Back to Trials
NCT07086781NARecruiting

Resources for Optimizing Outcomes in Toddlers on the Spectrum

University of North Carolina, Chapel Hill

Start Date

7/19/2025

Completion Date

7/1/2028

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.

Eligibility Criteria

Age Range: 1 years to 99 years

Inclusion Criteria: * Children up to 48 months who have a new diagnosis of autism (within the last month) or who are waiting for a diagnosis of autism AND their caregiver. * Live in North Carolina, in one of the 78 rural counties. * Caregiver must be over the age of 18 * The caregiver must speak conversationally fluent English. Exclusion Criteria: * No access to a telephone or internet connection for phone calls or video conferencing. * Diagnosis of autism spectrum disorder is ruled out in the child.

Interventions

BEHAVIORAL

Virtual Family Navigation

BEHAVIORAL

Educational Materials

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Autism Spectrum Disorder

Locations

Carolina Institute for Developmental Disabilities

Carrboro, North Carolina 27510

United States