Introduction
You are being asked to participate in a research study being done at OhioGuidestone and Alta Behavioral Healthcare called "Joyful Play". The word "you" in this document refers to a parent/guardian.
You are being asked to participate in this study because you or your child is an OhioGuidestone client or an Alta Behavioral Healthcare client. Parents/caregivers and their child are being asked to participate in this study if the child is between 12 weeks/3 months and 12 years old. Parent/caregivers and their child will participate as a pair together. Siblings of children, or household members, who are eligible OhioGuidestone or Alta Behavioral Healthcare clients are also welcome to participate in the study if they, too, are between 12 weeks/3 months and 12 years old.
Your participation in this study is voluntary and is not required to receive services from OhioGuidestone or Alta Behavioral Healthcare. 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 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 program interventionist (community mental health worker or therapist), child's teacher or research staff will tell you about the research study during one of your current appointments. 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 do study sessions.
You will begin study sessions once you have signed up for 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?: Forms and Questionnaires
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.
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
- Information Sheet- basic questions about you, your family, and your medical history
- Joyful Together® Feedback- questions about which Joyful Together® games your family uses
During both parts of the study we will collect information from you as well as your OhioGuidestone or Alta Behavioral Healthcare record about your health. If you and/or your child is an OhioGuidestone or Alta client we will get information from your health record and your questionnaires. For whichever person in your parent-child pair is not an OhioGuidestone or Alta client, we will get information from your questionnaires.
| Summary of Part 1 of Joyful Together® Study Procedures |
| Study Enrollment |
Learn about "Joyful Play" research study. |
Read Consent form and ask questions. Schedule 1st "Play Session". |
Fill out Study Questionnaires. |
| "Play Session" #1 |
Receive Joyful Together® Booklet and your Joy Calendar | Research staff helps you start Joyful Together® activities. |
After Play Session #1 you and your child will play games as much as possible every day from the Joyful Together® booklet. Fill out the Joy Calendar. |
| "Play Sessions" #2-5 |
Talk about what activities and games you and your child did.
Hand in your Joy Calendar. |
Do more Joyful Together activities with research staff. |
Schedule next "Play Session"
Keep playing games every day and filling out Joy Calendar between Play Sessions. |
| "Play Session" #6 |
Talk about your favorite activities and games you and your child did. |
Fill out Study Questionnaires |
After Play Session #6 you will get your thank you gift in the mail. |
What will I do in Part 2? PART 2 Information
Your participation in Part 2 will take place during two additional appointments: one 6 months and another 12 months after you finish Part 1 of the study.
During Part 2 you will only do questionnaires. You may be done with your OhioGuidestone 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 4 options to complete Part 2: online, by phone, by mail, or in-person.
- Online - If you want to complete the questionnaires online, you will use a special number called an "Access Code" to log into a special page on our website.
- By Phone - Study staff will do the questionnaires over the phone with you.
- In-Person Appointment - Study staff will come and do the questionnaires in person with you.
- By Mail - You can do the questionnaires on paper and mail the forms in.
Potential Risks
There are no 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.
You will receive a $20.00 gift card for you and your family as a thank you gift for participating once all of your paperwork has been returned for 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 thank you gift 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. 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. If you choose not to participate, it will not affect your relationship with OhioGuidestone. You will still have the right to services that you are eligible for at OhioGuidestone. You will not be treated differently if you decide not to participate.
If you decide to participate, you are free to withdraw your consent 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 will still continue to receive mental health services at OhioGuidestone.
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 team at research@ohioguidestone.org or 440.260.8865.
If you have any questions about OhioGuidestone's services, including client rights, you can contact the agency'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.