A Lead-in Study Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

A Lead-in Study Evaluating Mobile Game Based Therapy Among Children With Autism

The following study aims to assess the efficacy, safety data, and best outcome measurements of the mobile game platform, GuessWhat, in delivering behavioral therapy to 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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Device: GuessWhat Mobile App

Detailed Description

The following study aims to understand the efficacy and safety of the mobile game platform, GuessWhat, in delivering behavioral therapy to 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. 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 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

1. Parent is unable to read English.
2. Parent does not have an Android or iOS smartphone compatible with GuessWhat App--the app will be available on Android after further development and we will notify interested families when it becomes available.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The GuessWhat 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. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.	Device: GuessWhat Mobile App; The GuessWhat 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. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.
No Intervention: Treatment as Usual; Participants in control group will continue their treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parent Reported Socialization Based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, From Baseline to Week 4	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 IQ-type standard scores with mean 100 and standard deviation of 15, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. The range for each subscale is 20 to 140.	Baseline (Week 0), Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parental Stress Scale - From Baseline to Week 4	The Parental Stress Scale is an 18-item parent report scale that evaluates the extent of parent stress. Scores range from 18-90, where higher scores indicate a higher level of Parental stress. Parents completed this survey, but were not considered to be enrolled in the study.	Baseline (Week 0), Week 4
GuessWhat App Usage Data	App usage data by participants (children) comprised of number of MojiMatch and Charades Games started.	Baseline through week 4 (assessed at week 4)
Change in Emotion Recognition From Baseline to Week 4	Study team used an image based emotion recognition task where participants (children) will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants select 1 of 8 available Ekman emotion labels for 16 facial emotional image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs. Scores range from 0 (no emotional image stimuli correctly identified) to 16 (all correctly identified).	Baseline (Week 0), Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mobile autism risk assessment score at baseline	Study team will use 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)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Library of Medicine (NLM)
• Investigators: Principal Investigator: Dennis P Wall, PhD, Stanford University

Publications and helpful links

Helpful Links

• study sign up page
• GuessWhat Website

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: autism; intervention; digital health; mhealth; behavioral therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 60181; 5R01LM013364-03 (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; ICF

Drug and device information, study documents

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