Promoting Playfulness

NCT06625255 | Recruiting Early Phase 1

• 1 other identifier: Protocol ID # 2024-85
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Delay (Disorder)

Keywords

play; playfulness; parent education

Outcome Measures

Primary Outcomes (3)

• Parental Sense of Competence (PSOC-R)

  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

  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

• Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)

  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

Secondary Outcomes (2)

• Parent post program open-ended questions

  At the completion of two weeks

• Parent pre program open-ended questions

  At enrollment

Study Arms (2)

Intervention - Parent Education

EXPERIMENTAL

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.

Behavioral: Parent Education - Promoting Playfulness

Waitlist control

NO INTERVENTION

Parents will have family life as usual with no education sessions.

Interventions

Parent Education - Promoting Playfulness BEHAVIORAL

Parents will participate in 2, 45 minute parent education sessions promoting playfulness through information about child development, parent stressors, and parent advocacy.

Intervention - Parent Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Florida Gulf Coast University: lead
• Yeshiva University: collaborator

Study Sites (1)

Little Eagles Learning Center

Fort Myers, Florida, 33908, United States

RECRUITING

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sarah Fabrizi, PhD OTR/L

  Associate Professor

  PRINCIPAL INVESTIGATOR

• AMiya Waldman-Levi, PhD OTR/L

  Yeshiva University - Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Fabrizi, PhD OTR/L

CONTACT

1-239-590-1854; sfabrizi@fgcu.edu

Sherry Alexander

CONTACT

(239) 590-7522; sralexander@fgcu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Flyers will be distributed, and participants will be able to contact the PI via email and use the QR code to complete the screening for eligibility. Eligibility screening will be conducted online by the prospective participant answering the following questions: (1) do you have a child aged 2 to 5? (b) do you speak and read English? and (c) can you attend two online sessions via Zoom where the content be provided via PowerPoint slides? Next, eligible participants will be asked to provide their email address and will then receive a link to complete the online consent procedure and pre-test through Qualtrics along with an assigned code to connect their pre-and-post data. The intervention group will begin when there are at least five eligible parents who consented. New enrolled parents will be waitlisted for two to three weeks after they completed the pre-program questionnaires, then after a two-week wait period they will be asked to complete the post-test Qualtrics survey 3.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)