Effectiveness- Implementation Trial of the Function-Based Elopement Treatment ((FBET))

Emory University

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Treatment as Usual; Behavioral: Function-Based Elopement Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07194083

STUDY00009456

1R34MH136125-01A1 (U.S. NIH Grant/Contract)

2025P010607 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

FBET: Function-Based Elopement Treatment

Experimental group

Description:

Clinicals randomized to FBET intervention

Treatment:

Behavioral: Function-Based Elopement Treatment

TAU: Treatment as Usual

Active Comparator group

Description:

Clinics randomized to the TAU intervention.

Treatment:

Behavioral: Treatment as Usual