NonSub Change Memo - HBCC PE Updates from Pretesting and IRB review

Memorandum

To: Kelsi Feltz

Office of Information and Regulatory Affairs (OIRA)

Office of Management and Budget (OMB)

From: Ann Rivera

Office of Planning, Research and Evaluation (OPRE)

Administration for Children and Families (ACF)

Date: August 22, 2023

Subject: Nonsubstantive Change Request – Home-Based Child Care Practices and Experiences Study [OMB # 0970-0612]

This memo requests approval of nonsubstantive changes to the approved information collection, Home-Based Child Care Practices and Experiences Study (HBCC PPE) [OMB Information Collection Request 0970-0612]. Specifically, we request approval of updates to the instruments and recruitment materials.

Background

The goal of the HBCC PPE study is to examine the experiences, strengths, resources, and strategies used by home-based child care providers to serve and support equitable outcomes for children and families. The study is designed to explore the experiences of family, friend, and neighbor providers (i.e., home-based child care providers who are legally exempt from state licensing or other regulations that apply to non-custodial care of children in the provider’s own home.) The study uses semi-ethnographic, open-ended methods (including semi-structured interviews, and photo and audio journals) to generate rich information about the experiences of study respondents.

The study team pretested the study protocol, methods, and materials with a small group of Spanish-speaking providers (less than 10) during the public comment period and identified several potential changes to the language and materials that would help to reduce burden or improve understanding among respondents. In addition, the project’s Internal Review Board (IRB) completed its review of the study application and requested changes to consent procedures and language to improve informed consent among potential study participants.

Overview of Requested Changes
In response to findings from pretesting with Spanish-speaking providers and to edits identified by the project’s IRB, the requested changes fall into four categories:

1. Updates to consent statements and forms (English and Spanish)

2. Slight wording changes to instrument introduction text and questions (English and Spanish)

3. Minor revisions to participant recruitment materials (English)

4. Spanish versions of all study appendices

The proposed modifications to instruments and recruitment materials are summarized below in more detail. We are not proposing any adjustments to the data collection approach or approved time period. These changes do not affect burden estimates or meaningfully alter the instrument content for respondents.

We request a response as soon as possible so that we can begin data collection for this study.

1. Updates to consent statements and forms

The study team’s IRB requested changes to the consent statements included in seven instruments.

