Effectiveness- Implementation Trial of the Function-Based Elopement Treatment
ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorEmory University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Function-Based Elopement Treatment
BehavioralFBET 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
BehavioralTAU 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: FBET: Function-Based Elopement TreatmentExperimental treatment 1 intervention
Group B: TAU: Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)2
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
Time frame
Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)Secondary outcomes
1
Change in Clinical Global Impression - Improvement (CGI-I) Score
CGI-I asks an independent evaluator (IE) to rate the degree of improvement, compared to the last visit, on a scale of 1 (very much improved) through 4 (no change) to 7 (very much worse).
Time frame
Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)2
Change in Goal Attainment Scaling (GAS)
Goal Attainment Scaling (GAS) will measure appropriate behavior. To assess appropriate behavior, at baseline, the independent evaluator (IE) will set 2 goals with the caregiver focused on appropriate behaviors that are relevant for the child's current developmental level. Goals will be weighted by the caregiver. The IE will rate goals at each subsequent assessment visit based on a discussion with the caregiver using a 5-point scale: -2 (worse expected outcome), -1 (less than expected outcome), 0 (expected outcome), +1 (more than expected outcome), and +2 (best expected outcome). Higher the score better the outcome.
Time frame
Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)3
Change in Elopement Safety Checklist Score
The Elopement Safety Checklist is a 22-item tool that helps families take steps to prevent elopement and improve safety if it does occur. Items include actions like installing locks or alarms, teaching traffic safety skills, and using identification bracelets. Parents mark "yes" or "no" for each item based on whether it has been completed. The total safety score is calculated as the percentage of items completed-higher scores reflect more safety measures in place to help prevent elopement or protect the child if they elope.
Time frame
Baseline, Mid point (8-10 weeks), End point (20 weeks), follow up (32 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov