OMB Control No: XXXX-XXXX
Expiration Date: xx/xx/xxxx
Informed Consent Form for Participation in [PUBLIC-FACING STUDY NAME]
You are invited to take part in an important study called the [PUBLIC-FACING STUDY NAME]. It is a study of how peer mentors work alongside parents to try to help them reduce stress, achieve substance use recovery goals, and meet the requirements of their child welfare case. A company called Abt Associates runs the study. The Administration for Children and Families in the U.S. Department of Health and Human Services is paying for it.
Your experience is important. Your participation will help the research team learn more about the services that families get and help improve services for families in the future. Being in the study is completely up to you. Your decision will not change anything about your child welfare case or the services that are currently available to you. You can also decide to quit the study at any time. Leaving the study will not harm you in any way or affect your child welfare case or result in the loss of services. We hope you agree to be in the study.
This form gives information about the study and your role as a study participant. At the end of the form, you can tell us whether you want to be in the study. It is important that you read the entire form.
What does it mean to be in the study?
We are inviting over 2,000 parents from across the country to participate.
If you agree to participate, you will be assigned at random to one of two groups. One group will be able to participate in <<name of Parent Mentor Program>>. The other group will not be able to participate in this program but may be eligible for other services in the community. We do this because space is limited in the <<name of Parent Mentor Program>>. The random selection is a fair way to make sure that everyone eligible for the program has an equal chance of getting it.
The researchers will let your case worker know which group you were assigned to. After that, your case worker will refer you to relevant services based on your group assignment.
If you agree to be in the study, the research team will ask you to take part in the following study activities over 15 months. Even if you aren’t assigned to the <<name of Parent Mentor Program>> group, your experiences are important and we will still ask you to participate in study activities.
The researchers will ask you to complete two 45-minute surveys —once now, and again 15 months from now. You will receive a $40 gift card for completing each survey, or a total of $80 if you do both surveys. You will answer some survey questions with an interviewer and some by yourself on a computer. The survey will ask you about your strengths, relationships, experiences, thoughts, and feelings. Some questions are personal or ask about things that may be hard to think about like substance use, feeling sad or lonely, and experiences with child welfare. You can skip any question or take a break whenever you like.
The researchers will ask you to complete a short 10-minute contact update form every three months (four times). We will ask you to check and update your contact information and contact information for three people who will know how to reach you in case we have trouble. You will receive $5 as a thank you for completing each contact update form, or up to $20 if you complete all four contact update forms.
The researchers may use your name, date of birth, social security number (SSN) or other identification number to collect information about you. This includes some information kept by <<Name of state or local DHS agency>> like your child welfare case status. It may include information from Medicaid records kept by <<Name of state or local DHS agency>> about any treatment services you receive. If you are assigned to the group offered a peer mentor, it would also include information kept by the <<name of Parent Mentor Program>> like the dates you entered and exited the program.
What are the possible benefits and risks if I agree to participate?
By being in the study, you will help the researchers learn more about how peer mentors help families reduce stress, meet recovery goals, and achieve positive child welfare outcomes. The information learned from the study is intended to improve future services for parents like you.
There is little risk for you to participate in this study. There is a small risk that some of the survey questions may make you feel uncomfortable. You don’t have to answer all the questions and you can quit the study at any time.
The researchers will keep your personal information private, as much as the law allows. This means that your child welfare caseworker, your family members, and service providers will never see your answers. There is a small risk of a loss of privacy. However, the researchers have many safety measures to prevent this from happening. Any computer files with your name will be stored on a secure network that is protected by a very high level of encryption and a password.
Your name will never be used in any public document or data file created as part of the study. About 2,000 parents will be in this study. When the researchers write a report, your information will be combined with information from all the other people in the study. At the end of the study, a data file with anonymous versions of study participants’ data may be made available to the funder of the study and authorized researchers. The data in that file will not identify you individually.
To help us protect your privacy, we have a special certificate called a Certificate of Confidentiality. It adds special protection to your information. It says that we do not have to tell anyone who you are or that you are in the study. Even under a court order from a judge, we can say “no” to the request. The only time that we may have to tell someone is if we find out that you or someone else could be hurt or in danger.
Who should I contact if I have any questions about the study?
If you have any questions about the study, you can contact the researchers by email at R3Families@abtassoc.com. You can also contact the Abt Associates Study Director at 617-520-2502 (toll call) or by email at R3Families@abtassoc.com. For questions about your rights as a study participant, contact the Abt Associates Institutional Review Board at 877-520-6835 (toll-free call) or by email at IRB@abtassoc.com.
Consent to Participate
Your participation in this study is voluntary. This agreement is effective from the date you agree to it until the end of the study. If you choose to quit the study, this agreement will end at that time. You may choose to quit the study at any time without penalty. If you do quit the study, researchers will continue to use information collected during the time before you quit. To quit the study, please contact the Study Director, at 617-520-2502 (toll call) or by email at R3Families@abtassoc.com.
Consent:
Here, you tell us if you agree to be in the study. Please read this
carefully and ask a staff member if you have any questions about
what you are agreeing to.
Please
select one:
Yes,
I agree
to participate in the [name of study]. I agree to allow the
researchers to use my information as described above.
No,
I do not
agree to be in the [name of study].
To confirm your selection, please
enter your full legal name.
First Name:
________________________________________________________________ Middle Name (leave blank if you do not
have a middle name): ________________________ Last
Name:
________________________________________________________________ Signature:
_________________________________________________________________ Date:
_____________________________________________________________________
FOR STAFF USE ONLY: IF INFORMED CONSENT
WAS COLLECTED VERBALLY
☐ Informed consent was collected
verbally from the individual named above.
I,
[Enter Study
Liaison or
Abt
Local Interviewer’s
name,
depending on who completes verbal consent],
certify that I read the consent form in its entirety to the
individual named above and they provided their verbal consent to
participate in the study. Staff
Signature:
____________________________________________________________ Date of
Signature:___________________________________________________________
R3-Impact Informed Consent
Form Page
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Meredith Kelsey |
File Modified | 0000-00-00 |
File Created | 2023-08-18 |