Table 1. Updates to consent statements and forms

Change	Updated Materials	Description
Add an explicit question to confirm that respondents agree to participate in the data collection activity	Instrument 1. Provider Screener Instrument 3. Provider logistics call Instrument 9. Provider feedback back focus group Appendix D. Consent statements and interview contact forms.	Added: “Do you agree to participate in this call?” to Instruments 1, 3, and 9. Provider Screener, “Is it ok to proceed with this call?” to Instrument 3. Provider logistics calls, and “Does everyone agree to participate in this group?” to Instrument 9. Provider feedback focus group. We incorporated these changes into Appendix D. Consent statements and interview contact forms.
Acknowledge minimal psychological risk in the consent statement, as well as noting there are no other risks or benefits	Instrument 2. Provider Interview #1 Instrument 6. Provider interview #2 Instrument 7. Family member interview Appendix D. Consent statements and interview contact forms.	Added bolded text: “There is a small chance that responding to some of our questions could bring up topics that are upsetting to you. You can choose to not answer a question for this, or any other reason, if you wish. We can also pause or stop an interview at any point. There are no other risks, or benefits, to participation. We incorporated these changes into Appendix D. Consent statements and interview contact forms.
Add a statement that there are no risks or benefits to respondents	Instrument 6. Provider interview #2 Instrument 8. Community member interview Instrument 9. Provider feedback focus group Appendix D. Consent statements and interview contact forms.	Added: “There are no direct benefits or risks to participation.” We incorporated these changes into Appendix D. Consent statements and interview contact forms.
Add additional information about plans to archive data	Instrument 2. Provider Interview #1 Instrument 6. Provider interview #2 Instrument 7. Family member interview Instrument 8. Community member interview Appendix D. Consent statements and interview contact forms.	Added: “In the future, responses from this study (with nothing identifying participants) might be securely shared with qualified individuals for additional learning purposes to better understand the strengths of home-based child care.” We incorporated these changes into Appendix D. Consent statements and interview contact forms.
Instruct focus group participants not to use names of others	Instrument 9. Provider feedback focus group	Added bolded text: “Privacy also depends on you. We ask that none of you share what you hear from other providers with others outside the group. We also ask that you do not use the names of individual children or other adults during this conversation.”
Include information that is included in Instrument 2. Provider interview #1 consent statement	Instrument 6. Provider interview #2	Added bolded text: We will keep your participation private. We will only use your responses for research purposes and in ways that will not reveal who you are. We will not share your responses with others who participate in the study, including family members of the children you care for and the person in the community who supports you. There are a few exceptions to this; for example, if you indicate that you are planning to harm yourself or others, we may be required by law to share that with the appropriate authorities. We will produce reports that will describe the experiences and viewpoints expressed by those we interview. However, in some previous studies, people have agreed to let researchers share additional details of their experiences and identity because they want to share this with others who take care of children and people interested in supporting child care. In the future, we might ask if you are interested in letting us share your details and identity in our reports. We will only share what you feel comfortable sharing and explicitly agree to share.
Add information that is included in other instrument consent statements	Instrument 9. Provider feedback focus group	Made the consent statement consistent with other instruments by adding: “We have a Certificate of Confidentiality from the National Institutes of Health. The Certificate helps us protect your privacy by limiting when the study team can give out information that identifies you, but there are a few exceptions. For example, if you indicate that you are planning to harm yourself or others, we may be required by law to share that with the appropriate authorities. The U.S. Department of Health and Human Services (HHS) may ask for data for an audit or evaluation. If they do, we will need to provide it. However, only HHS staff involved in the review will see it.”
Add child assent procedures for children old enough to assent, including signing an assent form if 10 years or older, for the children to appear in photo journal entries	Instrument 2. Provider interview #1 Appendix C. Instructions for providers to use study tools. Appendix D. Consent statements and interview contact forms Supporting Statement A (SSA), Section A.11	Added a child assent form to Appendix D. Consent statements and interview contact forms and instructions about the child assent forms to Appendix C. Instructions for providers to use study tools. Added bolded text to Instrument to reference the child assent procedures: One important note, about the photos: we cannot include any photos that have the children you care for in them until their parent or guardian has given written permission that this is okay and, if their parent or guardian gives permission, until children have also said this is okay (if they are old enough to understand). We will send you a flyer and a form and ask you to give them to all of the families of the children in your care. These materials explain the photos and ask them to indicate whether they give permission for their child to be in photos or not, and to sign the form. There is also a form that any child age 10 or older will need to sign. Added description of the child assent process for the photo journals to the SSA.
