Expediting Access to Services for Equity (EASE)
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: Educational MaterialsBehavioral: Virtual Family Navigation
- Registration Number
- NCT06291246
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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 Black toddlers under the age of 4 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 Black 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 86
- Children up to 48 months who have a new diagnosis of autism, or who are waiting for a diagnosis of autism AND their caregiver.
- Live in Georgia or North Carolina
- Caregiver must be over the age of 18
- Their child with autism must identify as Black/African-American
- Speak conversationally fluent English.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educational Materials Educational Materials The comparison condition ("Educational Materials") consists of providing the participant's caregivers with individualized recommendations for intervention for their child at the time of the diagnosis of autism spectrum disorder. Family Navigation 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.
- Primary Outcome Measures
Name Time Method Time to initiation of autism specific intervention From enrollment to 6 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 Outcome Measures
Name Time Method Caregiver Well-Being Score 6 months post enrollment Scores on the General Well-Being Schedule will be used to measure caregiver well-being. Total scores range from 0-110. Higher scores are indicative of more positive well-being. There are 3 proposed scoring cut-points: 0-60 reflects "severe distress", 61-72 reflects "moderate distress", and 73-110 reflects "positive well-being).
Child's Developmental Functioning Score 18 months post enrollment The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning. The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger performance.
Child's Adaptive Functioning Score 18 months post enrollment The Adaptive Behavior Assessment Scale, Third Edition (ABAS-3) will be used to measure adaptive functioning. The ABAS-3 assesses 3 domains of adaptive behavior, including Conceptual, Social, and Practical. The General Adaptive Composite (GAC) is a composite score derived from the 4 domains. It has a mean of 100 and a standard deviation of 15. Higher scores indicate stronger adaptive behavior skills.
Appropriateness of Intervention Score 6 months after enrollment The Intervention Appropriateness Measure (IAM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's appropriateness. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Feasibility of Intervention Score 6 months after enrollment The Feasibility of Intervention Measure (FIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's feasibility. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Acceptability of Intervention Score 6 months after enrollment The Acceptability of Intervention Measure (AIM) is a 4 question survey that assesses a participant's experience with or thoughts about the intervention's acceptability. A scaled score can be created by averaging the item-level responses. Scaled score values range from 1 to 5. Cut-off scores or norms for interpretation are not yet available; however, higher scores indicate greater appropriateness.
Trial Locations
- Locations (1)
Carolina Institute for Developmental Disabilities
🇺🇸Carrboro, North Carolina, United States