identify you and the consent form signed by you may be looked at by others who have a legal right to see that information.

• Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.

• People at the Colorado Multiple Institutional Review Board (COMIRB)

• The study director and the rest of the study team at the University of Colorado and James Bell Associates, Inc.

• The Administration for Children and Families, who is the agency paying for this research study.

• Officials at the institution where the research is being conducted and officials at other institutions involved in this study who are in charge of making sure that we follow all of the rules for research

We might talk about this research study at meetings. We might also print the results of this research study in relevant journals. But we will always keep the names of the research subjects, like you, private.

If you consent to participate in the MUSE interview, your conversation with the MUSE study team member will be audio-recorded on a digital recording device. We will protect the audio-recordings by:

• Using only password protected portable audio-recording devices;

• Transferring and storing audio-recordings and interview transcripts using secure data platforms accessible to MUSE study team members only;

• De-identifying transcripts during transcription process;

• Erasing audio-files stored on portable devices directly after successful transfer to secure data platform is confirmed;

Audio-recordings will be erased after transcript is verified and interview transcripts will be kept for 5 years after the MUSE study is complete and then erased.

You have the right to request access to your personal health information from the Investigator.

Information about you that will be seen, collected, used and disclosed in this study:

• Name and Demographic Information (age, sex, ethnicity)

• Your record of participation in the home visiting program

• Your answers to interview questions about you, your family, and your experience with home visiting

What happens to Data that are collected in this study?

Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes and cures of disease. The data collected from you during this study are important to this study and to future research. If you join this study:

• The data are given by you to the investigators for this research and so no longer belong to you.

• Both the investigators and any sponsor of this research may study your data collected from you.

• If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB approval.

• Any product or idea created by the researchers working on this study will not belong to you.

• There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or idea.

Who do I call if I have questions?

Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If you have questions later, you may call Dr. Whitesell at 303-724-1456. You may also ask your [home visitor/parent educator/other] any questions you have or call [HOME VISITING PROGRAM] at xxx-xxx-xxxx. When you call, let them know you have a question about the MUSE research study.

You may have questions about your rights as a participant in this study. You can call Dr. Whitesell with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [or the LOCAL IRB NAME at xxx-xxx-xxxx].

Consent to be in this study and use my data

I have read this form about the study or it was read to me. I understand the possible risks and benefits of this study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.

Do you want to be in the study at this time? (Check one box)

• Yes

• No

I explained the MUSE study to the participant and answered questions. I believe the participant understands what is expected during this study.

Consent form explained by: ____________________________________ Date________

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB number for the described information collection is 0970-0XXX and the expiration date is XX/XX/XXXX.