Add child assent procedures for children old enough to assent, including signing an assent form if 10 years or older, for the children to appear in photo journal entries	Instrument 3. Provider logistics call Appendix C. Instructions for providers to use study tools. Appendix D. Consent statements and interview contact forms	Added a child assent form to Appendix D. Consent statements and interview contact forms and instructions about the child assent forms to Appendix C. Instructions for providers to use study tools. Added bolded text to Instrument to reference or explain the child assent procedures to providers: Second, we want to talk about what we’d like you to do to ask permission from family members for their children to possibly appear in a photo, permission from the children themselves in some cases, what to do to ask permission from family and community members to be contacted for an interview, and how to send that information back to us. Now please look for the 10 copies each of the “Family Consent Form for HBCC P&E Study Photos” (GREEN PAPER), “Child Assent Form for HBCC P&E Study Photos” (GREEN PAPER), “Family Contact Form for HBCC P&E Study Interviews,” and a study flyer for family members (GREEN PAPER). Family and Community Member Permissions Overview. Before we take out the phone, I want to describe the steps we will ask you to take to make sure the parents of the children in your care are aware of the study and agree to having you take photos while their children are in your care. We will also talk about making sure the children are ok with being in photos. Let’s talk about the children and family members first. In addition to having permission from parents, please make sure that any child old enough to understand what you are doing agrees to be included in any photos you take. You can let the children know you might take some pictures for an activity you are participating in, that their parents said it was ok, and ask if they are ok with being in photos. You can use your judgment on when a child is too young to understand, and do not need to discuss with them. (If they care for any school-age children) For older children who are in school, you can add that it’s a research study to learn more about the provider’s experiences, and that the photos will only be used for research. Any child 10 years or older who might appear in a photo, including your own children, also needs to read and sign a copy of the “Child Assent Form for HBCC P&E Study Photos” from the FedEx package. (All providers) Please do not take any photos of children who do not want to be photographed, even if a parent has given permission. If a parent does not give permission, then children cannot be photographed even if they would have agreed. In other words, both the parent and child (if old enough) have to give permission. Do you have any questions for me about getting permission and consent from parents or children? For the photos, we are trying to focus on activities you do with children and the spaces where you do those activities, not the individual children you are caring for. Because of that, photos do not need to include children. However, it is okay if a child appears in a photo as long as the child is okay with being photographed (including signing the child assent form if they are 10 years or older) and the child’s parent signed the family consent form and marked that it would be okay for their child to appear in photos. If children might appear in photos, you can tell the children that they should keep doing whatever they’re doing when you take the photo and these aren’t photos they should pose for. Do you have any questions? The first thing you’ll want to do is to use the family consent form to get permission from families to take photos of their children and agreement from children to be in photos (including the child assent form for any children 10 years or older); and then submit the forms on the EthOS app. And one more reminder to please hand out the flyers and forms we talked about to family and community members, and once you get the forms back from families (and children if old enough) and get permission from community members, to upload photos of those forms through EthOS. Deleted: We understand children might ask why you are taking photos. We recommend ask that you let the children know you might take some pictures for an activity you are participating in, that their parents said it was ok, and that they should keep doing whatever they’re doing when you take the photo and these aren’t photos they should pose for. (If they care for any school-age children) For older children who are in school, you could probably to add that it’s a research study to learn more about the provider’s experiences, and that the photos will only be used for research.
Provide two copies of consent forms so participants can retain signed copies	Instrument 3. Provider logistics call	Added bolded text to explain this to the provider (since the providers will distribute the forms to families): For the family consent form, if a parent says that they do not want you to take any photos of their child, please follow their request. Please do this before you start taking photos. You know your families best, so for some parents it might work well for you to explain the study and how you are contributing to it to them at drop off and pick up. Then you could ask them to sign the forms and leave them with you. Please give them two copies so they can keep one as a record.
Instruct providers not to include other adults in photos and not to mention anyone by name in audio recordings	Instrument 3. Provider logistics call Appendix C. Instructions for providers to use study tools.	Added bolded text: A few important notes about the photo and audio journals. We’ll start with a couple notes related to the photo. First, it’s fine to take photos in your home or a shared or public space, such as a sidewalk or library. However, please do not take any photos in someone else’s home, such as the home of a child you care for (If the provider lives with any noncustodial children they care for, clarify that is okay because it’s their home). Second, we also don’t want you to take photos of any adults, even if they are involved in caring for the children or are members of your family. For the audio journals, we ask that you do not say the names of other adults, including the names of your family members or children’s family members and the names of other adults who help you care for children. We incorporated these changes into Appendix C. Instructions for providers to use study tools.

