Investigation of Mechanisms of Action in Superpower Glass

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

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Device: Superpower Glass

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facial Engagement; This group will receive a version of Superpower Glass that targets specific areas of social deficits associated with autism.	Device: Superpower Glass; 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.
Experimental: Emotion Recognition; This group will receive a version of Superpower Glass that targets different areas of social deficits associated with autism.	Device: Superpower Glass; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ) score at baseline	The ABIQ assessment measures a child's IQ based on an abbreviated (10 minute) task that measures Nonverbal Fluid Reasoning and Verbal Knowledge to create a standard score for IQ. It will be completed for each child during Intake. The Area Scores and Test Composite on the Stanford-Binet test have an average score of 100 and a standard deviation of 16. The converted score of the individual being assessed indicates where he/she is relative to the norm. A score exceeding 145 is classified as "Genius or near genius," and scores below 70 are classified as "Borderline deficiency."	Baseline (Week 0)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Dennis P Wall, PhD, Stanford University

Publications and helpful links

Helpful Links

• Study Recruitment and Information Website
• Wall Lab Website

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: mobile health; autism; ASD; technology; Google Glass; digital; mobile therapy; wearable computing
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 34059; PHIND Dream Team Award (Other Identifier: Stanford University); SPARK Pilot Program (Other Identifier: Stanford University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will become available after subject enrollment and data collection has completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No