Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

Overview

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.

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 reinforce
• 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 inf

Primary outcome measures

• Change in Elopement Questionnaire scores [Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)]
• Feasibility Score Card [Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)]

Secondary outcome measures (3)

• Change in Clinical Global Impression - Improvement (CGI-I) Score [Time frame: Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)]
• Change in Goal Attainment Scaling (GAS) [Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)]
• Change in Elopement Safety Checklist Score [Time frame: Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

• Marcus Autism Center — Atlanta

Identifiers

NCT: NCT07194083 · STUDY00009456 · 1R34MH136125-01A1 · 2025P010607

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