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

NCT04739982 | Completed Results FDA Device

• 2 other identifiers: 601815R01LM013364-03
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Autism Spectrum Disorder

Keywords

digital health; mhealth; autism; intervention; behavioral therapy

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 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 Outcomes (3)

• Change in Parental Stress Scale - From Baseline to Week 4

  Baseline (Week 0), Week 4

• GuessWhat App Usage Data

  Baseline through week 4 (assessed at week 4)

• Change in Emotion Recognition From Baseline to Week 4

  Baseline (Week 0), Week 4

Study Arms (2)

Treatment

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Participants in control group will continue their treatment as usual.

Interventions

GuessWhat Mobile App DEVICE

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.

Treatment

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• 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.

You may not qualify if:

• Parent is unable to read English.
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Links

• study sign up page
• GuessWhat Website

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Kaiti Dunlap, Clinical Research Coordinator
• Organization: Stanford University

kdunlap2@stanford.edu

650-497-9214

Study Officials

• Dennis P Wall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: July 7, 2021
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: within 1 year after study completion

Locations

US (1)