Helping rural toddlers on the autism spectrum start services sooner
Official title: Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
Run by University of North Carolina, Chapel Hill · NCT07086781 · Data updated 2026-11-12
This project will test whether virtual Family Navigation helps toddlers under 4 in rural North Carolina with a new or pending autism diagnosis start community early-intervention services sooner and improves child development and caregiver well-being.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 99 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Carrboro, North Carolina) |
| Status | Recruiting |
| Started | July 19, 2025 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 29, 2025 |
| Trial ID | NCT07086781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Toddlers under 48 months with a new or pending autism diagnosis who live in one of North Carolina's 78 rural counties and have an English-speaking caregiver aged 18 or older.
✕Probably not a fit
Families without reliable phone or internet access, children whose autism diagnosis is ruled out, or those living outside the specified rural North Carolina counties are unlikely to benefit from this remote navigation approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional program compares families who receive four individualized virtual Family Navigation sessions with families who receive standard educational materials. Trained navigators will work with caregivers by phone or Zoom to identify recommended early intervention services and support enrollment. Primary outcomes include time (days) to start community-based autism intervention, child developmental measures at 18 months post-diagnosis, and caregiver well-being. The study enrolls toddlers under 48 months living in one of North Carolina's 78 rural counties and requires caregiver participation in English.
Why it matters
Potential benefit: If successful, virtual Family Navigation could help rural families begin early autism services faster, potentially improving toddlers' developmental outcomes and reducing caregiver stress.
How similar studies have gone: Patient-navigation and telehealth programs have improved access and service initiation in other pediatric settings, but telehealth family navigation specifically for rural toddlers with autism is relatively novel with limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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 it's running
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Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Kelly Caravella, PhD — Carolina Institute for Developmental Disabilities
- Study coordinator: Kelly E Caravella, PhD
- Email: kelly_caravella@med.unc.edu
- Phone: 203-524-4349
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.