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Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Not Applicable
Conditions
Autism Spectrum Disorder
Autism
Interventions
Other: Mobile Game System for Potential Treatment of Developmental Delays
Registration Number
NCT04909710
Lead Sponsor
Stanford University
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
300
Inclusion Criteria
  1. Parent or primary caregiver over 18 of a child with autism between ages of 2 and 8.
  2. Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.
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Exclusion Criteria
  1. Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Neurotypical Sibling Control GroupMobile Game System for Potential Treatment of Developmental DelaysNeurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
Autism Case GroupMobile Game System for Potential Treatment of Developmental DelaysAutistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
Primary Outcome Measures
NameTimeMethod
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/CaregiverBaseline (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.Week 12

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

Secondary Outcome Measures
NameTimeMethod
Change in parent reported social responsiveness from week 0 to week 12Baseline (Week 0), Week 12

The Social Responsiveness Scale-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).

Change in mobile autism risk assessment score from week 0 to week 12Baseline (Week 0), Week 12

A level 2 screening tool that has been validated in several studies and that uses a brief parent questionnaire with a 2 minute home video to generate a classification score that indicates severity of the autism phenotype (ranging from no autistic symptoms to severe autism) as well as confidence in the classification.

Trial Locations

Locations (1)

Stanford University

🇺🇸

Stanford, California, United States

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