Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism

NCT ID: NCT06058104

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

The following study aims to understand the efficacy of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. 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. The study will enroll parents who are at least 18 years old and have a child between 3 and 12 years old with a formal ASD diagnosis. Parents will be asked to complete two clinical outcome measure questionnaires immediately prior to and up to 1 week after playing GuessWhat with their child 3 times per week for 8 weeks.

Conditions

Autism; Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Charades-based mobile digital therapeutic

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.

Group Type: EXPERIMENTAL

Charades based mobile digital therapeutic

Intervention Type: 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.

Treatment as Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Charades based mobile digital therapeutic

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.

Intervention Type: DEVICE

Other Intervention Names

GuessWhat

Eligibility Criteria

Inclusion Criteria

1. Parent who is at least 18 years old of child with autism.

2. Child with autism is between 3 and 12 years old at time of baseline data collection.

3. 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.

Exclusion Criteria

1. Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)

2. Parent does not have an Android or iOS smartphone compatible with GuessWhat App.

3. Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Paul Wall

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis P Wall, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Kaiti Dunlap, MRes

Role: CONTACT

kdunlap2@stanford.edu

650-497-9214

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

60181-Stanford

Identifier Type: -

Identifier Source: org_study_id