Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

NCT ID: NCT04909710

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2026-02-28

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder Autism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

NONE

Study Groups

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Autism Case Group

Autistic 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.

Group Type EXPERIMENTAL

Mobile Game System for Potential Treatment of Developmental Delays

Intervention Type OTHER

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.

Neurotypical Sibling Control Group

Neurotypical 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.

Group Type OTHER

Mobile Game System for Potential Treatment of Developmental Delays

Intervention Type OTHER

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.

Interventions

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Mobile 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Dennis Paul Wall

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis P Wall, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 39562

Identifier Type: -

Identifier Source: org_study_id

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