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N/A N=71 Randomized Double-blind Treatment

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

Autism Spectrum Disorder

Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6. — 68.75; 70.40; 71.72; 68.6 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Autism Glass (Device)
Age
Pediatric · 6+ yrs
Sex
All
Sponsor
Dennis Paul Wall
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
68.75; 70.40; 71.72; 68.6
PRIMARY
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6
80.68; 80.76; 78.4; 81.79
PRIMARY
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6
22.80; 24.74; 30.03; 26.88
SECONDARY
Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6
SECONDARY
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.
71.45; 74.63; 72.29; 74.48
SECONDARY
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.
65.95; 69.04; 63.77; 65.55
SECONDARY
Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6
.099; -.068

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

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03569176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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