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

NCT03569176 | Completed Results

• 1 other identifier: IRB-34059
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder

Keywords

mobile health, autism, ASD, mobile therapy, digital, wearable computing, technology

Outcome Measures

Primary Outcomes (3)

• 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.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.

  Baseline (week 0), Week 6

• 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. Social 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).

  Baseline (week 0), Week 6

• 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, higher scores indicated better emotion recognition, where scores can range from 0 to 40.

  Baseline (week 0), Week 6

Secondary Outcomes (4)

• Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6

  Baseline (week 0), week 6

• 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.

  Baseline (week 0), week 6

• 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.

  Baseline (week 0), Week 6

• Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6

  Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6

Study Arms (2)

Autism Glass Intervention

EXPERIMENTAL

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

Crossover Control for Autism Glass

OTHER

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

Interventions

Autism Glass DEVICE

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.

Autism Glass Intervention; Crossover Control for Autism Glass

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dennis Paul Wall: lead

Related Publications (1)

• 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.

  PMID: 30907929 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Dennis P. Wall
• Organization: Stanford University

dpwall@stanford.edu

650-497-9214

Study Officials

• Dennis P Wall, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: November 1, 2016
• Primary Completion: April 11, 2018
• Study Completion: April 15, 2018
• Last Updated: December 20, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-11