Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

NCT04909710 | Withdrawn

• 1 other identifier: IRB 39562
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorder; Autism

Keywords

digital; mobile; autism

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline (Week 0), Week 12

• Mobile Application Usage-Total games started.

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

  Week 12

Secondary Outcomes (2)

• 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 Arms (2)

Autism Case Group

EXPERIMENTAL

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.

Other: Mobile Game System for Potential Treatment of Developmental Delays

Neurotypical Sibling Control Group

OTHER

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.

Other: Mobile Game System for Potential Treatment of Developmental Delays

Interventions

Mobile Game System for Potential Treatment of Developmental Delays 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.

Autism Case Group; Neurotypical Sibling Control Group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dennis P Wall, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

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

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 2, 2021
• Study Start: July 15, 2021
• Primary Completion: June 1, 2025
• Study Completion: February 28, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 1 year after study completion

Locations

US (1)