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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Carolina Institute for Developmental Disabilities
RECRUITING
Carrboro
Contact Information
Primary
Kelly E Caravella, PhD
kelly_caravella@med.unc.edu
203-524-4349
Time Frame
Start Date: 2025-07-19
Estimated Completion Date: 2028-07
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Active_comparator: Educational Materials
The comparison condition (Educational Materials) consists of providing the child's caregivers with 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.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: The Foundation of Hope for Research and Treatment of Mental Illness

This content was sourced from clinicaltrials.gov