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临床试验/NCT03899831
NCT03899831已完成不适用

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

Emory University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome measures will be administered by a blinded independent evaluator.

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Function-Based Elopement Treatment (FBET)

Experimental

Participants in this group will receive Function-Based Elopement Treatment (FBET) for 16 weeks.

干预措施: Function-Based Elopement Treatment (FBET) (Behavioral)

Parent Education Program (PEP)

Active Comparator

Participants in this group will take part in a parent education program (PEP) for 16 weeks.

干预措施: Parent Education Program (PEP) (Behavioral)

结局指标

主要结局

Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score

时间窗: Baseline, Week 16

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.

次要结局

  • Direct observation of elopement frequency(Baseline, Week 16)
  • Change in Clinical Global Impression - Improvement (CGI-I) Score(Week 28)
  • Change in Aberrant Behavior Checklist - Hyperactivity (ABC-H) Subscale Score(Week 16, Week 28)
  • Change in Home Elopement Safety Checklist (HESC) Score(Week 16, Week 28)
  • Change in Clinical Global Impression - Improvement (CGI-I) Score(Week 16)
  • Change in Home Elopement Safety Checklist (HESC) Score(Baseline, Week 16)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mindy Scheithauer

Associate Professor

Emory University

研究点 (1)

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