| NCT ID | NCT06625255 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Florida Gulf Coast University |
| Condition | Developmental Delay (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-09-16 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sarah Fabrizi, PhD OTR/L
PRINCIPAL INVESTIGATOR
Associate Professor
Frequently Asked Questions
Who can join the NCT06625255 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Developmental Delay (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06625255 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06625255 currently recruiting?
Yes, NCT06625255 is actively recruiting participants. Contact the research team at sfabrizi@fgcu.edu for enrollment information.
Where is the NCT06625255 trial being conducted?
This trial is being conducted at Fort Myers, United States.
Who is sponsoring the NCT06625255 clinical trial?
NCT06625255 is sponsored by Florida Gulf Coast University. The principal investigator is Sarah Fabrizi, PhD OTR/L at Associate Professor. The trial plans to enroll 40 participants.