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Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03569176
Recruitment Status : Completed
First Posted : June 26, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dennis Paul Wall, Stanford University

Brief Summary:
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. 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 the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Autism Glass Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : April 11, 2018
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autism Glass Intervention
Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy.
Device: Autism 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 or during ABA therapy.

Crossover Control for Autism Glass
Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18).
Device: Autism 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 or during ABA therapy.




Primary Outcome Measures :
  1. Change in socialization subscale scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) from baseline to week 6. [ Time Frame: Baseline (week 0), Week 6 ]
    Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale will be conducted at the university by a trained research team member. Scores from the socialization domain of the VABS-II reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores (mean: 100 sd: 15) for each domain and for the composite adaptive behavior score.

  2. Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 6 [ Time Frame: Baseline (week 0), Week 6 ]
    The SRS-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 severity.

  3. Change in NEPSY-II, Affect Recognition subscale scores from baseline to week 6 [ Time Frame: Baseline (week 0), Week 6 ]
    The NEPSY-II Affect Recognition subdomain assesses a child's social perception of facial affect recognition. It is designed to assess a child's ability to recognize 6 emotions (happy, sad, angry, fear, disgust, and neutral) from colored photographs of children's faces in four different tasks.

  4. Change in Emotion Guessing Game (EGG) scores from baseline to week 6 [ Time Frame: Baseline (week 0), Week 6 ]
    The Emotion Guessing Game is a novel test created for purposes of this study to evaluate the child's ability to correctly label emotions expressed by an examiner in real time. EGG is a pre-set list of 8 emotions, listed 5 times each (Happy, Sad, Angry, Afraid, Surprised, Calm, Disgust, and "Meh"/contempt). During the quick 40-question evaluation, the research coordinator first lists the various emotion choices to the child before beginning the evaluation. Then, the examiner acts out each emotion listed, in order, and waits for a guess from the child, who labels the emotion. The EGG is scored by summing the number of correct responses from the child.


Secondary Outcome Measures :
  1. Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 6 [ Time Frame: Baseline (week 0), week 6 ]
    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 play based assessment that consists of two boxes filled with specific toys and takes about 12 minutes to complete.

  2. Change in adaptive social and personal skills as measured by Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Full Scale from baseline to week 6. [ Time Frame: Baseline (week 0), week 6 ]
    The VABS-II is a robust and comprehensive measure of personal and social skills needed in everyday living. The VABS-II covers a child's conceptual, social, and practical skills and can assess children from birth to 90 years. The parent can complete the entire questionnaire in about 20-30 minutes.

  3. Change in child's emotional, behavioral, and social problems from Baseline (week 0) to Week 6 as measured by Child Behavior Checklist (CBCL). [ Time Frame: Baseline (week 0), Week 6 ]
    The CBCL is a caregiver-directed report that identifies emotional, behavioral, and social problems in children. It is a 20 item measure completed by parents.


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.

  2. Mobilized Machine Learning Autism Risk Assessment (MARA) score of autism severity at baseline [ Time Frame: Baseline (week 0) ]
    The MARA screens for, quantifies, and tracks the severity of core autism symptoms. Parents respond to the survey and it takes less than 5 minutes to complete. The core behavioral domains the MARA focuses on are communication, social reciprocity, and restricted, repetitive, and stereotyped behaviors. Each response to a question is run through a machine learning model that uses an alternating decision tree algorithm to generate a total score ranging from most severe, -10 to least severe, 7.

  3. Social Communication Questionnaire (SCQ) score at baseline [ Time Frame: Baseline (week 0) ]
    The social communication questionnaire (SCQ) screens for autism in children over 4:0 years in age. Parents are asked 40 Yes/No questions and the resulting score is out of 39 (the first question is not associated with a numerical value). The SCQ assesses a child's communication skills and social functioning. It takes less than 10 minutes to complete and is administered by clinical research coordinators to parents of children during the phone screen to participants who have already completed the online screening questionnaire. A score of 15 or above is indicative of autism and is required to be eligible in the research study.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. the child has been diagnosed professionally with ASD
  2. the child is currently receiving ABA therapy at least twice per week at home.
  3. The child's family is willing to drive to Stanford University for up to 4 study appointments.

Exclusion Criteria:

  1. The child scores less than 15 on the Social Communication Questionnaire
  2. The child's family does not speak English

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): NCT03569176


Sponsors and Collaborators
Dennis Paul Wall
Investigators
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Principal Investigator: Dennis P Wall, PhD Associate Professor

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dennis Paul Wall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03569176     History of Changes
Other Study ID Numbers: IRB-34059
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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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:
mobile health, autism, ASD, mobile therapy, digital, 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