Structured Function-Based Elopement Treatment Program (FBET)

A Randomized Clinical Trial of a Structured Function-Based Elopement Treatment Program

This study aims to extend the researchers' prior work on Function-Based Elopement Treatment (FBET) with a randomized controlled trial to evaluate the efficacy of FBET in 76 children with autism spectrum disorder (ASD) and elopement. Participants will be randomized to FBET or an active control group receiving a parent education program (PEP). Each study arm will include 12 appointments over 16 weeks and will be administered by a Board Certified Behavior Analyst (BCBA).

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Function-Based Elopement Treatment (FBET); Behavioral: Parent Education Program (PEP)

Detailed Description

Elopement (running/wandering away from supervision) affects nearly 50% of children with ASD and is a contributor to the fact that children with ASD have nearly double the premature death rate of their typically developing peers. Existing interventions, such as prevention kits, increase safety by decreasing elopement opportunities (e.g., locking doors), but do not necessarily decrease attempts. Given that a single successful attempt can be fatal, the fact that prevention-only strategies cannot eliminate elopement means that other treatment approaches are necessary. Interventions based in applied behavior analysis (ABA) have been successful in reducing elopement attempts. ABA relies on function-based treatments, which start with assessment to identify why an individual elopes (i.e., its function). Common functions of elopement include accessing attention (e.g., parent's reaction), preferred items (e.g., toys), or escape from nonpreferred situations (e.g., leaving a store). Function is crucial, as common strategies may be contraindicated based on function. For example, a caregiver may pick up a child and discuss safety after elopement. Unfortunately, this may reinforce elopement, and make it worse, if the function for that child is to gain attention. Key elements of function-based treatments include preventing delivery of the functional reinforcer following elopement (i.e., extinction) and teaching an appropriate means of accessing it instead.

While there is support in the literature for function-based treatments, it has relied on small sample sizes. In the largest elopement treatment study to date, the researchers demonstrated significant improvements based on clinical outcomes. However, even this study was relatively small (N=11) and lacked a control group. The bulk of research supporting these interventions has also been conducted in specialized treatment centers by doctoral level professionals. This is in contrast to the majority of ABA services delivered by Master level Board Certified Behavior Analysts (BCBAs) operating in community settings. Thus, even if ABA-based interventions are efficacious, their generality and community viability remain unknown. Finally, research has evaluated either prevention strategies or function-based interventions, while studies combining these are strikingly absent.

A randomized controlled trial designed to test the efficacy of a structured, exportable intervention for elopement with prevention strategies and function-based interventions has not been conducted, but is critical for several reasons. First, rigorous studies with a control group and sufficient sample size are needed for function-based treatments to be widely accepted as empirically supported. Second, evaluation of a manualized intervention combining these approaches implemented in a community context will demonstrate the viability outside of specialized clinics. A manualized treatment can serve as a much needed resource for community providers faced with treating elopement. The researchers have developed a manualized, parent-mediated intervention called Function-Based Elopement Treatment (FBET). In a pilot feasibility study the researchers evaluated FBET with 24 children with ASD (age 4 to 12), who were randomly assigned to FBET (n=12) or a waitlist (n=12).

In this study, participants will be randomized to receive the FBET intervention or PEP for 16 weeks. Participants in the PEP study arm will be offered the opportunity to have the FBET intervention at the end of the 16 week study period. The study aims are to:

Aim 1: Evaluate whether FBET is superior to PEP in reducing elopement in 76 children (age ≥ 4 to ≤ 12) with ASD after 16 weeks of treatment using the Aberrant Behavior Checklist-Hyperactivity subscale (ABC-H).

Aim 2: Evaluate two key secondary outcomes (at Wk 16): a) the independent evaluator ratings on the Clinical Global Impression-Improvement rating (CGI-I) and b) home safety, based on the percentage of prevention items endorsed on the home elopement safety checklist (HESC).

Aim 3: Evaluate whether direct observation of elopement, based on parent data on elopement frequency for one week leading up to each assessment point, demonstrates a significant decrease in the FBET compared to PEP participants.

