Investigation of Mechanisms of Action in Superpower Glass

NCT04049981 | Terminated Phase 1

• 3 other identifiers: 34059PHIND Dream Team AwardSPARK Pilot Program
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

digital; autism; mobile health; ASD; mobile therapy; Google Glass; wearable computing; technology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in Parent Self Agency Measure scores from Baseline to Week 4

  Baseline (Week 0), Week 4

• Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4

  Baseline (Week 0), Week 4

Other Outcomes (1)

• Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ) score at baseline

  Baseline (Week 0)

Study Arms (2)

Facial Engagement

EXPERIMENTAL

This group will receive a version of Superpower Glass that targets specific areas of social deficits associated with autism.

Device: Superpower Glass

Emotion Recognition

EXPERIMENTAL

This group will receive a version of Superpower Glass that targets different areas of social deficits associated with autism.

Device: Superpower Glass

Interventions

Superpower Glass DEVICE

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.

Emotion Recognition; Facial Engagement

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Parent/Guardian unable to speak and read in English.
• Child with autism receives Social Communication Questionnaire score\>15

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Links

• Study Recruitment and Information Website
• Wall Lab Website

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dennis P Wall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 1:1 Randomization

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 4, 2019
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after subject enrollment and data collection has completed.

Locations

US (1)