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临床试验/NCT04739982
NCT04739982已完成不适用

A Lead-in Study Evaluating Mobile Game Based Therapy Among Children With Autism

Stanford University2 个研究点 分布在 1 个国家目标入组 555 人开始时间: 2021年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
555
试验地点
2
主要终点
Change in Parent Reported Socialization Based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, From Baseline to Week 4

研究概览

简要总结

The following study aims to assess the efficacy, safety data, and best outcome measurements of the mobile game platform, GuessWhat, in delivering behavioral therapy to children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

详细描述

The following study aims to understand the efficacy and safety of the mobile game platform, GuessWhat, in delivering behavioral therapy to children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 4 weeks.

研究设计

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

入排标准

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

入选标准

  • Parent who is at least 18 years old of child with autism.
  • Child with autism is between 3 and 12 years old at time of baseline data collection.

排除标准

  • Parent is unable to read English.
  • Parent does not have an Android or iOS smartphone compatible with GuessWhat App--the app will be available on Android after further development and we will notify interested families when it becomes available.

结局指标

主要结局

Change in Parent Reported Socialization Based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, From Baseline to Week 4

时间窗: Baseline (Week 0), Week 4

Vineland Adaptive Behavior Scales, 3rd edition (VABS-3) Socialization subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the socialization domain of the VABS-III reflects one's functioning in social situations. The socialization subscale is up to 112 items depending on age and development, where raw scores are converted to IQ-type standard scores with mean 100 and standard deviation of 15, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. The range for each subscale is 20 to 140.

次要结局

  • Change in Parental Stress Scale - From Baseline to Week 4(Baseline (Week 0), Week 4)
  • GuessWhat App Usage Data(Baseline through week 4 (assessed at week 4))
  • Change in Emotion Recognition From Baseline to Week 4(Baseline (Week 0), Week 4)

研究者

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

Dennis Paul Wall

Associate Professor

Stanford University

研究点 (2)

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