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NCT07086781 · ClinicalTrials.gov registry record · NA
Resources for Optimizing Outcomes in Toddlers on the Spectrum
A NA study of Autism Spectrum Disorder, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07086781: Recruiting NA study of Autism Spectrum Disorder, sponsored by University of North Carolina, Chapel Hill.
NCT07086781 is a NA study of Autism Spectrum Disorder that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 60 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07086781, a NA study of Autism Spectrum Disorder, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The date of initiation (date 1) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 2). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1).
Conditions Studied
Interventions
- BEHAVIORAL Educational Materials
- BEHAVIORAL Virtual Family Navigation
Study Locations (1)
North Carolina
- Carolina Institute for Developmental Disabilities - Carrboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-07-19 |
| Est. Completion | 2028-07 |
| Phase | NA |
What NCT07086781 shows while recruiting
NCT07086781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Educational Materials is the first listed.
NCT07086781 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07086781 about?
NCT07086781 is a clinical study titled "Resources for Optimizing Outcomes in Toddlers on the Spectrum". 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 aim...
What is the current status of trial NCT07086781?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-07-19. Estimated completion is 2028-07.
What conditions does trial NCT07086781 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT07086781?
The interventions under investigation include: Educational Materials (BEHAVIORAL), Virtual Family Navigation (BEHAVIORAL).
Who is sponsoring clinical trial NCT07086781?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07086781 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07086781's enrollment target sits among peer trials
60 118th of 224 higher than 95 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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