Improving access to autism services for Black toddlers through virtual support
Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach
This study tests if virtual support can help Black toddlers with autism get the services they need faster and improve their development compared to families who only receive standard information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 1 Year to 99 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Carrboro, North Carolina) |
| Trial ID | NCT06291246 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of telehealth-based Family Navigation in reducing the time it takes for Black toddlers under four years old to enroll in community-based autism interventions after their diagnosis. Caregivers will receive four individual sessions with a trained navigator to help them identify and access recommended early intervention services. The study compares outcomes between families receiving Family Navigation and those receiving standard educational materials. Key outcomes include the time to intervention initiation, developmental progress at 18 months post-diagnosis, and caregiver well-being.
Who should consider this trial
Good fit: Ideal candidates are Black toddlers under 48 months with a new autism diagnosis and their caregivers residing in Georgia or North Carolina.
Not a fit: Patients who do not have access to a telephone or internet for virtual sessions or whose autism diagnosis has been ruled out will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce delays in accessing autism interventions for Black toddlers, leading to improved developmental outcomes.
How similar studies have performed: While the specific approach of telehealth Family Navigation is novel, similar studies have shown promise in improving access to care for underserved populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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.
Where this trial is running
Carrboro, North Carolina
- Carolina Institute for Developmental Disabilities — Carrboro, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kelly Caravella, PhD — UNC
- Study coordinator: Kelly Caravella, PhD
- Email: kelly_caravella@med.unc.edu
- Phone: 2035244349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.