Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2028-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster Randomization: Random assignment to the treatments, FBET or TAU, will be at the clinic-level, and all participants will receive the intervention to which their respective clinic is assigned.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Random assignment to the treatments, FBET or TAU, will occur at the clinic level, and all participants will receive the intervention to which their respective clinic is assigned. Randomizations will be blinded to investigators responsible for assessing outcomes (independent evaluators) throughout the study and arranged in a 1:1 ratio (N=3 clinics per intervention, N=6 total) with stratification, ensuring approximately equal representation of clinic sizes (small versus large) between randomized study interventions

Study Groups

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FBET: Function-Based Elopement Treatment

Clinicals randomized to FBET intervention

Group Type EXPERIMENTAL

Function-Based Elopement Treatment

Intervention Type BEHAVIORAL

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.

TAU: Treatment as Usual

Clinics randomized to the TAU intervention.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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FBET TAU

Eligibility Criteria

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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.