Helping rural toddlers on the autism spectrum start services sooner
Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (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 | NCT07086781 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 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 — Carolina Institute for Developmental Disabilities
- Study coordinator: Kelly E Caravella, PhD
- Email: kelly_caravella@med.unc.edu
- Phone: 203-524-4349
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.