Appendix A Director Consent

IRB TEMPLATE Version 2.2 - 10/26/2020 - Do not alter this text box

University of North Carolina at Chapel Hill
Consent to Participate in a Research Study
Adult Participants: Head Start Directors/Administrators

Consent Form Version Date: ______________
IRB Study # 21-2939
Title of Study: Evaluation of Ready to Learn through Relationships (RLR) in Head Start
Principal Investigator: Desiree Murray
Principal Investigator Department: Center for Health Promotion and Disease Prevention
Principal Investigator Phone number: (919) 843-1904
Principal Investigator Email Address: [email protected]
Funding Source and/or Sponsor: Education Development Center, Inc.

The purpose of this study is to evaluate a program for bringing trauma informed care to preschool classrooms called the Ready to Learn through Relationships (RLR) Toolkit and Framework. As part of this study, participating teachers and coaches will receive different levels of Training and Technical Assistance (TTA) so that we can find out what is most useful for promoting trauma-informed classroom practices. As a Center Director, we would ask you to provide support for these staff to participate in these activities as well as in the evaluation. Your participation in the study would include providing information about your Center in a virtual meeting with RLR staff and sharing feedback about the program in a 1:1 interview. Participation will last for approximately 9 months, from August/September of 2022 to May/June of 2023.

The greatest risk to you of participating in this study is a loss of confidentiality. However, we have put several procedures in place to protect the privacy of information you share with us.

What are some general things you should know about research studies?
You are being asked to take part in a research study.  To join the study is voluntary. If you do not want to participate, your Center will not be able to join the study.

You may choose not to participate, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future.  You may not receive any direct benefit from being in the research study, although we are providing training and supports that you may find beneficial. There also may be risks to being in research studies.

Details about this study are discussed below.  It is important that you understand this information so that you can make an informed choice about being in this research study. 

You will be given a copy of this consent form.  You should ask the researchers named above, or staff members who may assist them, any questions you have about this study at any time.

What is the purpose of this study?

The purpose of this research study is to determine the intensity of professional development supports needed for preschool teachers to effectively use trauma-informed care practices in their classrooms, and to evaluate the relative benefit of more intensive supports. Although practice-based coaching is recognized as a best practice for early childhood educators, it is not clear what types of coaching or how much coaching is needed. This study could inform approaches in early childhood training and technical assistance (TTA) in the future, particularly those used in Head Start, which is the focus of this work. We will also learn about a new way of evaluating teacher practice change through brief daily reports called Ecological Momentary Assessment (EMA) that may be useful for education research more broadly.

Specifically, we will examine the following research questions:

1. What is the feasibility and fidelity of the RLR program when implemented with different levels of coaching?

2. How satisfied are teachers and coaches with the RLR program?

3. How much does knowledge and attitudes about trauma-informed care change with participation in the RLR program?

4. How do teacher practices change in key areas associated with trauma-informed care, including creating a safe environment, healthy relationships, supporting emotion regulation, and using self-care.

You are being asked to be in the study because your perspective as a director or administrator at your Center is valuable to our evaluation.

Are there any reasons you should not be in this study?
You should not be in this study if you do not expect to remain at your Center through this school year.

How many people will take part in this study?
Approximately 70 people at about 10 Head Start Centers will take part in this study, including teachers, coaches, and directors.

How long will your part in this study last?
Your participation in this study would last approximately 10 months, over the course of the 2022-2023 Head Start school year. All study activities can be completed remotely through virtual meetings. We estimate that the total time required for evaluation activities is approximately 2 hours After the program is completed and final interviews done, there is no further follow up.

What will happen if you take part in the study?
You will be invited to participate in two one-hour interviews. The first interview will occur at the beginning of the program in the fall of 2022. In this meeting, the RLR team will meet virtually with you to review information you provided on your Center’s application for the study, to better understand the needs and assets of your Center. At the end of the program in May of 2023, RLR evaluation staff would meet with you to learn more about your perspectives and experiences with the program, including its fit and impact, challenges and areas for improvement, and other organizational and contextual factors you perceive as relevant. During the interview, you may choose to respond or not respond at any point. We would like to audio-record the interviews so we can capture your comments in a transcript for analysis.

You can choose whether or not you would like to be audio-recorded. Check the line that best matches your choice:
_____ I agree to be audio-recorded during these interviews.
_____ I do not want to be audio-recorded during the interviews.

Research staff will provide instructions for completing all evaluation activities. You may choose to not to answer any questions for any reason.

What are the possible benefits from being in this study?
Research is designed to benefit society by gaining new knowledge. The benefits to you from being in this study may be that you would gain knowledge and skills related to trauma-informed care that are known to be helpful for young children’s social-emotional development.

What are the possible risks or discomforts involved from being in this study?
There are no known risks to completing the types of surveys and feedback sessions in this study. However, there may be uncommon or previously unknown risks. You should report any problems to the researcher.

What if we learn about new findings or information during the study?
You will be given any new information gained during the course of the study that might affect your willingness to continue your participation. 

How will information about you be protected?
To protect your privacy, we will use a code number instead of your name to identify you. Only research team members will know what name goes with what code number. The list that matches names and code numbers will be kept on a secure network in a password protected electronic file. Any physical copies of data will be stored in locked filing cabinets or in locked offices. No one outside the research team will have access to individually identifiable data gathered by the researchers about you.

All of the interview recordings and transcripts will be stored on secure servers that meet UNC-CH’s data security requirements. Audio-recordings will be destroyed following final analyses. Any data summaries, reports, or publications will remove all information about you that could potentially be identifiable (e.g., race, ethnicity, years of service, grade level). We will not report on any groups of individuals that are small enough that someone’s identity could be determined. We may use de-identified data from this study in future research without additional consent.

Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information.  This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information.  In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or our funders for purposes such as quality control or safety.

The study team would like to communicate with you by e-mail to share information about the study and coordinate participation logistics. However, you may say “no” to receiving these messages and still participate in this study if we can reach you by phone.  If you say “yes”, it is important that you know that unencrypted messages may contain personal information about you and may be sent or received by the study team’s personal electronic devices or in a method that is not able to be encrypted (protected) and there is the risk your information could be shared beyond you and the study team. 

If you wish to stop receiving unprotected communication from the study team or change your phone contact information, please notify the study team using the study contact information on the first page of this consent form.   After the study is complete and all research activities finished, or you withdraw from the study or request to stop receiving unprotected communication, you will no longer receive un-encrypted (un-protected) messages specific to this study.

_____ Yes, I consent to the study team utilizing the following to communicate with me:

Email: __________________

_____ No, I do not consent to receive un-protected communication from the study team.  

What will happen if you are injured by this research?

All research involves a chance that something bad might happen to you.  If you are hurt, become sick, or develop a reaction from participating in this study, the researcher will help you get any needed care, but the University of North Carolina at Chapel Hill has not set aside funds to pay you for any such care.  You may be responsible for the costs of needed care.

If you think you have been harmed from taking part in this study, call the Principal Investigator at the phone number provided on this consent form.  They will let you know what you should do. 

By signing this form, you do not give up your right to seek payment or other rights if you are harmed as a result of being in this study.

What if you want to stop before your part in the study is complete?

You can withdraw from this study at any time, without penalty.  The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

If you decide to withdraw, please contact the investigator. If you withdraw or are withdrawn from this study, all data collected up until the point of withdrawal will be kept. However, no additional information will be collected unless you provide additional written permission for further data collection at the time of your withdrawal. 

Will you receive anything for being in this study?
You will not receive anything for taking part in this study.

Will it cost you anything to be in this study?
It will not cost you anything to be in this study. 

Who is sponsoring this study?
This research is funded by the Administration for Children and Families (ACF) at the Department of Health and Human Services (HHS), through a subcontract from the Education Development Center, Inc. (EDC). This means that the UNC research team is being paid by EDC, who is paid by HHS, for doing the study.  The researchers do not, however, have a direct financial interest with the sponsor or in the final results of the study.

What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study, complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form.

What if you have questions about your rights as a research participant?
All research on human volunteers is reviewed by a committee that works to protect your rights and welfare.  If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to [email protected]. 

Participant’s Agreement:

I have read the information provided above.  I have asked all the questions I have at this time.  I voluntarily agree to participate in this research study.

______________________________________________________
Signature of Research Participant
____________________
Date
______________________________________________________
Printed Name of Research Participant 

______________________________________________________
Signature of Research Team Member Obtaining Consent
____________________
Date
______________________________________________________
Printed Name of Research Team Member Obtaining Consent   

21-2939 Adult Consent Form Page 1 of 1