Clinical trial NCT03569176: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: mobile health, autism, ASD, mobile therapy, digital, wearable computing, technology
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
timeFrame: Baseline (week 0), Week 6
measure: Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6
timeFrame: Baseline (week 0), Week 6
measure: Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6
timeFrame: Baseline (week 0), Week 6
Secondary outcomes:
measure: Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6
timeFrame: Baseline (week 0), week 6
measure: 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.
timeFrame: Baseline (week 0), week 6
measure: Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score.
timeFrame: Baseline (week 0), Week 6
measure: Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6
timeFrame: Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Dennis P Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.