Resources for Optimizing Outcomes in Toddlers on the Spectrum

Part of paid clinical trials in Carrboro, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07086781
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Virtual Family Navigation — BEHAVIORAL
    Participants randomized to the Family Navigation condition will receive up to 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.
  • Educational Materials — BEHAVIORAL
    The comparison condition ("Educational Materials") consists of providing the participant's caregivers information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations. Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.

Study Details

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.

Key Dates

Start date
Jul 19, 2025
Status verified
Oct 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Family Navigation
    Participants randomized to the Family Navigation condition will receive up to 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.
  • Active Comparator: Educational Materials
    The comparison condition ("Educational Materials") consists of providing the child's caregivers with information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations). Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.

Primary Outcome Measure

Time to initiation of autism specific intervention [ Time Frame: Diagnosis to 18 months post ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolina Institute for Developmental DisabilitiesCarrboroNorth Carolina27510
Kelly Caravella, PhD
[email protected]
2035244349

Find similar trials in Carrboro, NC

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Carolina Institute for Developmental Disabilities· Carrboro, NC

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