- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06781840
Promoting Health Through Play Program: Improving Parent and Child Outcomes
January 13, 2025 updated by: Yeshiva University
The Feasibility of the Promoting Health Through Play Opportunities Program in Improving Parent and Child Outcomes for Underserved Families.
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:
- 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].
- Child's playfulness behavior as measured during 15-minute video-recorded joint play activity at home using the Test of Playfulness [ToP].
- Child's psychological adjustment as measured by the Strength and Difficulties Questionnaire [SDQ].
- Parent's perception and satisfaction from their involvement in the program as measured through open-ended questions.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The Promoting Health Through Play Opportunities program (Halperin et al., 2021; Waldman-Levi & Halperin, 2022) is a strength-based intervention that provides tools to help parents become change agents in their child's life through the promotion of healthy play opportunities within the family context.
This research project aims to enhance children's development through playful interactions with their parents.
The investigators speculate that the program will be effective in improving parent and child joint play experience and child's social-emotional functioning.
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Professor, Director of Scholarship and Research
- Phone Number: 646.592.4765
- Email: amiya.waldmanlevi@yu.edu
Study Contact Backup
- Name: Lola Halperin, EdD
- Email: halperinl@sacredheart.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10453
- Recruiting
- Head Start
-
Contact:
- Amiya Waldman-Levi, PhD
- Phone Number: 646.592.4765
- Email: amiya.waldmanlevi@yu.edu
-
Contact:
- Danette L Brown, PhD
- Phone Number: (718) 901-0140
-
Contact:
- Amiya Waldman-Levi, PhD
-
Contact:
- Danette L Brown, PhD
-
Contact:
- Lola Halperin, EdD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Promoting Health Through Play English version
Parent online group sessions- English version consisting of five 45-minute-long parent group online sessions.
In addition, each parent-child dyad will receive, one 30-minute-long online guided play session with OTS/OT.
|
The intervention will consist of two parts: (a) five 45-minute-long parent group online sessions; and (b) one 30-minute long online guided play session with OTS/OT.The training will consist of asynchronous module and PowerPoint presentations followed by role play and discussions.
Other Names:
|
|
Other: Promoting Health Through Play Spanish version
Parent online group sessions- Spanish version consisting of five 45-minute-long parent group online sessions.
In addition, each parent-child dyad will receive, one 30-minute-long online guided play session with OTS/OT.
|
The intervention will consist of two parts: (a) five 45-minute-long parent group online sessions; and (b) one 30-minute long online guided play session with OTS/OT.The training will consist of asynchronous module and PowerPoint presentations followed by role play and discussions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire. Goodman R. (1997). The Strengths and Difficulties Questionnaire: A research note. 38(5), 581-586. doi:10.1111/j.1469-7610.1997.tb01545.x
Time Frame: through study completion, an average of 6 weeks
|
The Strengths and Difficulties Questionnaire assesses child's psychological adjustment.
It contains 25 items measured on a scale ranging from 0 (no difficulty) to 2 (severe difficulty).
|
through study completion, an average of 6 weeks
|
|
Parent/Caregiver Support of Children Playfulness (PC-SCP). Waldman-Levi, A., & Bundy, A. (2023). Parent/Caregiver Support of Children Playfulness (PC-SCP). AOTA Press.
Time Frame: through study completion, an average of 6 weeks
|
The PC-SCP assesses how parents or primary caregivers support children's ability to play.
It is based on a 15-minute video-recorded observation of a parent-child joint play and contains 16 items.
Scores range from 0 (low level of parent support of child's play or playfulness) to 3 (high level of parent support of child's play or playfulness).
|
through study completion, an average of 6 weeks
|
|
Test of Playfulness. Skard, G., & Bundy, A. C. (2008). Test of Playfulness. In L. D. Parham & L. S. Fazio (Eds.), Play in occupational therapy for children (2nd ed., pp. 71-93). St. Louis, MO: Mosby, Inc
Time Frame: through study completion, an average of 6 weeks
|
The ToP assesses children's ability to play in a playful manner.
It is observed during video-recorded 15-minute play and contains 30 items.
Scores range from 0 (low level of child's playfulness behavior) to 3 (high level of child's playfulness behavior).
|
through study completion, an average of 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent post program interview
Time Frame: 6 weeks
|
Semi-structured recorded interview
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2022
Primary Completion (Estimated)
December 5, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
September 13, 2024
First Submitted That Met QC Criteria
January 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 13, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 20226278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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