Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 主要终点
- Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
研究概览
简要总结
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. 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 the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the child has been diagnosed professionally with ASD
- •the child is currently receiving ABA therapy at least twice per week at home.
- •The child's family is willing to drive to Stanford University for up to 4 study appointments.
排除标准
- •The child scores less than 15 on the Social Communication Questionnaire
- •The child's family does not speak English
研究组 & 干预措施
Autism Glass Intervention
Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy.
干预措施: Autism Glass (Device)
Crossover Control for Autism Glass
Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18).
干预措施: Autism Glass (Device)
结局指标
主要结局
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
时间窗: Baseline (week 0), Week 6
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale will be conducted at the university by a trained research team member. Scores from the socialization domain of the VABS-II reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores (mean: 100 sd: 15) for each domain and for the composite adaptive behavior score.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.
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6
时间窗: Baseline (week 0), Week 6
The SRS-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 severity. Social 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 Emotion Guessing Game (EGG) Scores From Baseline to Week 6
时间窗: Baseline (week 0), Week 6
The Emotion Guessing Game is a novel test created for purposes of this study to evaluate the child's ability to correctly label emotions expressed by an examiner in real time. EGG is a pre-set list of 8 emotions, listed 5 times each (Happy, Sad, Angry, Afraid, Surprised, Calm, Disgust, and "Meh"/contempt). During the quick 40-question evaluation, the research coordinator first lists the various emotion choices to the child before beginning the evaluation. Then, the examiner acts out each emotion listed, in order, and waits for a guess from the child, who labels the emotion. The EGG is scored by summing the number of correct responses from the child, higher scores indicated better emotion recognition, where scores can range from 0 to 40.
次要结局
- Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6(Baseline (week 0), week 6)
- Change in Adaptive Social and Personal Skills as Measured by Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) Full Scale From Baseline to Week 6.(Baseline (week 0), week 6)
- Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score.(Baseline (week 0), Week 6)
- Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6(Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6)
研究者
Dennis Paul Wall
Associate Professor
Stanford University