跳至主要内容
临床试验/NCT04909710
NCT04909710Enrolling By Invitation不适用

Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Stanford University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
2
主要终点
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver

研究概览

简要总结

The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).

研究设计

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

入排标准

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

入选标准

  • Parent or primary caregiver over 18 of a child with autism between ages of 2 and
  • Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

排除标准

  • Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.

结局指标

主要结局

Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver

时间窗: Baseline (Week 0), Week 12

The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (IQ) type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.

Mobile Application Usage-Total games started.

时间窗: Week 12

App usage data by participants (children) comprised of total number of MojiMatch plus Charades Games started.

次要结局

  • Change in parent reported social responsiveness from week 0 to week 12(Baseline (Week 0), Week 12)
  • Change in mobile autism risk assessment score from week 0 to week 12(Baseline (Week 0), Week 12)

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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