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Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04909710
Enrollment
0
Registered
2021-06-02
Start date
2021-07-15
Completion date
2026-02-28
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism, Autism Spectrum Disorder

Keywords

digital, mobile, autism

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).

Interventions

OTHERMobile Game System for Potential Treatment of Developmental Delays

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

1. Parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old. 2. Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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 12The 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 12App usage data by participants (children) comprised of total number of MojiMatch plus Charades Games started.

Secondary

MeasureTime frameDescription
Change in parent reported social responsiveness from week 0 to week 12Baseline (Week 0), Week 12The 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 12A 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026