Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

Summary

The goal of this clinical trial is to test whether the Function-Based Elopement Treatment (FBET) can reduce elopement in children aged 4-12 with autism spectrum disorder (ASD), and to assess its feasibility in community-based Applied Behavior Analysis (ABA) clinics. Researchers will evaluate FBET in a single-arm open-label trial in one clinic, followed by a comparison of FBET to treatment as usual (TAU) across at least six ABA clinics to evaluate effectiveness and implementation.

The main questions it aims to answer are:

* Is it feasible to use FBET in community-based ABA clinics?
* Does FBET reduce elopement?
* Does FBET lead to greater clinical improvement?

Participants will:

* Receive 12 sessions of FBET over 20 weeks with trained BCBAs or receive treatment as usual
* Complete caregiver assessments at baseline and endpoint
* Engage in caregiver training and practice treatment between appointments

Conditions

• Autism Spectrum Disorder

Interventions

BEHAVIORAL

Function-Based Elopement Treatment

FBET is a structured, caregiver-implemented behavioral intervention targeting elopement in children. It includes: * Psychoeducation and Behavioral Assessment-caregivers receive training on elopement, behavioral principles, and assessment strategies * Functional Analysis Coaching-therapists guide caregivers through a latency-based functional analysis to identify the function of elopement * Individualized Treatment Implementation-caregivers apply a function-based plan using differential reinforcement, providing preferred items/activities contingent on safe behavior * Treatment Modification-therapists support caregivers in adjusting the plan based on child's response. There will be 12 2-hour, caregiver-mediated sessions across 20 weeks Caregivers also learn safety and prevention strategies, including the use of resources like the Big Red Safety Toolkit.

BEHAVIORAL

Treatment as Usual

TAU consists of ongoing Applied Behavior Analysis (ABA) services, including caregiver training as it normally exists, provided by the family's Board Certified Behavior Analyst (BCBA), independent of the study protocol. The BCBA determines session frequency, content, and focus based on clinical judgment and the child's individual needs. Topics may include skill acquisition, behavior reduction (including elopement), or other areas deemed relevant to the child's care. The research team does not influence or standardize the TAU content, but will monitor and document the services delivered for descriptive and comparative purposes

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Mindy Scheithauer · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2028-10-31

Completion

2028-10-31

Countries

• United States

Study Locations