Attachment C1: Parental Consent Version 2_07.13.2022

Attachment C1_Study Parental Consent_V2_clean.docx

Components Study of REAL Essentials

Attachment C1: Parental Consent Version 2_07.13.2022

OMB: 0990-0480

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ATTACHMENT C1

STUDY PARENTAL CONSENT FORM 

Form approved 

OMB Number: 0990-0480 

Expiration Date: 10/31/2024

CONSENT LETTER AND FORM

REAL Essentials Advance Study

We invite your child to participate in the Components Study of REAL Essentials Advance (REA)1. REA is a program that teaches youth the skills they need to have healthy relationships. More information about REA is in the attached summary. In addition to offering the program, your child’s school/CBO is participating in a study of REA during the 2022–2023 school year. The purpose of this study is to learn about the parts of programs that matter most for promoting healthy behavior and relationship skills in adolescents.

What does my child need to do?

  • Your child will be asked to complete up to three surveys over the next year. The survey questions will be about their background, attitudes about relationships, social and emotional well-being, and behavior. We will use the information to understand how REA affects healthy relationship skills and behavior. Your child will complete the surveys on the web, and they will each take about 40 minutes. They will take the first survey before the REA program starts. The next survey will be immediately after your child finishes the REA program. The final survey will be about six months after the program ends. You child will take all the surveys at [school/NAME OF CBO]. If your child does not complete a survey [in school/at NAME OF CBO], Mathematica staff may contact your child to complete the survey over the phone or on the internet. Your child will also receive a [INCENTIVE] for completing the survey immediately after they finish the REA program. If your child also completes the final survey six months later, they will receive a [INCENTIVE].

  • We will ask for information about your child’s attendance and involvement in the REA program. Your child will be asked to fill out a brief survey after each session of REA. These short surveys will have a few questions about your child’s involvement in the class, and ask for their feedback on REA.

  • Your child may be asked to participate in a focus group to learn more about their experience with REA. A focus group is a discussion Mathematica staff will guide with youth in the class. Groups last about an hour. During the focus group, your child and the other youth can share their thoughts about REA and what they liked about it. They can also share ideas about how the lessons could be better. Your child will not be asked about their own behavior. Not everyone will be selected to participate in the focus groups, but if your child does participate, they will receive a $25 gift card. Please note: your child may still participate in the study even if you do not give permission for them to be in the focus group. If you do not want your child to be part of the focus group, you can opt them out of that activity when you complete the form.



Keeping your child’s information private.

If you let your child participate, all the information your child contributes will be combined with information from other youth participating in the study. Your child’s name will not be connected to the answers they give. We will keep everything your child tells us private unless they tell us someone is hurting them, or they are hurting themselves. With your child’s permission, we will audio-record the focus group discussion to help us catch everything the participants say. If any child in the focus group does not agree to be audio-recorded, we will not record the group. If we do record, we will destroy the recording after we check our written notes. No one outside the study team will see any of your child’s (or other children’s) answers to surveys or focus groups. We have a Certificate of Confidentiality from the National Institutes of Health. This helps us protect your child’s privacy. This means no one can force the study team to give out information that identifies your child, even in court.

In the future, data from the surveys may be securely shared with qualified individuals who are seeking to learn more about adolescent health programs. That data will not include any information identifying individual children or participating organizations.

You can choose whether your child will be part of the study.

Participation in the study is voluntary. If you agree your child can participate, you or your child can choose to stop participating at any time with no consequences. Although there is no direct benefit to you or your child, you will be helping your child’s school, because they will learn more about this popular relationship education program. The only risk connected with the study is that your child might be uncomfortable answering some questions in the surveys. If that happens, your child can refuse to answer those questions. Your child can still be in REA even if they opt out of the study.



We need your response.

We need your response, whether it is yes or no. Please complete, sign, and return the attached [COLOR] form to your [your child’s teacher/NAME OF SOMEONE AT CBO] within one week by [RETURN DATE]. You can also complete the form online. Your child will receive a $5 gift card for returning the completed form, whether your answer is yes or no. Please keep the [COLOR] form for your records. If you have questions about the REA study, please call Melissa Thomas, Mathematica’s survey director, toll-free at 1-833-554-0083 between 9 a.m. and 5 p.m. Eastern Time, Monday–Friday. You may also contact us by email at [email protected].

The REA study has received approval from the Health Media Lab Institutional Review Board. If you have any questions about your child’s rights as a study participant, please contact the Health Media Lab Institutional Review Board at (202) 246-8504 or by email at [email protected].

Please complete and sign the enclosed permission form and return it to [your child’s school/NAME OF CBO] within one week. Thank you!




REAL Essentials Advance (REA) Study

Parent or Guardian Permission Form

Shape1

We need your answer, whether it is yes or no. Please submit by only one of the following methods:

Scan the QR code below with your smartphone to complete the permission form online [INSERT QR CODE]. If the code does not work for you, please go to [URL].

OR

Fill out the form and have your child return it to school. The second copy is for your records.











Shape2

I have read the information sheet describing the study. By signing this form, I am saying:

YES, I agree to all activities YES, I agree but opt out of focus groups NO, I do not give permission

for my child, _____________________________________, to participate in the study.

Print child’s name

In giving permission for my child to participate, I understand that trained staff will give three surveys to my child over the next year and collect information on attendance and engagement at each REA session. My child may also be asked if they would like to participate in a focus group. By giving permission for my child to be in the study, I agree that this information can be collected, and that my child may receive an email or text message to the numbers provided to arrange for them to participate in the follow-up survey. I understand participation is voluntary, and my child can stop at any time with no consequences. I also understand that all information on my child will be kept private and used only for the purposes of the study. If I have questions about my child’s rights as a study participant, I can call the Health Media Lab toll-free at (202) 246-8504.

Child’s Date of Birth: _____ / ______ / _____
Month Day Year

Parent/Guardian Signature: Date:






















Shape3

PLEASE TURN PAGE




If you said YES, please fill in the following information. We will use your contact information only if we need your help in contacting your child to complete a follow-up survey. We also ask you to provide contact information for someone who would know how to reach you in case you move and we cannot contact you. If we contact this person, we will not reveal any information about your child or the study, other than to say we need to locate your child to complete a survey. Thank you.


Parent or Guardian Name:

Street Address: _______________________________________________________ Apt: ___________

City: _______________________________________ State: ________ Zip Code: __________________

Telephone: (______)_____ - ___________ Home (_____) _____ - ____________ Cell

Email:


Alternate Contact Name:

Street Address: _______________________________________________________ Apt: ___________

City: _______________________________________ State: ________ Zip Code: __________________

Telephone: (______)_____ - ___________ Home (_____) _____ - ____________ Cell

Email:



Parents please be aware that under the Protection of Pupil Rights Act. 20 U.S.C. Section 1232(c)(1)(A), you have the right to review a copy of the questions asked of your child. If you would like to do so, you should contact your child’s [school/CBO] to obtain a copy of the questions.



1 The study is sponsored by the Office of Population Affairs in the U.S. Department of Health and Human Services, and is being conducted by Mathematica, an independent research company.

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