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Investigation of Mechanisms of Action in Superpower Glass

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ClinicalTrials.gov Identifier: NCT04049981
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Paul Wall, Stanford University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Device: Superpower Glass Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 Randomization
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining Mechanisms of Action in Superpower Glass Behavioral Intervention for Children With Autism
Actual Study Start Date : September 4, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. Change in socialization subscale scores of the Vineland Adaptive Behavior Scales,3rd Edition (VABS-III) from baseline to week 4. [ Time Frame: Baseline (Week 0), 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.

  2. Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 4 [ Time Frame: Baseline (Week 0), 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 :
  1. Changes in Parent Self Agency Measure scores from Baseline to Week 4 [ Time Frame: Baseline (Week 0), 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.

  2. Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 4 [ Time Frame: Baseline (Week 0), 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.


Other Outcome Measures:
  1. Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ) score at baseline [ Time Frame: Baseline (Week 0) ]
    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."



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049981


Contacts
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Contact: Kaiti Dunlap 650-497-9214 kaiti.dunlap@stanford.edu
Contact: Jessey Schwartz 650-497-9214 jesseys@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Kaiti Dunlap, MRes    650-497-9214    kaiti.dunlap@stanford.edu   
Principal Investigator: Dennis P Wall, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Dennis P Wall, PhD Stanford University

Additional Information:
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Responsible Party: Dennis Paul Wall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04049981     History of Changes
Other Study ID Numbers: 34059
PHIND Dream Team Award ( Other Identifier: Stanford University )
SPARK Pilot Program ( Other Identifier: Stanford University )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: Data will become available after subject enrollment and data collection has completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dennis Paul Wall, Stanford University:
digital
autism
mobile health
ASD
mobile therapy
Google Glass
wearable computing
technology
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors