NCT06781840 · Yeshiva University
Promoting Health Through Play Program: Improving Parent and Child Outcomes
What this study is about
This project aims to assess the feasibility of an intervention program consisting of parent online group sessions in addition to guided individual play session between parent, child, and occupational therapy student (OTS) or an occupational therapist (OT). The investigators speculate that the Promoting Health Through Play Opportunities program will be effective in improving: 1.
View original scientific description
This project aims to assess the feasibility of an intervention program consisting of parent online group sessions in addition to guided individual play session between parent, child, and occupational therapy student (OTS) or an occupational therapist (OT). The investigators speculate that the Promoting Health Through Play Opportunities program will be effective in improving: 1. Parent ability to support their child's playfulness as measured during 15-minute video-recorded joint play activity at home using the Parent/Caregiver Support of Childre Playfulness \[PC-SCP\]. 2. Child's playfulness behavior as measured during 15-minute video-recorded joint play activity at home using the Test of Playfulness \[ToP\]. 3. Child's psychological adjustment as measured by the Strength and Difficulties Questionnaire \[SDQ\]. 4. Parent's perception and satisfaction from their involvement in the program as measured through open-ended questions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Enrolled in Head Start pre-school program within New York greater area
- Parent-child dyads
- Child must be 3 to 5 years old, with/without delay or disability.
- If a parent has more than one child in this age range, the oldest of them will be recruited for the study
- Parent IS committed to attending pre-and-posttest as well as online group sessions
- Parent has access to a device other than a phone (tablet, iPad, laptop) and has stable internet connection to be able to participate in the online group and dyadic session
- For the English-speaking group, parent must be fluent in English
- For the Spanish speaking group, parent must be fluent in the Spanish language.
Exclusion criteria
- Parents with a sensory deficit (e.g., hearing or vision impairment) that will affect their ability to participate in an online group program
- Parents with psychiatric or behavioral disorders that affect their ability to participate in a group-based intervention
Where
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 17, 2025 · Source of record for eligibility and locations