Introduction
You are being asked to participate in a research study at OhioGuidestone called “Joyful Together® Babies & Children Playtime Study for Ohio-based Home Visiting” or “Joyful Together ODH” for short. The word “you” in this document refers to a parent/guardian caregiver.
You are being asked to participate in this study because you and your child are Ohio residents (“lives in Ohio”), participating in Help Me Grow programming, and your child is between 12 weeks/3 months and 6 years old. Parent/caregivers and their child will participate as a pair together.
Your participation in this study is voluntary and is not required to receive services from OhioGuidestone, Help Me Grow, or any other Ohio Department of Health related program. If you currently receive services from OhioGuidestone, or any other Ohio Department of Health related program, your current services will not be affected if you do or do not choose to participate. Please read the information below and ask questions to better understand this research study.
Purpose of the Study
OhioGuidestone wants to create and study a short evidence-based intervention that will help children and parent/guardians to play more and feel joy together. The intervention wants to help children experience joy at an early age in hopes of building strengths in children to help them face life’s stressors. Evidence-based interventions are a type of activity that uses research results to support and improve services.
Procedures
Your assigned Help Me Grow staff person will tell you about the research study in a conversation and give you a flyer with information about Joyful Together ODH. If you are interested in participating, staff will review this document to explain the research study and allow you to ask questions. If you agree to participate in the study you will sign an informed consent form (this document) and complete study activities.
You will begin study sessions once you have signed the informed consent and joined the study. There is a chance that you may be placed on a “waitlist.” If you are placed on a waitlist you will still participate in the study, but will do study sessions at a later date once the participant list becomes shorter. Study staff will inform you when you have been moved off of the waitlist.
Your participation in this research study will have two parts: Part 1 and Part 2.
What Study Paperwork will I do?
During both Part 1 and Part 2 you will fill out study paperwork—study forms and questionnaires. These will take you about 15-30 minutes to complete. Study staff can help you fill out the forms, and some forms can be filled out on the internet or during videoconference study sessions. Some questionnaires may be completed more than one time at the beginning, middle, and end of the study.
Forms & Questionnaires:
- Child Survey - survey about your child's strengths and behavior
- Parent Stress Survey - questions about general life stress, and stress connected to being a parent
- Family Survey - questions about strengths, needs, and differences for your family
- Enrollment Form - basic questions about you and your family
- Joyful Together® Feedback - questions about which Joyful Together® games your family uses
- Weekly Joy Calendar - counts activities tried each week; questions about your opinions of the activities
What will I do in Part 1 of the study?
Your participation in Part 1 will last for about six (6) weeks (will finish after six (6) Help Me Grow appointments (or six (6) Help Me Grow appointments after you are off of the waitlist). Your Help Me Grow staff will tell you more about Joyful Together® during regular appointments. For the research study, you will keep track of how many activities you try with your child, and your opinion about the activities you tried on the Weekly Joy Calendar. The research study also has surveys you will complete using a paper copy, or electronically from your phone, tablet, computer or other internet-connected device.
This image breaks down the steps of Part 1 of this research study.
What will I do in Part 2?: PART 2 Information
Your participation in Part 2 will take place six (6) months after you finish Part 1 of the study. Part 2 is also called the follow-up part of the research study.
During Part 2 you will only do four (4) questionnaires. You may be done with your Help Me Grow program by then; that is ok! Study staff will contact you to provide instructions on how you will do the Part 2 questionnaires. You will have 3 options to complete Part 2: online you will use a special number called an “Access Code” to log into a special page on our website), by phone, or by mail (we will give you a stamped envelope to send back to us).
We will email and call you to remind you about the one-time 6-month follow-up. 6 months from finishing this part of the study, we will reach out to you and send you a link (or mail you forms, or complete over the phone) to fill out 4 surveys (repeat 3 surveys from this part of the study, and a feedback survey asking if you still use Joyful Together®). We will email and call with reminders about four (4) times.
Potential Risks
Some survey questions might ask about your life experiences, and might make you feel uncomfortable or even emotional. Study staff are available to talk through any discomfort, feelings or thoughts during or after filling out your study questions. If needed, they will tell you about other services to get more help about what made you feel uncomfortable or emotional. There are no other known potential risks associated with participation.
Anticipated Benefits
You may or may not benefit from this study. Possible benefits may include:
- Better relationship between child and parent/guardian
- Increased fun and play in you and/or your child
- Increased positive emotions and feeling in you and/or your child
Information learned from this research study may also benefit future children and families.
Thank You Gift
You will receive a parent version of our Joyful Together book at the start of the study to do activities at home. You will get to keep this book.
You will also receive a $25.00 gift card for you and your family as a as a thank you gift for participating after you finish Part 1. If you have more than one child who participated with you in the same study, you will complete separate paperwork and questionnaires for each child -- and receive a gift card for each parent-child pair. You will also receive a $10.00 gift card to say thank you at the end of part 2.
Confidentiality
Your information will be kept confidential and only used for this research study. Only people working on this research study will have access to your study information. None of the surveys or information we ask for in this research study will be saved or added to your notes or files with Help Me Grow.
We will collect your demographic information, but a unique number instead of your name or other identifying information will be used on study documents. Your name or anything else that could identify you will not be included in reports, presentations or publications from this study. Your information will be kept in a locked file cabinet in a locked room, and computer files will only be opened on password protected computers. All documentation with identifying information will be destroyed once the study has ended.
Voluntary Participation and Withdrawal
Your participation in this study is completely voluntary (only if you want to). If you choose not to participate, it will not affect your relationship with OhioGuidestone, Help Me Grow, or any other Ohio Department of Health-related programming. You will still have the right to services that you are eligible for at OhioGuidestone, Help Me Grow, and any other Ohio Department of Health-related programming. You will not be treated differently if you decide not to participate.
If you decide to participate, you are free to change your mind and withdraw your consent (permission) and stop at any time. You will not be treated any differently if you decide to withdraw from the study. If you withdraw from the study, you can still continue to receive Help Me Grow services, and other services you are eligible for at OhioGuidestone or other Ohio Department of Health-related programming.
If you do participate in this study, your access to current and future services and client rights will not be changed or different.
There is no cost to participate in this research study.
Contacts and Questions
If you have any questions about this study, you can contact the study leader at: research@ohioguidestone.org or 440-260-8865. If you have any questions about your rights, or want to talk to someone different about this study, you can contact OhioGuidestone’s Client Advocate at 440-260-8308.
You may also ask research staff any questions that you may have now, or at any point during the research study.
Signature of Research Subject
Informed consent to participate in research is very important. By signing below you agree:
- That you have read the information about this research study;
- You have been given the chance to ask questions and they have been answered;
- You have the option to participate in the study and not agree to record play sessions;
- You volunteer to participate in the study and understand that you can withdraw from the study at any time.
A copy of this consent form will be provided to you.