- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06625255
Promoting Playfulness
Promoting Playfulness: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Sarah E Fabrizi, PhD OTR/L
- Phone Number: 1-239-590-1854
- Email: sfabrizi@fgcu.edu
Study Contact Backup
- Name: Sherry Alexander
- Phone Number: (239) 590-7522
- Email: sralexander@fgcu.edu
Study Locations
-
-
Florida
-
Fort Myers, Florida, United States, 33908
- Recruiting
- Little Eagles Learning Center
-
Contact:
- Chantelle Yamrick
- Phone Number: 2395907749
- Email: cyamrick@fgcu.edu
-
Contact:
- Sarah Fabrizi
- Phone Number: 239-822-2292
- Email: sfabrizi@fgcu.edu
-
Contact:
- Sarah Fabrizi, PhD OTR/L
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Protocol ID # 2024-85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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