NCT06291246Terminated
Expediting Access to Services for Equity
Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
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 Black toddlers under the age of 4 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 Black 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)
- Terminated
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 26 Feb 2024
- Start date
- 19 Nov 2024
- Primary completion date
- 7 Jul 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Autism
- NCT number
- NCT06291246
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, or who are waiting for a diagnosis of autism AND their caregiver.
- Live in Georgia or North Carolina
- Caregiver must be over the age of 18
- Their child with autism must identify as Black/African-American
- 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. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Carolina Institute for Developmental Disabilities | Carrboro | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.