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Medical College of Wisconsin
INTRODUCTION TO THE INFORMED CONSENT
Peak Team and Brain Agents Evaluation:
Parent/Legal Guardian Consent for Child’s Participation
John Meurer, MD, Lead Researcher
Institute for Health & Equity
414-955-8029
Medical College of Wisconsin
Subject: You are invited to take part in this research. This form tells you why this project is being done, what will happen in the project, and possible risks and benefits to you. If there is anything you do not understand, please ask questions. Then you can decide if you want to join this project or not. If you are under the age of 18, your parent or guardian also needs to give their permission for you to join this project.
Parent/Guardian: Your child is invited to take part in this research. This form tells you why this project is being done, what will happen in the project, and possible risks and benefits to your child. If there is anything you do not understand, please ask questions. Then you can decide if you want your child to join this project or not. The word “you” in this form refers to your child.
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Definitions Adversity: Most children experience some adversity. Possible adverse experiences include the stresses of poverty; racism; death, jail, or substance misuse among family and close friends; being bullied; and frequent moves STRYV365 is a non-profit based in Milwaukee that provides programs to address youth adversity and stress. Peak team are STRYV365 coaches who work in schools to foster resilience (bounce back, grit), kindness, responsibility, trust, and wellness among youth. Brain Agents is a fun video game that teaches similar lessons as the peak team coaches. Purpose This project is being done to assess the effect of the peak team program and Brain Agents game on youth feelings, behavior, and schoolwork Activities There are 4 activity groups in this project: peak team, Brain Agents, both peak team and Brain Agents, and a comparison group with no programs. All students in the same school and grade will get the same activity in the fall and a different activity in the spring of this year and again next year. Surveys: Students will do surveys in October, December, and May this school year and next year before and then after experiencing peak team and/or Brain Agents. - Total Number: 6 surveys - Total Time: Peak Team survey 8-10 minutes each. Brain Agents survey 2-4 minutes each. Focus groups: In January and May of this school year and next year, up to 45 students yearly in grades 5-7 across 3 schools may volunteer for focus groups about their experiences with the programs. - Total Number: 1 focus group per student - Total Time: 45 minutes Interviews: In January and May of this school year and next year, up to 35 students yearly in grades 8-9 across 4 schools may volunteer for interviews about their experiences with the programs. - Total Number: 1 interview per student - Total Time: 30 minutes Procedures that will occur at various visits: Invasive Procedures: none Non-invasive Procedures: see above Length You will be in this research project during this school year and next year. Research activities will occur for up to 20 months. Risks This is a brief list of the most commonly seen risks. The full consent form after this introduction contains a more complete list of potential research risks. Project risks: The privacy of students and families and confidentiality of their data will be protected. If the surveys or interviews trigger concerns about student feelings, school counselors will be available. Benefits This project may or may not help you, but we hope the information from this project will help us to develop better programs to address adversity and stress in youth. My Other Options You do not have to join this project. You are free to say yes or no. Whether or not you join this evaluation, your child will get peak team services and the Brain Agents game. If you have more questions about this project at any time, you can call lead researcher Dr. John Meurer at 414-510-0375.
If you have questions about your rights as a participant, want to report any problems or complaints, or offer input, you can call the MCW/Froedtert Hospital Research Subject Advocate at 414-955-8844. |
CONSENT TO PARTICIPATE IN RESEARCH
A1. INTRODUCTION – WHY ARE WE ASKING YOU TO PARTICIPATE?
Your child is being invited to join in this research evaluation because they are a student in grades 5-9 at Deer Creek/St Francis Schools, Milwaukee Academy of Science, or Brown Deer Schools, or grade 9 at Howard Fuller Collegiate Academy.
A total of about 1,700 students are expected to participate in this research evaluation in Milwaukee.
The Director of the project is John Meurer, MD, in the MCW Institute for Health & Equity. A research team works with Dr Meurer. You can ask who these people are.
The research evaluation will be funded by STRYV365.
A2. DO I HAVE TO PARTICIPATE?
You can decide whether to take part in this research or not. You are free to say yes or no. Even if you join this project, you do not have to stay in it. You may stop at any time. Take as much time as you need to make your choice.
A3. WHY IS THIS PROJECT BEING DONE?
