Actively Recruiting
Resources for Optimizing Outcomes in Toddlers on the Spectrum
Led by University of North Carolina, Chapel Hill · Updated on 2025-10-29
60
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
F
Foundation of Hope, North Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Resources for Optimizing Outcomes in Toddlers on the Spectrum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children up to 48 months old with a new autism diagnosis within the last month or waiting for a diagnosis and their caregiver
- Living in one of the 78 rural counties in North Carolina
- Caregiver is over 18 years old
- Caregiver speaks conversational English
You will not qualify if you...
- No access to a telephone or internet for phone calls or video conferencing
- Child's autism spectrum disorder diagnosis is ruled out
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, United States, 27510
Actively Recruiting
Research Team
K
Kelly E Caravella, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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