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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Clinical Professor, Director of Scholarship and Research
  • Phone Number: 646.592.4765
  • Email: amiya.waldmanlevi@yu.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10453
        • Recruiting
        • Head Start
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Playing Playfully to Overcome Adversity
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:
  • Promoting Health Through Play Opportunities program
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.
Behavioral: Playing Playfully to Overcome Adversity
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:
  • Promoting Health Through Play Opportunities program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeshiva University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Head Start

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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