Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

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 Overview

• Status: Enrolling by invitation
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Other: Mobile Game System for Potential Treatment of Developmental Delays

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaiti Dunlap, MRes; Phone Number: 650-497-9214; Email: kaiti.dunlap@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Contact: Kaiti Dunlap, MRes; Phone Number: 650-497-9214; Email: kaiti.dunlap@stanford.edu
      • Principal Investigator: Dennis P Wall, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Parent or primary caregiver over 18 of a child with autism between ages of 2 and 8.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Mobile Game System for Potential Treatment of Developmental Delays; This mobile game system is designed to generate valuable data from video, image, and usage 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.
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.	Other: Mobile Game System for Potential Treatment of Developmental Delays; This mobile game system is designed to generate valuable data from video, image, and usage 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary change in parent/caregiver reported socialization on the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12	Study investigators will preliminarily measure change in the Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver Comprehensive form. This will allow study team to understand if use of the mobile app as treatment is feasible. Scores from the socialization domain of the VABS-2 reflects one's functioning in social situations. 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	Time (in seconds) of app use across the 12 weeks.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent/caregiver reported social responsiveness from week 0 to week 12	The Social Responsiveness Scale-2 is a 65-item measure where parents/caregivers 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 severitySocial 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).	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/caregiver 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
Video Based Feature Analysis	Shared videos will be evaluated for proper game play and enjoyment with the game across the 12 week period of the intervention.	Week 12
Change in Parent/Caregiver Confidence and Resources from baseline to week 12	Two 5 item questions regarding parent/caregiver confidence in their ability to manage their child's behaviors and adequacy of resources to manage their child's behaviors.	Baseline (Week 0), Week 12
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to week 12	The PSI-SF is a 36-item parent report scale that evaluates the extent and source of parent stress in the form of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36-180 with lower scores representing less parent stress.	Baseline (Week 0), Week 12
Engagement in gameplay across the 12 week period	The Fun ToolKit and Child Engagement Scale will be adapted and combined to assess children's engagement and enjoyment while playing the app.	Week 12
Change in Emotion Recognition from baseline to week 12	Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will select 1 of 8 available Ekman emotion labels for 21 emotional face image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs.	Baseline (Week 0), Week 12
Changes in parent/caregiver reported eye contact and joint attention from week 0 to week 12	Parents/caregivers will rate their child's socially motivated eye contact and joint attention skills pre and post. This will be a 10 item measure.	Baseline (Week 0), Week 12
Change in NIH-Emotion Toolbox from baseline to Week 12	The NIH toolbox for emotion was developed to create a standardized, comprehensive, and concise battery of tests that can recognize the full spectrum of emotional experiences and their impacts on health and wellbeing. The NIH Toolbox for emotion includes 3 subdomains: negative affect, psychological well-being, and social relationships for children 3-7 years old. For the age range of 8-12 proxy measures are available for the same subdomains.	Baseline (Week 0), Week 12

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Library of Medicine (NLM)

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): February 28, 2026

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: autism; mobile; digital
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: IRB 39562; 5R01LM013364 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Within 1 year after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No