Clinical trial NCT03899831: Structured Function-Based Elopement Treatment Program
Official title: A Randomized Clinical Trial of a Structured Function-Based Elopement Treatment Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Elopement
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2019-04-02
Enrollment: 76
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change in Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Week 16
measure: Change in Home Elopement Safety Checklist (HESC) Score
timeFrame: Baseline, Week 16
measure: Direct observation of elopement frequency
timeFrame: Baseline, Week 16
measure: Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score
timeFrame: Week 16, Week 28
measure: Change in Clinical Global Impression - Improvement (CGI-I) Score
timeFrame: Week 28
measure: Change in Home Elopement Safety Checklist (HESC) Score
timeFrame: Week 16, Week 28
Other outcomes:
measure: Change in Aberrant Behavior Checklist - Irritability (ABC-I) Scale Score
timeFrame: Baseline, Week 16
Locations:
city: Atlanta
country: United States
facility: Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Mindy Scheithauer, PhD
role: PRINCIPAL_INVESTIGATOR
References: