NCT07086781 Resources for Optimizing Outcomes in Toddlers on the Spectrum
| NCT ID | NCT07086781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-19 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-19 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Kelly Caravella, PhD
PRINCIPAL INVESTIGATOR
Carolina Institute for Developmental Disabilities
Frequently Asked Questions
Who can join the NCT07086781 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 99 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07086781 currently recruiting?
Yes, NCT07086781 is actively recruiting participants. Contact the research team at kelly_caravella@med.unc.edu for enrollment information.
Where is the NCT07086781 trial being conducted?
This trial is being conducted at Carrboro, United States.
Who is sponsoring the NCT07086781 clinical trial?
NCT07086781 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Kelly Caravella, PhD at Carolina Institute for Developmental Disabilities. The trial plans to enroll 60 participants.