Child DevelopmentNCT06781840
Promoting Health Through Play Program: Improving Parent and Child Outcomes
A study testing Playing Playfully to Overcome Adversity in people with Child Development and Parenting, run by Yeshiva University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Parenting
- What is being tested?
- Playing Playfully to Overcome Adversity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Clinical Professor, Director of Scholarship and Research contact
Lola Halperin, EdD contact
United States1 site, 1 recruiting
- Recruiting
Head Start
New York, New York, 10453
Amiya Waldman-Levi, PhD, 646.592.4765, amiya.waldmanlevi@yu.edu
Danette L Brown, PhD, (718) 901-0140
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Development, Parenting
- Being tested
- Playing Playfully to Overcome Adversity
- Keywords
- play, playfulness, parent-group educational training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing Playfully to Overcome AdversityBehavioural
Also called Promoting Health Through Play Opportunities program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Playing Playfully to Overcome Adversity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: through study completion, an average of 6 weeks
Secondary outcomes (1)
Parent post program interview
Semi-structured recorded interview
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start21 Jan 2022
- Primary completion5 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups: One for English speaking parents and the other for Spanish speaking parents.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeshiva University
- Sponsor type
- University, hospital or other
- Collaborators
- Head Start
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781840
- Sponsor's protocol ID
- 20226278
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of the Promoting Health Through Play Opportunities Program in Improving Parent and Child Outcomes for Underserved Families.
- ClinicalTrials.gov ID
- NCT06781840
- Acronym / sponsor ID
- 20226278
- Conditions
- Child Development, Parenting
- Keywords
- play, playfulness, parent-group educational training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yeshiva UniversityUniversity, hospital or other
- Collaborators
- Head Start
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 5 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups: One for English speaking parents and the other for Spanish speaking parents.
| Arm | Type | Receives |
|---|---|---|
| Promoting Health Through Play English version | Experimental | Behavioral: Playing Playfully to Overcome AdversityParent 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. |
| Promoting Health Through Play Spanish version | Other | Behavioral: Playing Playfully to Overcome AdversityParent 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Playing Playfully to Overcome AdversityAlso: Promoting Health Through Play Opportunities programThe 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. | Behavioural | Promoting Health Through Play English version, Promoting Health Through Play Spanish version |
Primary outcome
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).
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).
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).
1 secondary outcome
Parent post program interview
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Professor, Director of Scholarship and Research contact
Lola Halperin, EdD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Playing Playfully to Overcome Adversity in people with Child Development and Parenting, run by Yeshiva University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Professor, Director of Scholarship and Research (646.592.4765, amiya.waldmanlevi@yu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.