The purpose of this project is to describe the social and emotional needs of students and to evaluate the effects of the peak team program and Brain Agents game.
B1. WHAT WILL HAPPEN IF I PARTICIPATE?
Activities: There are 4 activity groups in this project: peak team, Brain Agents, both peak team and Brain Agents, and a comparison group with no programs. All students in the same school and grade will get the same activity in the fall and a different activity the sping this school year and again next year.
Surveys: Students will do surveys in October before the programs begin, in December and May this school year and next year.
The peak team survey takes 8-10 minutes. The Brain Agents survey takes 2-4 minutes. The surveys ask about adverse experiences, wellbeing, optimism, coping, emotions, social support, mood, and relationships. We expect the programs will foster resiliency (bounce back, grit), kindness, responsibility, trust, and wellness.
Focus groups: In January and May this school year and next year, 45 students yearly in grades 5-7 across 3 schools may volunteer to do a 45-minute audio-recorded focus group about their experience with the programs.
Interviews: In January and May this school year and next year, 35 students yearly in grades 8-9 across 4 schools may volunteer to do a 30-minute interview about their experience.
All students in grades 5 through 9 will be invited to focus groups and the interviews. Students who note interest will be randomly chosen to represent the grades and schools.
Personal identifier: Students will assent to joining the evaluation. They will provide their name, date of birth, grade, and school in surveys to track their individual responses over time. After linking their survey answers and school records, their name will be deleted from the data for analysis.
School records: With your consent, your child’s school will provide school records from the fall of last school year through the spring of next school year about your child’s attendance; any discipline actions or suspensions; English, language arts, and math state exam performance; and failure of any classes. We expect that peak team and Brain Agents may help to improve school performance and want to measure it. After the records are linked to your child’s surveys, their name will be deleted from data for analysis. Those confidential records will never be publicly reported.
B2. HOW LONG WILL I BE IN THE PROJECT?
Your child will be in this research project for about 20 months.
B3. CAN I STOP BEING IN THE PROJECT?
You may stop at any time. If you decide to leave the project, please let the research team know.
C1. WHAT HEALTH RISKS OR PROBLEMS CAN I EXPECT FROM THE PROJECT?
We watch everyone in the project for unexpected problems. You need to tell the research leader or a member of the research team immediately if you experience any problems or your child becomes too upset.
Surveys, focus groups, and interviews: You or your child may feel that some of the questions we ask are stressful or upsetting. If they do not want to answer a question, they may skip it and go to the next question, or they may stop immediately. If your child becomes upset, please let us know and we can provide counselors or give you information about professionals who may be able to help.
Another risk may be loss of confidentiality. Every effort will be made to keep your research records confidential but we cannot guarantee it. Depending on the kind of information being collected, if your research information were accidentally seen, it might be used in a way that could embarrass you or affect your ability to get insurance. If you have questions, you can talk to the project director about whether this could apply to you.
C3. ARE THERE ANY BENEFITS TO TAKING PART IN THE PROJECT?
This project may or may not help your child, but we hope the information from it will help us develop better programs.
D1. ARE THERE ANY COSTS TO BEING IN THE PROJECT?
There are no costs to you for any of the programs that your child gets in this project.
D2. WILL I BE PAID FOR PARTICIPATING IN THE PROJECT?
Parents and students will not be paid to join this study.
D6. WHO CAN ANSWER MY QUESTIONS ABOUT THE PROJECT?
- If you have more questions about this project at any time, you can call Dr Meurer at 414-510-0375, or STRYV365 staff at 262-358-5212.
- If you have questions about your rights as a research participant, want to report any problems or complaints, or offer input, you can call the MCW/Froedtert Hospital Research Subject Advocate at 414-955-8844.
CONSENT/ASSENT TO PARTICIPATE
By signing my name below, I confirm the following:
- I have read (or had read to me) this entire consent document. All of my questions have been answered to my satisfaction.
- The project’s purpose, procedures, risks and possible benefits have been explained to me.
- I agree to let the research team use and share the health information and other information gathered for this project.
- I voluntarily agree to participate in this research project. I agree to follow the procedures as directed. I have been told that I can stop at any time.
IMPORTANT: You will receive a signed and dated copy of this consent form. Please keep it where you can find it easily. It will help you remember what we discussed today