Recruiting
Early Phase 1

Observational Study

Sponsor:

Florida Gulf Coast University

Code:

NCT06625255

Conditions

Developmental Delay (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Parent Education - Promoting Playfulness

Study Details

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)

Study ID

NCT06625255

Start date

Sep 16, 2024

Status verified date

Oct, 2024

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Waitlist control

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

Interventions

Parent Education - Promoting Playfulness

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

Primary outcome measure

  • Parental Sense of Competence (PSOC-R) [ Time Frame: 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 ]
  • Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) [ Time Frame: At the completion of two weeks ]

Central Contacts and Locations

Central contacts

Sarah E Fabrizi, PhD OTR/L

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

Sherry Alexander

(239) 590-7522sralexander@fgcu.edu

Locations

Little Eagles Learning Center

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Chantelle Yamrick

2395907749cyamrick@fgcu.edu

Sarah Fabrizi

239-822-2292sfabrizi@fgcu.edu

More Information

Sponsor

Florida Gulf Coast University

Last update posted

Oct 4, 2024

Last verified

Oct, 2024

Keywords

  • play
  • playfulness
  • parent education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida Gulf Coast University on 2024-10-04.