Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism

NCT06058104 | Not Yet Recruiting DMC

• 1 other identifier: 60181-Stanford
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in children with Autism Spectrum Disorder (ASD). GuessWhat is a mobile application (available for free for iOS and Android) which contains a suite of games: pro-social charades, emotion guessing, and quiz. Participant families will use their personal smartphones to download the app and play it with their child according to a predetermined regimen.

Conditions

Autism; Autism Spectrum Disorder

Keywords

digital; mobile health; autism; pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in parent reported socialization based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, from baseline to week 8

  Vineland Adaptive Behavior Scales, 3rd edition (VABS-3) Socialization subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the socialization domain of the VABS-III reflects one's functioning in social situations. The socialization subscale is up to 112 items depending on age and development, where raw scores are converted to Intellectual Quotient-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 8

Secondary Outcomes (2)

• Change in Parental Stress Scale - from baseline to week 8

  Baseline (Week 0), Week 8

• Change in Emotion Recognition from baseline to week 8

  Baseline (Week 0), Week 8

Other Outcomes (1)

• mobile autism risk assessment score at baseline

  baseline (week 0)

Study Arms (2)

Charades-based mobile digital therapeutic

EXPERIMENTAL

The mobile app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parents are asked to play with their child for 15 minutes 3-4 times per week for 8 weeks.

Device: Charades based mobile digital therapeutic

Treatment as Usual

NO INTERVENTION

Participants in control group will continue their Applied Behavior Analysis therapy as usual for 8 weeks, and then will be able to cross-over to the treatment condition at week 8.

Interventions

Charades based mobile digital therapeutic DEVICE

The mobile app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parents are asked to play with their child 15 minutes 3-4 times per week for 8 weeks.

Also known as: GuessWhat

Charades-based mobile digital therapeutic

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent who is at least 18 years old of child with autism.
• Child with autism is between 3 and 12 years old at time of baseline data collection.
• A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.

You may not qualify if:

• Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
• Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
• Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Dennis P Wall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiti Dunlap, MRes

CONTACT

650-497-9214; kdunlap2@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The parent will know whether their child is receiving the treatment or not as they administer the treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will use block randomization stratified by sex to assign participants to the group where they will use the treatment immediately for 8 weeks or the cross over waitlist control, where they will be able to use the treatment after 8 weeks.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)