Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

NCT07194083 | Not Yet Recruiting DMC

• 3 other identifiers: STUDY000094561R34MH136125-01A12025P010607
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Autism Spectrum Disorder

Keywords

Function Based Elopement Treatment; Autism Spectrum Disorder; Applied Behavior Analysis; Elopement; Functional Analysis

Outcome Measures

Primary Outcomes (2)

• Change in Elopement Questionnaire scores

  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.

  Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)

• Feasibility Score Card

  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

  Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)

Secondary Outcomes (3)

• Change in Clinical Global Impression - Improvement (CGI-I) Score

  Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)

• Change in Goal Attainment Scaling (GAS)

  Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)

• Change in Elopement Safety Checklist Score

  Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)

Study Arms (2)

FBET: Function-Based Elopement Treatment

EXPERIMENTAL

Clinicals randomized to FBET intervention

Behavioral: Function-Based Elopement Treatment

TAU: Treatment as Usual

ACTIVE COMPARATOR

Clinics randomized to the TAU intervention.

Behavioral: Treatment as Usual

Interventions

Function-Based Elopement Treatment 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.

Also known as: FBET

FBET: Function-Based Elopement Treatment

Treatment as Usual 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

Also known as: TAU

TAU: Treatment as Usual

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Non-English speaking participants

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Emory University: lead

Study Sites (1)

Marcus Autism Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mindy Scheithauer

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindy Scheithauer, PhD

CONTACT

404-785-9322; Mindy.Scheithauer@choa.org

Auscia Williams

CONTACT

Auscia.Williams@choa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: September 26, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be entered following standard NDA guidelines, with submissions completed by January 15th and July 15th each year during the study period.
• Access Criteria: All of the data is on NDA

Locations

US (1)