Effectiveness- Implementation Trial of the Function-Based Elopement Treatment

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07194083
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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

Key Dates

Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: FBET: Function-Based Elopement Treatment
    Clinicals randomized to FBET intervention
  • Active Comparator: TAU: Treatment as Usual
    Clinics randomized to the TAU intervention.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Marcus Autism CenterAtlantaGeorgia30329
Mindy Scheithauer, PhD
[email protected]
404-785-9322

Find similar trials in Atlanta, GA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Marcus Autism Center· Atlanta, GA

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