Promoting Playfulness

October 2, 2024 updated by: Dr. Sarah Fabrizi, Florida Gulf Coast University

Promoting Playfulness: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience

Health inequalities, social isolation, and family adversity impact a child's development. Play is the context for child development in all areas. A parent's ability to support children at play while being playful contributes to their psychological adjustment. The proposed tier 1, strengths-based educational program for parents of children aged 2 to 5 years with and without disabilities combines elements of a play-based approach and tips on effective parenting to support children's development by equipping parents with knowledge and empowering them to become change agents in their children's lives.

Study Overview

Detailed Description

Parents will be recruited through a convenience sampling method to either an intervention group delivered online or a control waitlist group. Parents will be asked to complete a set of questionnaires online to assess the proposed programs effectiveness. Data analysis will explore between and within group differences in parental sense of competency, parental stress, child's behavior, and ability to support child's play. Qualitative data will be collected through online open-ended questions and sessions' transcript which will be analyzed to identify benefits. The project will produce tangible outcomes that will contribute to fostering the resilience of families with young children.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

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: Sarah E Fabrizi, PhD OTR/L
  • Phone Number: 1-239-590-1854
  • Email: sfabrizi@fgcu.edu

Study Contact Backup

Study Locations

    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Little Eagles Learning Center
        • Contact:
        • Contact:
        • Contact:
          • Sarah Fabrizi, PhD OTR/L

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parent of a child aged 2 to 5 with no major disability (sensory, intellectual disability, neuromuscular disability).
  • Can commit to participating in two online sessions;
  • Has a device with a stable internet connection; and
  • Communicates with high school-level English.

Exclusion Criteria:

• Parents with children who have severe behavioral or sensory issues.

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: Intervention - Parent Education
Parents will participate in 2, 45 minute virtual training sessions with information and question and anwsers. Each session will provide information about child development and parent advocacy and stressors. Play as the means for promoting healthy development will be emphasized.
Parents will participate in 2, 45 minute parent education sessions promoting playfulness through information about child development, parent stressors, and parent advocacy.
No Intervention: Waitlist control
Parents will have family life as usual with no education sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time Frame: At the completion of two weeks
Parental self-report assessing a child's behavior, 25 items rated on a scale ranging from 0, not true, to 2, certainly true.
At the completion of two weeks
Parental Sense of Competence (PSOC-R)
Time Frame: At the completion of two weeks
The Parenting Sense of Competence scale (PSOC-R) is a self-report measure that aims to assesses one's perceived efficacy and satisfaction with parenting. 16 items are scored on a scale of 1-6, 1 strongly disagree to 6 strongly agree.
At the completion of two weeks
Parent/Caregiver's View of Supporting Children's Play and Playfulness
Time Frame: At the completion of two weeks
11 items scored on a scale of 0, not agree, to 2, strongly agree, to describe parent's perception of a child's play and joint play.
At the completion of two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent post program open-ended questions
Time Frame: At the completion of two weeks

A set of three open-ended questions about parents experience and takeaways after participation in the program.

Can the participants tell the investigators about participant experience with group training? Why do the participants think it worked well and what did not work well for the participants? How do the participants perceive play time with your child/ren now? Has anything changed after the program?

At the completion of two weeks
Parent pre program open-ended questions
Time Frame: At enrollment

A set of three questions regarding parent's expectations of the program.

The investigators would like to learn more about your thoughts and experiences and will appreciate if the participants could answer the below questions What role does play have in children's development? Do the participants have a designated time that you play with your child? can the participants tell us about it.

What do the participants expect to gain from these information sessions?

At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Sarah Fabrizi, PhD OTR/L, Associate professor
  • Principal Investigator: AMiya Waldman-Levi, PhD OTR/L, Yeshiva University - Professor

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)

September 16, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Protocol ID # 2024-85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share participant data.

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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