Examining Mechanisms of Action in Superpower Glass Behavioral Intervention for Children With Autism
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 4
研究概览
简要总结
The following study aims to understand the mechanism of action at work in a novel artificial intelligence (AI) tool that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This study will examine 2 versions of software on the Google Glass based wearable intervention system. Participants will receive 1 of 2 versions of the software and use the device at home for 4 weeks. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that both mechanisms under investigation will contribute to social gains in children over the 4 week period of use.
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent of a child with a professional diagnosis of autism who is at least 18 years old.
- •Child with autism is 4-8 years old
- •Parent/Guardian is able to drive to Stanford University for 2 in lab appointments.(Lives within driving distance of Stanford University).
排除标准
- •Parent/Guardian unable to speak and read in English.
- •Child with autism receives Social Communication Questionnaire score>15
结局指标
主要结局
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 4
时间窗: Baseline (Week 0), Week 4
The Social Responsiveness Scale-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Change in socialization subscale scores of the Vineland Adaptive Behavior Scales,3rd Edition (VABS-III) from baseline to week 4.
时间窗: Baseline (Week 0), Week 4
Vineland Adaptive Behavior Scales, 3rd edition (VABS-III) 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 32 items, where raw scores are converted to 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.
次要结局
- Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4(Baseline (Week 0), Week 4)
- Changes in Parent Self Agency Measure scores from Baseline to Week 4(Baseline (Week 0), Week 4)
研究者
Dennis Paul Wall
Associate Professor
Stanford University