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

NCT ID: NCT03569176

Last Updated: 2024-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2018-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Autism Glass

Intervention Type 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.

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).

Group Type OTHER

Autism Glass

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dennis Paul Wall

OTHER

Sponsor Role lead

Responsible Party

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Dennis Paul Wall

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dennis P Wall, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

References

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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.

Reference Type DERIVED
PMID: 30907929 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-34059

Identifier Type: -

Identifier Source: org_study_id