Aim 4: Evaluate whether gains made in the FBET group are maintained after treatment (at Wk 28, using the ABC-H, HESC, and CGI-I)

Exploratory Aim 1: To evaluate the impact of FBET on disruptive behavior using the ABC-Irritability subscale

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Marcus Autism Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥ 4 to ≤ 12
• diagnosis of ASD, confirmed by clinical characterization of an Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview-Revised (ADI-R), or Childhood Autism Rating Scale-Second Edition (CARS-2), cognitive (e.g., Differential Abilities Scale [DAS], Mullen Scales of Early Learning [MSEL or Mullen]), and adaptive assessments (Vineland Adaptive Behavior Scales-Third Edition [Vineland-3])
• chief complaint of elopement
• an ABC-H score > 18

Exclusion Criteria:

• caregivers who report they cannot reliably attend appointments
• ongoing or planned treatment that would likely impact elopement
• challenging behavior that should be treated prior to elopement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Function-Based Elopement Treatment (FBET); Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks.	Behavioral: Function-Based Elopement Treatment (FBET); The Function-Based Elopement Treatment (FBET) includes 12 appointments over 16 weeks. FBET focuses on parent-training, with the parent implementing procedures with therapist support. The goals of FBET are: to create a safer environment; teach adaptive skills to replace elopement; arrange the environment and rewards to reduce elopement; and teach caregivers how to respond if elopement occurs Psychoeducation is emphasized, including discussions of elopement as a learned behavior, reinforcement, functions of elopement, extinction, and descriptions of treatment components. The FBET manual includes scripted text, examples, caregiver completed activities, and checks for understanding.
Active Comparator: Parent Education Program (PEP); Participants in this group will take part in a parent education program (PEP) for 16 weeks.	Behavioral: Parent Education Program (PEP); The Parent Education Program (PEP) will include 12 appointments over 16 weeks, focused on general education about autism spectrum disorder and resources about elopement prevention. PEP will be administered by a Board Certified Behavior Analyst (BCBA). Participants randomized to the PEP study arm can receive the FBET intervention after completing the 16 week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score	Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impression - Improvement (CGI-I) Score	CGI-I asks an independent evaluator 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).	Week 16
Change in Home Elopement Safety Checklist (HESC) Score	The Home Elopement Safety Checklist (HESC) is a 22-item instrument listing steps to prevent elopement (e.g., locks, alarms) and decrease safety risk if elopement were to occur (e.g., purchasing identification bracelets). Parents indicate if each item has been completed or not and the percentage of completed items is the total safety score. The a higher percentage means that more safety elements have been implemented in order to reduce elopement or to increase the child's safety if they do elope.	Baseline, Week 16
Direct observation of elopement frequency	The frequency of elopement will be assessed based on parent data on elopement frequency for one week leading up to each assessment point.	Baseline, Week 16
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score	To evaluate whether gains made in the FBET group are maintained after treatment, the ABC-H will be repeated at the Week 28 follow up visit. Elopement will be measured by the hyperactivity subscale of the Aberrant Behavior Checklist (ABC-H). The full ABC is a 58-item caregiver completed measure with 5 subscales. It is used extensively with children with ASD in clinical trials and has demonstrated validity and reliability with this population. Although the ABC-H targets hyperactivity, there are several items directly related to elopement. The hyperactivity subscale includes 16 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 48, where higher scores indicate a higher severity of hyperactivity.	Week 16, Week 28
Change in Clinical Global Impression - Improvement (CGI-I) Score	To evaluate whether gains made in the FBET group are maintained after treatment, the CGI-I will be repeated at the Week 28 follow up visit. CGI-I asks an independent evaluator 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).	Week 28
Change in Home Elopement Safety Checklist (HESC) Score	To evaluate whether gains made in the FBET group are maintained after treatment, the HESC will be repeated at the Week 28 follow up visit. The HESC is a 22-item instrument listing steps to prevent elopement (e.g., locks, alarms) and decrease safety risk if elopement were to occur (e.g., purchasing identification bracelets). Parents indicate if each item has been completed or not and the percentage of completed items is the total safety score. The a higher percentage means that more safety elements have been implemented in order to reduce elopement or to increase the child's safety if they do elope.	Week 16, Week 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aberrant Behavior Checklist - Irritability (ABC-I) Scale Score	This exploratory aim evaluates the impact of FBET on disruptive behavior, as measured by the irritability subscale of the Aberrant Behavior Checklist (ABC-I). The full ABC is a 58-item caregiver completed measure with 5 subscales. The irritability subscale includes 15 items that are answered on a scale of 0 (not a problem) to 3 (severe problem). Scores for this subscale range from 0 to 45, where higher scores indicate increased severity of disruptive behavior.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Autism Speaks
• Investigators: Principal Investigator: Mindy Scheithauer, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): April 3, 2023
• Study Completion (Actual): May 4, 2023

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Elopement
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: IRB00108995

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) collected during the trial, will be available for sharing following deidentification.
• IPD Sharing Time Frame: IPD will be shared beginning 3 months after article publication and ending 5 years following publication.
• IPD Sharing Access Criteria: IPD will be shared with researchers providing a methodologically sound proposal in order to achieve the aims in the proposal or for meta-analyses. Proposals should be directed to Mindy.Scheithauer@choa.org. To gain access, data requestors may need to sign a data access agreement. Proposals may be submitted up to 5 years following article publications.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No