Form 0923-0061 Wave One Eligibility Screening Script

Attachment 6c.

Pease Study

Wave One Eligibility Screening Script

Flesch-Kincaid Readability Score – 5.8

Form Approved

OMB No. 0923-0061

Exp. Date xx/xx/201x xx/xx/20xxExDaxx/xx/20xx

Exp. Date xx/xx/20xx

Pease Study – Wave One Eligibility Screening Script

ATSDR estimates the average public reporting burden for this collection of information as 10 minutes per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. 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. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0923-xxxx).

(This script will be used to screen adult and parent/child volunteers who respond to the NH DHHS Invitation Letter to former Biomonitoring Program participants. They will be instructed to call ATSDR on the toll-free number.) [SHADED TEXT DENOTES INFORMATION COLLECTION]

Hello. My name is _____________. I’d like to thank you for calling about the Pease Study.

I understand that you received a letter from the New Hampshire Department of Health and Human Services about volunteering for the Pease Study. As you know, the Agency for Toxic Substances and Disease Registry, or ATSDR for short, would like to recruit people for the Pease Study who already took part in the Pease Biomonitoring Program. If there are more people in your house who took part and are interested, I’d like to start with you first.

ATSDR will take COVID-19 prevention measures at every step of our work in your community. Would you like me to tell you about those?

If the participant says “no”, move on with the script.

If the participant says “yes”, tell them the following:

The Pease Study will be conducted following all state, local, and CDC guidelines in place at the time the data collection is conducted. Pease Study team members will be monitored twice daily for fever and any COVID-19-related symptoms and will wear masks and gloves to ensure the protection of participants. Similarly, participants will be monitored for fever and COVID-19-related symptoms prior to their entry into the testing facility and will be asked to wear a face covering or mask. If you do not have a mask, one will be provided to you.

[Screening Questions for ADULT – If a PARENT calls who is not going to enroll as an ADULT > go directly to Screening Questions for PARENT/CHILD]

A1. I’m happy to hear that you received the invitation letter as a past participant in the Pease Biomonitoring Program. Are you 18 years or older?

• YES > go to A2.

• NO (under 18) > OK, can I speak to your parent or guardian? [becomes PARENT ONE] > go to Screening Questions for PARENT/CHILD.

A2. Have you ever worked as a firefighter or ever participated in training exercises using firefighting, or AFFF, foam?

• YES > I’m sorry. People who ever worked as a firefighter or used firefighting foam are not eligible for this study. > go to Screening Questions for PARENT/CHILD.

• NO > go to A3.

A3. Have you ever worked at industrial facilities that used PFAS chemicals in the manufacturing process?

• YES > I’m sorry. People who ever worked at facilities using PFAS chemicals are not eligible for this study. > go to Screening Questions for PARENT/CHILD.

• NO > Thank you very much. You are eligible to take part in the Pease Study as an adult participant. > go to A4.

A4. Are you in prison or under house arrest?

• YES > I’m sorry. The federal regulations say that people who are in prison or under house arrest cannot be in this study. > go to Screening Questions for PARENT/CHILD.

• NO > Thank you very much. You are eligible to take part in the Pease Study as an adult participant. > go to A5.

A5. If you want to enroll in the Pease Study as an adult participant, I will need your contact information to send you some recruitment materials and to set up an appointment.

Record ADULT Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

After the call is over, enter the assigned ADULT STUDY ID number to begin tracking enrollment and biospecimen sample logistics. Be sure to link the ID numbers for an individual who has both an ADULT STUDY ID and one or more PARENT STUDY IDs.

• ADULT STUDY ID |__________________________|

A6. The study interview will take place at our central study office at (address). We would like to conduct the study there, but we know some people may find it difficult to travel. For some cases, we are willing to send an interview team to their homes as long as it is within a one-hour drive from the central office. We are also offering you the option to answer the survey questions portion over the phone. Which location works best for you?

Record Appointment Location

• CLINIC OFFICE

• ADULT HOME

A7. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

A7a. If participant requests conducting survey questions over the phone. Let’s schedule a day and time for your call to answer the survey questions. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

A8. Thank you for your interest. We will mail you a packet of information including consent forms that shows what to expect at your appointment. We will also mail instructions. They will tell you how to prepare and what to bring.

A9. Adult participants may also enroll as parents of children in this research. Are there any children in your household who received an invitation letter?

• YES > go to Screening Questions for PARENT/CHILD.

• NO > OK. Thank you very much for your interest. We will mail your Appointment Packet shortly. If there are any other adults in your household who received an invitation letter, I will be happy to speak to them now, or at another more convenient time. Thanks again. > When additional adults are available, begin at A1.

[Screening Questions for PARENT/CHILD]

For this research study, ATSDR is recruiting children who took part in the Biomonitoring Program and received an invitation letter from the New Hampshire Health Department. We are looking for about 350 interested parent/child pairs to enroll. A parent may also enroll with more than one child who took part in the Biomonitoring Program.

P1. For each child, 4-17 years old, who received a letter and is interested in taking part in the Pease Study, I need to speak to the parent or guardian who wants to enroll with his or her child. We think it is best if the child’s birth mother enrolls. That is because we will ask a lot of questions about when your child was a baby. Am I speaking to the right person?

• YES > Thank you. I need to find out a bit more about each child who wants to be in the Pease Study. If you have more than one, let’s start with the youngest.

• NO > OK, I’d like to speak to that parent or guardian. If this isn’t a good time, he or she can call our office later. If now is a good time, let’s start with the youngest.

  • If correct parent not available, stop > OK, we will be waiting for that parent to call our office. Thanks very much for your interest.

