Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

Not Applicable

Not yet recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT07194083
• Lead Sponsor: Emory University

Brief 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

Detailed Description

Autism Spectrum Disorder (ASD) affects approximately 2.8% of children, or 1 in 36, and is characterized by delayed social communication, restricted interests, and repetitive behaviors. Many children with ASD also exhibit externalizing behaviors such as aggression, self-injury, property destruction, and elopement-defined as leaving supervision without permission. Elopement is a particularly dangerous and stressful behavior, reported as a concern by 35-49% of parents of autistic children. It can occur in various settings, such as bolting in public places or wandering from home, and has been linked to serious injury in nearly 59% of cases. Despite the effectiveness of applied behavior analysis (ABA) strategies in reducing elopement, access to evidence-based treatments (EBTs) remains limited.

The availability of ABA services has grown due to insurance mandates in all 50 states and a significant increase in Board Certified Behavior Analysts (BCBAs), with an estimated 40% of autistic children accessing ABA. However, many BCBAs lack specific training in elopement interventions, such as functional analyses, and only about half provide regular caregiver training. Research has traditionally relied on small-scale studies with limited generalizability and minimal caregiver involvement, creating barriers to widespread implementation.

To address these gaps, researchers developed the Function-Based Elopement Treatment (FBET), a structured, caregiver-mediated ABA intervention designed for real-world settings. FBET includes detailed protocols, decision trees, caregiver scripts, and a workbook to support BCBA implementation and caregiver engagement. In a randomized efficacy trial involving 76 children with ASD and elopement, FBET demonstrated significant improvements over a parent education program (PEP) in reducing elopement severity and frequency, increasing safety measures, and achieving better overall outcomes as rated by independent evaluators.

While FBET shows promise, its effectiveness was tested in a specialized clinic with experienced BCBAs under close supervision. It remains uncertain whether similar results can be replicated in community settings where providers may have less training and support. Nonetheless, FBET represents a meaningful step toward expanding access to effective elopement interventions for children with ASD.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-10-01
• Primary Completion: 2028-10
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Child participant:

• Boys and girls ages > 4 to < 12 years
• Autism Spectrum Disorder (ASD) diagnosis by history
• Presence of elopement as an important caregiver concern - elopement occurring regularly for at least 3 months.
• At least one primary caregiver can speak and understand English.

Exclusion Criteria

• Non-English speaking participants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Elopement Questionnaire scores	Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)	The Elopement Questionnaire lists situations commonly reported as problematic by caregivers of children with ASD who elope. Aligned with the HSQ, caregivers indicate whether each situation is an issue, and if so, rate the severity from 1 (mild) to 9 (severe). The Elopement Questionnaire creates a total score by summing severity across items.
Feasibility Score Card	Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)	This score card includes measures of attendance (BCBAs will keep an attendance log to calculate completed sessions over the expected; score card success = 75% attendance), homework completion (BCBA will score completion ranging from 0 = no to 4 = all homework completed; Success is defined as \> 75% of sessions with a score ≥ 3), and therapist integrity (completion of a checklist at a subset of FBET appointments; success defined as \>80% accurate implementation) This data will be collected only for the FBET arm

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression - Improvement (CGI-I) Score	Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)	CGI-I asks an independent evaluator (IE) to rate the degree of improvement, compared to the last visit, on a scale of 1 (very much improved) through 4 (no change) to 7 (very much worse).
Change in Goal Attainment Scaling (GAS)	Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)	Goal Attainment Scaling (GAS) will measure appropriate behavior.; To assess appropriate behavior, at baseline, the independent evaluator (IE) will set 2 goals with the caregiver focused on appropriate behaviors that are relevant for the child's current developmental level. Goals will be weighted by the caregiver. The IE will rate goals at each subsequent assessment visit based on a discussion with the caregiver using a 5-point scale: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), and +2 (best expected outcome). Higher the score better the outcome.
Change in Elopement Safety Checklist Score	Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)	The Elopement Safety Checklist is a 22-item tool that helps families take steps to prevent elopement and improve safety if it does occur. Items include actions like installing locks or alarms, teaching traffic safety skills, and using identification bracelets. Parents mark "yes" or "no" for each item based on whether it has been completed. The total safety score is calculated as the percentage of items completed-higher scores reflect more safety measures in place to help prevent elopement or protect the child if they elope.

Trial Locations

Locations (1)

Marcus Autism Center; 🇺🇸 Atlanta, Georgia, United States