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we are suspending this study until we have continued funding.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in parent reported social responsiveness from week 0 to 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). |
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Inclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Dennis P Wall, PhD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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Within 1 year after study completion
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.
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| Baseline (Week 0), Week 12 |
| Change in mobile autism risk assessment score from week 0 to 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. | Baseline (Week 0), Week 12 |