Clinical trial NCT06625255: Promoting Playfulness
Official title: Promoting Playfulness: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Developmental Delay (Disorder)
Keywords: play
playfulness
parent education
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
Collaborators: name: Yeshiva University
First posted: 2024-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parental Sense of Competence (PSOC-R)
timeFrame: At the completion of two weeks
measure: Parent/Caregiver's View of Supporting Children's Play and Playfulness
timeFrame: At the completion of two weeks
measure: Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
timeFrame: At the completion of two weeks
Secondary outcomes:
measure: Parent post program open-ended questions
timeFrame: At the completion of two weeks
measure: Parent pre program open-ended questions
timeFrame: At enrollment
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Little Eagles Learning Center
state: Florida
Study officials:
affiliation: Associate Professor
name: Sarah Fabrizi, PhD OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeshiva University - Professor
name: AMiya Waldman-Levi, PhD OTR/L
role: PRINCIPAL_INVESTIGATOR
References: