Structured Function-Based Elopement Treatment Program
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      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).
    

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
    

Intervention name(s): Function-Based Elopement Treatment (FBET); Parent Education Program (PEP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to FBET or PEP in a 1:1 ratio using random permuted blocks of size 2 and 4. After Wk 16, participants in the PEP group will be offered the FBET.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elopement