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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autism Glass
Sponsored by
Dennis Paul Wall
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Autism Glass Intervention

    Crossover Control for Autism Glass

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    Change in socialization subscale scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) from baseline to 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.
    Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to 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.
    Change in NEPSY-II, Affect Recognition subscale scores from baseline to 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.
    Change in Emotion Guessing Game (EGG) scores from baseline to 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

    Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to 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.
    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.
    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.
    Change in child's emotional, behavioral, and social problems from Baseline (week 0) to Week 6 as measured by Child Behavior Checklist (CBCL).
    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.

    Full Information

    First Posted
    June 14, 2018
    Last Updated
    July 16, 2018
    Sponsor
    Dennis Paul Wall
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03569176
    Brief Title
    Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder
    Official Title
    Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    April 11, 2018 (Actual)
    Study Completion Date
    April 15, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dennis Paul Wall

    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 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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Autism Glass Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Crossover Control for Autism Glass
    Arm Type
    Other
    Arm Description
    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).
    Intervention Type
    Device
    Intervention Name(s)
    Autism 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 or during ABA therapy.
    Primary Outcome Measure Information:
    Title
    Change in socialization subscale scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) from baseline to week 6.
    Description
    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.
    Time Frame
    Baseline (week 0), Week 6
    Title
    Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) from baseline to week 6
    Description
    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.
    Time Frame
    Baseline (week 0), Week 6
    Title
    Change in NEPSY-II, Affect Recognition subscale scores from baseline to week 6
    Description
    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.
    Time Frame
    Baseline (week 0), Week 6
    Title
    Change in Emotion Guessing Game (EGG) scores from baseline to week 6
    Description
    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.
    Time Frame
    Baseline (week 0), Week 6
    Secondary Outcome Measure Information:
    Title
    Change in ASD symptoms as measured by Brief Observation of Social Communication Change (BOSCC) from baseline to week 6
    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 play based assessment that consists of two boxes filled with specific toys and takes about 12 minutes to complete.
    Time Frame
    Baseline (week 0), week 6
    Title
    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.
    Description
    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.
    Time Frame
    Baseline (week 0), week 6
    Title
    Change in child's emotional, behavioral, and social problems from Baseline (week 0) to Week 6 as measured by Child Behavior Checklist (CBCL).
    Description
    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.
    Time Frame
    Baseline (week 0), Week 6
    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.
    Time Frame
    Baseline (week 0)
    Title
    Mobilized Machine Learning Autism Risk Assessment (MARA) score of autism severity at baseline
    Description
    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.
    Time Frame
    Baseline (week 0)
    Title
    Social Communication Questionnaire (SCQ) score at baseline
    Description
    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.
    Time Frame
    Baseline (week 0)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: the child has been diagnosed professionally with ASD the child is currently receiving ABA therapy at least twice per week at home. The child's family is willing to drive to Stanford University for up to 4 study appointments. Exclusion Criteria: The child scores less than 15 on the Social Communication Questionnaire The child's family does not speak English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennis P Wall, PhD
    Organizational Affiliation
    Associate Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30907929
    Citation
    Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.
    Results Reference
    derived

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

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