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临床试验/NCT01655485
NCT01655485已完成不适用

Effect of a Social Script iPAD Application for Children With Autism Spectrum Disorder(ASD) Undergoing Medical Imaging Procedures

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年10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
32
试验地点
2
主要终点
Child behaviors

研究概览

简要总结

The purpose of the research is to test the effectiveness of the social story intervention delivered using the iPAD application "Going to Imaging" on the anxiety, challenging child behaviors, child injuries and completion rates among children with ASD undergoing medical imaging procedures. A secondary purpose is to test the effect of this intervention on the anxiety levels of the parents of ASD children undergoing medical imaging procedures.

Hypotheses:

H1: Children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging compared with children with ASD exposed to treatment as usual (TAU) will have:

  1. Lower anxiety as measured by heart rate respiratory rate, and blood pressure (baseline compared to up to two hours later).
  2. Exhibit fewer challenging behaviors as measured by a behavior observation scale (developed for the study (up to 2 hours after baseline)
  3. Higher procedure completion rate.
  4. Shorter time to complete a procedure.
  5. Less child injuries.

H2: Compared to parents of ASD children exposed to treatment as usual (TAU), parents of children with ASD who are exposed to a story book "Here the investigators go to medical imaging (x-ray)" to prepare for medical imaging will have: 6. Lower state anxiety as measured by the State Anxiety Inventory ( baseline ).

详细描述

Parent state anxiety is measured at baseline with the 20-item State anxiety measure from www.mindgarden.com. Child anxiety is measured at baseline with vital signs (heart rate, blood pressure, respiratory rate). Behaviors will be observed and recorded on the behavior observation tool up to 2 hours after the baseline measure (during the imaging).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with autism spectrum disorder
  • English speaking parent or guardian.

排除标准

  • Non-english speaking parent or guardian
  • Severe autism as defined by caregiver or health care provider.

结局指标

主要结局

Child behaviors

时间窗: up to 2 hours

Child behaviors measured during imaging procedures with the behaviors observation tool created for this study.

次要结局

  • Parent anxiety(Baseline)

研究者

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

Norah L. Johnson

Assistant Profesor Marquette University

Medical College of Wisconsin

研究点 (2)

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