Recruiting

FBET

Sponsor:

Emory University

Code:

NCT07194083

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

Function-Based Elopement Treatment

Treatment as Usual

Study Details

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

Study ID

NCT07194083

Start date

Mar 30, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: FBET: Function-Based Elopement Treatment

Clinicals randomized to FBET intervention

active comparator: TAU: Treatment as Usual

Clinics randomized to the TAU intervention.

Interventions

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.

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Mindy Scheithauer, PhD

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

Auscia Williams

Auscia.Williams@choa.org

Locations

Marcus Autism Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Mindy Scheithauer, PhD

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

More Information

Sponsor

Emory University

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Emory University on 2026-06-18.