Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 300
- 试验地点
- 1
- 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
- 是
入选标准
- •Parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old.
- •Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.
排除标准
- •(1) Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
研究组 & 干预措施
Autism Case Group
Autistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
干预措施: Mobile Game System for Potential Treatment of Developmental Delays (Other)
Neurotypical Sibling Control Group
Neurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
干预措施: Mobile Game System for Potential Treatment of Developmental Delays (Other)
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
Dennis Paul Wall
Associate Professor
Stanford University