NCT06781840

Brief Summary

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. 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. 2.Child's playfulness behavior as measured during 15-minute video-recorded joint play activity at home using the Test of Playfulness \[ToP\].
  3. 3.Child's psychological adjustment as measured by the Strength and Difficulties Questionnaire \[SDQ\].
  4. 4.Parent's perception and satisfaction from their involvement in the program as measured through open-ended questions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 17, 2025

Status Verified

August 1, 2024

Enrollment Period

3.9 years

First QC Date

September 13, 2024

Last Update Submit

January 13, 2025

Conditions

Keywords

playplayfulnessparent-group educational training

Outcome Measures

Primary Outcomes (3)

  • 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

    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.

    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

    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 Outcomes (1)

  • Parent post program interview

    6 weeks

Study Arms (2)

Promoting Health Through Play English version

EXPERIMENTAL

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

Promoting Health Through Play Spanish version

OTHER

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

Interventions

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.

Also known as: Promoting Health Through Play Opportunities program
Promoting Health Through Play English versionPromoting Health Through Play Spanish version

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Head Start

New York, New York, 10453, United States

RECRUITING

Central Study Contacts

Clinical Professor, Director of Scholarship and Research

CONTACT

Lola Halperin, EdD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 2 groups: One for English speaking parents and the other for Spanish speaking parents.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

January 17, 2025

Study Start

January 21, 2022

Primary Completion

December 5, 2025

Study Completion

December 30, 2025

Last Updated

January 17, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations