Expediting Access to Services for Equity (EASE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Virtual Family Navigation; Behavioral: Educational Materials

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Carrboro, North Carolina, United States, 27510
      • Carolina Institute for Developmental Disabilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Child's Adaptive Functioning Score	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.	18 months post enrollment

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Kelly Caravella, PhD, UNC

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 23-1823; K12TR004416-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina.
• IPD Sharing Time Frame: 9 to 36 months following publication.
• IPD Sharing Access Criteria: Investigator must have approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No