Resources for Optimizing Outcomes in Toddlers on the Spectrum
NCT ID: NCT07086781
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-19
2028-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Virtual 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.
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.
Educational Materials
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.
Interventions
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Virtual 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.
Educational Materials
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Diagnosis of autism spectrum disorder is ruled out in the child.
1 Year
99 Years
ALL
No
Sponsors
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The Foundation of Hope for Research and Treatment of Mental Illness
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Kelly Caravella, PhD
Role: PRINCIPAL_INVESTIGATOR
Carolina Institute for Developmental Disabilities
Locations
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Carolina Institute for Developmental Disabilities
Carrboro, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-1164
Identifier Type: -
Identifier Source: org_study_id
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