Evaluating Efficacy of a Digital Game Based Therapeutic for Improving Socialization Outcomes in Autistic Children, A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 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 8
研究概览
简要总结
The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in 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 of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. 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 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The parent will know whether their child is receiving the treatment or not as they administer the treatment.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.
排除标准
- •Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
- •Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
- •Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.
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 8
时间窗: Baseline (Week 0), Week 8
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 Intellectual Quotient-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.
次要结局
- Change in Parental Stress Scale - from baseline to week 8(Baseline (Week 0), Week 8)
- Change in Emotion Recognition from baseline to week 8(Baseline (Week 0), Week 8)
研究者
Dennis Paul Wall
Professor
Stanford University