Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to initiation of autism specific intervention
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Time to initiation of autism specific intervention
Time Frame: Diagnosis to 18 months post
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).
Secondary Outcomes
- Caregiver Well-Being Score(6 months post diagnosis)
- Change in Raw Scores on Visual Reception domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Expressive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Receptive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Fine Motor domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains(Baseline and 18 months post diagnosis)