Investigation of Mechanisms of Action in Superpower Glass

Study Overview
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Brief Summary
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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.

Official Title
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Examining Mechanisms of Action in Superpower Glass Behavioral Intervention for Children With Autism

Conditions
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Autism Spectrum Disorder, Autism

Intervention / Treatment
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* Device: Superpower Glass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: Parent/Guardian unable to speak and read in English. Child with autism receives Social Communication Questionnaire score>15

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 Randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Facial Engagement<br>This group will receive a version of Superpower Glass that targets specific areas of social deficits associated with autism. | Device: Superpower Glass<br>* The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents.<br>|
| Experimental: Emotion Recognition<br>This group will receive a version of Superpower Glass that targets different areas of social deficits associated with autism. | Device: Superpower Glass<br>* The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in socialization subscale scores of the Vineland Adaptive Behavior Scales,3rd Edition (VABS-III) from baseline to 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. | Baseline (Week 0), Week 4 | 
| Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to 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). | Baseline (Week 0), Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Parent Self Agency Measure scores from Baseline to Week 4 | The Parent Self Agency Measure (PSAM) is a 5-item measure of parent's overall confidence in their ability to act in the parental role. Where higher scores indicate higher parent self-agency. | Baseline (Week 0), Week 4 | 
| Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4 | The Brief Observation of Social Communication Change (BOSCC) is designed to measure change in core symptoms of children with autism. It aims to capture change in social communication, interaction, and eye contact. The BOSCC is a semi-structured observation of interaction with parent and experimenter to assess social communication. The test contains 9 items to capture the quality of a child's social interaction, with total scores ranging from 0 to 45, and an additional 3 items to capture restricted repetitive behaviors, with total score of which ranges from 0 to 15. The BOSCC total score consists in the sum of the total score obtained in the first twelve items (ASD specific symptoms), and ranges from 0 to 60, with the three extra items added separately to integrate information. In the total and subscale scores, higher scores correspond to more severe symptoms. | Baseline (Week 0), Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, digital, autism, mobile health, mobile therapy, Google Glass, wearable computing, technology