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临床试验/NCT02383732
NCT02383732已完成不适用

A Feasibility Study of the Elopement Prevention and Safety Training Program

Emory University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)

研究概览

简要总结

The purpose of this study is to demonstrate the feasibility of the Elopement Prevention Safety (EPST) program in children with autism spectrum disorder (ASD) who have engaged in eloping. This is a program created by the Behavior Treatment Clinics to help caregivers come up with a safety plan to prevent their children from running away or wandering off.

详细描述

A large number of children with autism spectrum disorder (ASD) have a current or past history of elopement. For parents of a child with ASD, having their child go missing is potentially dangerous and far more likely compared to typically developing children. This behavior interferes with household routines, engenders vigilance, and restricts the family's participation in their community. Such restrictions contribute to the family's isolation and hinders development of community supports. Elopement can result in injuries and deaths of children with ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Males and females, ages 4 to 12 inclusive
  • Diagnosis of ASD as determined by clinical interview and supported by standardized measures (i.e., Autism Diagnostic Observation Schedule-2, Vineland, Stanford-Binet V)
  • Engages in elopement in the form of bolting or wandering, as determined by structured interview
  • A caregiver who expresses a willingness to participate in treatment and complete baseline/outcome assessments.

排除标准

  • Unmanaged psychopathology or problem behavior other than elopement that warrants immediate clinical care, determined by clinical interview and Aberrant Behavior Checklist (ABC)
  • Child and family currently in therapy that is likely to be redundant with the treatment program or interfere with proposed treatment
  • Presence of both of the types of elopement under investigation (i.e., both bolting and wandering).

结局指标

主要结局

Feasibility of intervention, assessed by change in severity on Clinical Global Impression for Severity (CGI-S)

时间窗: Post-intervention (12-14 weeks)

An independent evaluator (IE) will conduct a parent target problem survey to help caregivers estimate the frequency of elopement as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's elopement. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients

次要结局

  • Change in elopement behavior(Post-intervention (12-14 weeks))

研究者

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

Nathan A. Call, Ph.D., BCBA-D

Instructor

Emory University

研究点 (2)

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