Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- 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
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •(1) Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
Arms & Interventions
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.
Intervention: Mobile Game System for Potential Treatment of Developmental Delays (Other)
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.
Intervention: Mobile Game System for Potential Treatment of Developmental Delays (Other)
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)
Investigators
Dennis Paul Wall
Associate Professor
Stanford University