Expediting Access to Services for Equity (EASE)

Autism Spectrum Disorder Clinical Trial

— EASE  

Official title:

Expediting Enrollment Into Autism-specific Intervention for Black Toddlers: A Telehealth-based Family Navigation Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06291246
• Other study ID #: 23-1823
• Secondary ID: K12TR004416-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Kelly Caravella, PhD
• Phone: 2035244349
• Email: kelly_caravella[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 3 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Caregiver of a child with a clinical diagnosis of autism spectrum disorder
• Over the age of 18
• Their child with autism must be Black/African-American
• Speak conversationally fluent English.

Exclusion Criteria:

• No access to a telephone or internet connection for phone calls or video conferencing.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Virtual Family Navigation
4 sessions of 1:1 virtual family navigation delivered via phone or video call.
• Educational Materials
Participants will receive individualized recommendations for early intervention for their child at the time of the diagnosis of autism spectrum disorder.

Locations

Country	Name	City	State
United States	Carolina Institute for Developmental Disabilities	Carrboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to initiation of autism specific intervention	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).	From enrollment to 6 months post.
Secondary	Caregiver Well-Being Score	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).	6 months post enrollment
Secondary	Child's Developmental Functioning Score	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.	18 months post enrollment
Secondary	Child's Adaptive Functioning Score	The Adaptive Behavior Composite (ABC) from the Vineland Adaptive Behavior Scales, Third Edition (VABS-3) will be used to measure adaptive functioning. The VABS-3 assesses 4 domains of adaptive behavior, including communication, daily living skills, socialization, and motor skills. The Adaptive Behavior Composite (ABC) 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.	18 months post enrollment
Secondary	Appropriateness of Intervention Score	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.	6 months after enrollment
Secondary	Feasibility of Intervention Score	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.	6 months after enrollment
Secondary	Acceptability of Intervention Score	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.	6 months after enrollment