Resources for Optimizing Outcomes in Toddlers on the Spectrum

The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for toddlers under the age of 4 living in Rural NC after their initial diagnosis of autism. The main questions it aims to answer are: Does Family Navigation decrease the time to initiation of intervention for rural toddlers with autism? Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism? Does Family Navigation improve caregiver well-being? Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom. Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.

NCT Number	NCT07086781
Lead Sponsor	University of North Carolina, Chapel Hill Collaborators: Foundation of Hope, North Carolina
Conditions	Autism Spectrum Disorder
Enrollment	60 participants
Start Date	2025-07-19
Primary Completion	2028-07 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2025-10-29