  • If correct parent available, go to P2.

P2. How old is [CHILD 1; CHILD 2; CHILD 3; etc.]?

• AGE |__|__| years > eligible age is 4-17 years >

  • If not age eligible, go to P2a.

  • If age eligible, go to P3.

P2a. I’m sorry. We are looking for children 4-17 years. Do you have other children who are 4-17 years?

• YES > OK, let me find out more about them. > go back to P2.

• NO > Thank you very much for calling us today. It appears that your children are not eligible to take part in the Pease Study. We appreciate your interest in this research.

P3. Has [CHILD 1; CHILD 2; CHILD 3; etc.]’s birth mother ever worked as a firefighter or ever participated in training exercises using firefighting, or AFFF, foam?

• YES > I’m sorry. Children whose birth mother ever worked as a firefighter or used firefighting foam are not eligible for this study. If you have other children who are 4-17 years, let me ask these same questions about him or her. > go back to P2. If no more children, go to P3a.

P3a. Thank you very much for calling us today. It appears that your children are not eligible to take part in the Pease Study. We appreciate your interest in this research.

• NO > go to P4.

P4. Has [CHILD 1; CHILD 2; CHILD 3; etc.]’s birth mother ever worked at industrial facilities that used PFAS chemicals in the manufacturing process?

• YES > I’m sorry. Children whose birth mother ever worked at facilities using PFAS chemicals are not eligible for this study. If you have other children who are 4-17 years, let me ask these same questions about him or her. > go back to P2. If no more children, go to P4a.

P4a. Thank you very much for calling us today. It appears that your children are not eligible to take part in the Pease Study. We appreciate your interest in this research.

• NO > go to P5.

P5. Is your child in juvenile detention or under house arrest?

• YES > I’m sorry. The federal regulations say that people who are in juvenile detention or under house arrest cannot be in this study. > go to Screening Questions for PARENT/CHILD.

• NO > Thank you very much. Your child is eligible to take part in the Pease Study as a participant. > go to P6.

P6. I will need your contact information to send you some recruitment materials and to set up an appointment.

P6a. Record PARENT 1 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P6b. Record CHILD 1 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• PARENT 1 STUDY ID |__________________________|

• CHILD 1 STUDY ID |__________________________|

P6c. The study interview will take place at our central study office at (address). We would like to conduct the study there, but we know some people may find it difficult to travel. For some cases, we are willing to send an interview team to their homes as long as it is within a one-hour drive from the central office. Which location works best for you?

Record Appointment Location

• CLINIC OFFICE

• ADULT HOME

P6d. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P7. If you have another eligible child who would like to enroll, I will fill in his or her contact information, too. Let me go back through the screening questions. > go back to P2. If no more children, go to P6a.

P7a. Thank you very much for your interest. We will mail your child’s Appointment Packet shortly. Thanks again.

P7b. Record PARENT 2 Contact Information

• FIRST NAME |__________________________| (enter “SAME AS PARENT 1” if applicable > go to P6c)

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P7c. Record CHILD 2 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|(enter “SAME AS PARENT 1” if applicable > go to P6d)

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• PARENT 2 STUDY ID |__________________________|

• CHILD 2 STUDY ID |__________________________|

P7d. Which location for your interview works best for you?

Record Appointment Location

• CLINIC OFFICE

• ADULT HOME

P7e. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P8. If you have another eligible child who would like to enroll, I will fill in his or her contact information, too. Let me go back through the screening questions. > go back to P2. If no more children, go to P7a.

P8a. Thank you very much for your interest. We will mail your children’s Appointment Packets shortly. Thanks again.

P8b. Record PARENT 3 Contact Information

• FIRST NAME |__________________________| (enter “SAME AS PARENT 1” if applicable > go to P7c)

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• WORK PHONE NUMBER |__________________________|

• HOME PHONE NUMBER |__________________________|

• CELL PHONE NUMBER |__________________________|

• EMAIL |__________________________|

P8c. Record CHILD 3 Contact Information

• FIRST NAME |__________________________|

• LAST NAME |__________________________|

• STREET ADDRESS |__________________________|(enter “SAME AS PARENT 1” if applicable > go to P7d)

• CITY |__________________________|

• STATE |__________________________|

• ZIP CODE |__________________________|

• DATE OF BIRTH |__|__|/|__|__|/|__|__| > verify age eligibility

• PARENT 3 STUDY ID |__________________________|

• CHILD 3 STUDY ID |__________________________|

P8d. Which location for your interview works best for you?

Record Appointment Location

• CLINIC OFFICE

• ADULT HOME

P8e. Let’s pick a good day and time for you. > Record Appointment Information

• DAY |_________________|

• DATE |__|__|/|__|__|/|__|__|

• TIME |__|__|:|__|__| AM PM

P9. (CLOSING REMARKS) Thank you very much for your interest. We will mail your [child’s/children’s] Appointment Packet(s) shortly. Thanks again.

P10. Data Linkages

After the call is over, enter the assigned PARENT (1,2,3, etc.) STUDY ID number(s) to begin tracking enrollment and biospecimen sample logistics for each child. Be sure to link the ID numbers for an individual who has both an ADULT STUDY ID and one or more PARENT STUDY ID aliases.

• ADULT STUDY ID |__________________________| (IF APPLICABLE ALIAS)

• PARENT 1 STUDY ID |__________________________|

• PARENT 2 STUDY ID |__________________________| (IF APPLICABLE ALIAS)

• PARENT 3 STUDY ID |__________________________| (IF APPLICABLE ALIAS)