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RECRUITING
NCT07086781
NA

Resources for Optimizing Outcomes in Toddlers on the Spectrum

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

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.

Official title: Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study

Key Details

Gender

All

Age Range

1 Year - 99 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-07-19

Completion Date

2028-07

Last Updated

2025-10-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

Virtual Family Navigation

Participants randomized to the Family Navigation condition will receive up to 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.

BEHAVIORAL

Educational Materials

The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.

Locations (1)

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina, United States