2. Slight wording changes to instrument introduction text and questions

The study team made slight wording changes to introduction text and questions in three instruments in response to: (1) feedback from their IRB and (2) input from pretesting with a small group of providers who speak Spanish on Spanish versions of instruments and materials. Some of the input from the providers was relevant to the English versions of the instruments.

Table 2. Summary of wording changes

Change	Instrument(s)	Description
Added to the introduction about the study a sentence acknowledging there might be different labels they’ve been called and a couple sentences emphasizing that we want to learn from the providers	Instrument 1. Provider screener Instrument 2. Provider interview #1	Added: You may have been called a child care provider, a caregiver, a babysitter, or something else. (Moving forward, use the term they respond to.) You know the most about your own experiences, and we want to learn from you. Our goal in this study is to listen to you and improve our understanding of how people like you care for children at home.
Edited question S9a to use less formal language	Instrument 1. Provider screener	Edits to question include deletions (shown with strike through) and additions (shown in bold). S9a. Before you started looking after these children, did you have a prior relationship with know any of their families personally? If yes: For How many of these children did you have a prior relationship with know personally before you started looking after them? What is your personal relationship to those children?
Revised questions 1 and 3 to ask about children generally rather than by individual child	Instrument 2. Provider interview #1	Deleted table 1 and rephrased questions to generally ask about children in care. For example, instead of “What is [CHILD’S NAME] gender?”, revised to “What are the genders of the children you care for?” Deleted table 2 and rephrased questions to generally ask about the providers’ own children.
Revised question 13 to ask provider about their identity first, instead of trying to define it based on information collected in the screener, but using a probe based on information gathered in Instrument 1. Provider screener	Instrument 2. Provider interview #1	Edits to question include deletions (shown with strike through) and additions (shown in bold). In our first phone call, you told us that you identify as [USE PROVIDER’S WORDS FROM SCREENER]. Tell me more about this about your identity and why how it is important to you and your work caring for children. PROBE IF NEEDED: In our first phone call, you told us that you identify as [USE PROVIDER’S WORDS FROM SCREENER], how is this important to you and your work caring for children?
Moved optional probes from week 2 to week 3 and moved optional prompts from week 3 to week 2. Language of the probes remained the same.	Instrument 5. Provider audio journals	Moved the following week 3 optional prompts for audio journals to week 2: Tell us about a time this week when you responded to a child’s interests (for example, reading a book together, playing a game).  What were you doing?  How did you use your own knowledge about this child and their cultural and family background to interact with them?  How do you think this child felt? Tell us about an interaction that you had this week with the children where you were helping them learn about reading or numbers.  What did this look like?  What do you hope children learned from this interaction? Tell us about a time this week when you encouraged a child to be physically active or you did a physical activity with a child.  What were you doing?  How did you feel during this interaction with children?  How do you think children felt? Moved the following week 2 optional prompts for audio journals to week 3: Tell us about a time this week when you helped children of different ages do an activity or play together.  What did the children get out of the activity or experience?  What do you think children learned from each other? Tell us about a time this week when you had to address a child’s behavior that you found challenging (for example, infants who sleep very lightly or spit up a lot, toddlers who bite, preschoolers who hit, school-age children who struggle with their homework)?  What did you do?  How did the child react?  In what ways did you reach out to the child’s family?  In what ways did you draw on your own cultural knowledge to support this child?  How did you feel about this interaction? Tell us about a time this week when you helped children understand and appreciate their differences or when you helped children recognize their bias towards others who are different from them.  How do you think your own experiences with racism or other inequities or inequalities influence these interactions with children?
Revised question 2 to keep identity open-ended, instead of trying to define it based on information gathered in Instrument 2. Provider Interview #1	Instrument 6. Provider interview #2	Edits to question include deletions (shown with strike through) and additions (shown in bold). Please tell me more about how your own cultural identity and values influence the way you take care of and support children. For example, how does your identity as a [how they identify in interview #1] influence your care of children? PROBE: How do you draw on your own identity and experiences as a [use self identifier e.g., Black woman/Latina woman/Chinese-American woman; a single mother] in your care of children? Please share some examples.

3. Minor revisions to participant recruitment materials

The study team made slight wording changes to two materials included in Appendix A. Participant recruitment materials in response to feedback from providers on the Spanish versions of the materials.

• Revised Provider Frequently Asked Questions to add different labels provider may be called (deletions shown with strike through and additions shown in bold text):

What do you mean by “home-based child care”?

Home-based child care is care for children by someone who is not a parent or custodial caregiver of the child and that takes place in the home of the provider’s home (who may also be called a child care provider, caregiver, babysitter, or something else) or the home of the child’s home.

• Revised Provider Frequently Asked Questions and Community Member Flyer to better describe what the study means by community members (deletions shown with strike through and additions shown in bold text):

• Provider Frequently Asked Questions

Who else is participating in the study?

We will speak to people who take care of children across the country. In addition to your participation, we are interested in hearing from families that rely on you and people who give you information and support, who we are calling community members that support you. We’ll ask you to help us arrange interviews with family members of up to two of the children you care for and someone in your community who you feel helps or supports you around your taking care of children.

• Community member flyer

Why do you want to hear from community members?

We want to hear from people, who we are calling community members of the community, who are a source of give information and support (formal or informal) to providers who care for children. Your experiences will help us understand the types of resources and supports that could benefit child care providers.

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