跳至主要内容
临床试验/NCT03814902
NCT03814902已完成不适用

A Prospective Pilot Study to Characterize the Impact on Families of Electronic Tracking Device Use by Children With Autism Spectrum Disorders Who Wander

Northwell Health1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年1月15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
31
试验地点
1
主要终点
Rates of participant retention

研究概览

简要总结

This pilot study will obtain preliminary data about the impact of wearable electronic tracking devices (ETDs) as an intervention for children with autism spectrum disorders (ASD) who wander. The feasibility of all study procedures and the acceptability of the intervention will be evaluated.

详细描述

Wandering, or elopement, is a life-threatening behavior that has been reported to occur in a third of all children with autism spectrum disorders (ASD). Wearable electronic tracking devices (ETDs) that are able to pinpoint a child's location have emerged as an appealing intervention for families concerned about wandering risk. However, the impact of ETD use on the families of children who wander has never been studied prospectively. In this pilot study, parents will be provided with a commercially-available ETD to use for their child with ASD for 6 weeks. Preliminary data will be obtained to evaluate the impact of ETD use on the strain experienced by families due to their child's wandering behavior. The feasibility of all study procedures will be assessed in preparation for a larger subsequent trial.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least 18 years of age
  • •Parent of a child between the ages of 4 and 17 who currently has autism spectrum disorder (ASD), was diagnosed with ASD by a professional, and has wandered at least once in the preceding 3 months
  • •Currently lives in the United States
  • •Currently lives with child with ASD
  • •Has been living with child with ASD for at least 6 months
  • •Has reliable internet access to allow for completion of online questionnaires

排除标准

  • •Current or past use of any electronic tracking device to address wandering behavior in the child with ASD

研究组 & 干预措施

Electronic Tracking Device

Experimental

Participants will be given a wearable electronic tracking device (ETD) to use for their child with autism spectrum disorder (ASD) for 6 weeks.

干预措施: Electronic Tracking Device (Device)

结局指标

主要结局

Rates of participant retention

时间窗: 6 weeks

Participant retention will be assessed to evaluate the feasibility of all study procedures.

Rates of questionnaire completion

时间窗: 6 weeks

Questionnaire completion rates will be calculated to assess the feasibility of the proposed evaluation schedule.

Adherence to the intervention

时间窗: 6 weeks

The mean daily duration of participant use of the device will be assessed to evaluate the acceptability of the intervention.

次要结局

  • Changes from baseline in Caregiver Strain Questionnaire (CGSQ) scores(Baseline and Week 6)
  • Changes from baseline in GAD-7 scores(Baseline, Week 6)
  • Changes from baseline in BFDS scores(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
  • Changes from baseline in the frequency of wandering-related disruptions to the household.(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6)
  • Perceived impact of the intervention(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验