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Investigation of Mechanisms of Action in Superpower Glass

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Superpower Glass
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring digital, autism, mobile health, ASD, mobile therapy, Google Glass, wearable computing, technology

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Facial Engagement

Emotion Recognition

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 6, 2019
Last Updated
August 30, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04049981
Brief Title
Investigation of Mechanisms of Action in Superpower Glass
Official Title
Examining Mechanisms of Action in Superpower Glass Behavioral Intervention for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
digital, autism, mobile health, ASD, mobile therapy, Google Glass, wearable computing, technology

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1:1 Randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facial Engagement
Arm Type
Experimental
Arm Description
This group will receive a version of Superpower Glass that targets specific areas of social deficits associated with autism.
Arm Title
Emotion Recognition
Arm Type
Experimental
Arm Description
This group will receive a version of Superpower Glass that targets different areas of social deficits associated with autism.
Intervention Type
Device
Intervention Name(s)
Superpower Glass
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in socialization subscale scores of the Vineland Adaptive Behavior Scales,3rd Edition (VABS-III) from baseline to week 4.
Description
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.
Time Frame
Baseline (Week 0), Week 4
Title
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 4
Description
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).
Time Frame
Baseline (Week 0), Week 4
Secondary Outcome Measure Information:
Title
Changes in Parent Self Agency Measure scores from Baseline to Week 4
Description
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.
Time Frame
Baseline (Week 0), Week 4
Title
Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4
Description
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.
Time Frame
Baseline (Week 0), Week 4
Other Pre-specified Outcome Measures:
Title
Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ) score at baseline
Description
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."
Time Frame
Baseline (Week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P Wall, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will become available after subject enrollment and data collection has completed.
Links:
URL
http://autismglass.stanford.edu/
Description
Study Recruitment and Information Website
URL
https://wall-lab.stanford.edu/
Description
Wall Lab Website

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Investigation of Mechanisms of Action in Superpower Glass

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