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Clinical Trials/NCT04909710
NCT04909710
Enrolling By Invitation
Not Applicable

Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Stanford University1 site in 1 country300 target enrollmentJuly 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Stanford University
Enrollment
300
Locations
1
Primary Endpoint
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver
Status
Enrolling By Invitation
Last Updated
3 years ago

Overview

Brief Summary

The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).

Registry
clinicaltrials.gov
Start Date
July 15, 2021
End Date
February 28, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dennis Paul Wall

Associate Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Parent or primary caregiver over 18 of a child with autism between ages of 2 and
  • Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

Exclusion Criteria

  • Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.

Outcomes

Primary Outcomes

Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver

Time Frame: Baseline (Week 0), Week 12

The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (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.

Mobile Application Usage-Total games started.

Time Frame: Week 12

App usage data by participants (children) comprised of total number of MojiMatch plus Charades Games started.

Secondary Outcomes

  • Change in parent reported social responsiveness from week 0 to week 12(Baseline (Week 0), Week 12)
  • Change in mobile autism risk assessment score from week 0 to week 12(Baseline (Week 0), Week 12)

Study Sites (1)

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