NCT07086781Recruiting
Resources for Optimizing Outcomes in Toddlers on the Spectrum
Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
Source: ClinicalTrials.gov · Last updated 29 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Jul 2025
- Start date
- 19 Jul 2025
- Primary completion date
- Jul 2028
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Autism
- NCT number
- NCT07086781
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 19 Jul 2025 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of autism spectrum disorder is ruled out in the child.
Other
- No access to a telephone or internet connection for phone calls or video conferencing.
Who the study is looking for
- 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.
Age in the registry: 1 year to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolina Institute for Developmental Disabilities Coordinator of this site? Confirm its status | Carrboro | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.