Resources for Optimizing Outcomes in Toddlers on the Spectrum (NCT07086781)
Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Carolina Institute for Developmental Disabilities — Carrboro, North Carolina
Age range: 1 Year to 99 Years
🧪 Interventions in This Study
- Virtual Family Navigation (BEHAVIORAL)
- Educational Materials (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Carolina Institute for Developmental Disabilities — Carrboro, North Carolina
📞 Contact the Study Coordinator
Phone: (203) 524-4349
Email: kelly_caravella@med.unc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Autism Spectrum Disorder
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- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder — New Haven, Connecticut
- PRISM Intervention Study — Los Angeles, California
- ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) — Dothan, Alabama
- MTT for Children With ASD Who Have Gastrointestinal Disorders — Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.