NCT04450641

Brief Summary

The following study aims to understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game 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. The app will walk participants through a variety of charades style games. The interactive games will be video recorded and all data are transferred securely to the Wall Lab for analysis. This study is enrolling parents of children with ASD who are at least 18 years of age and have a child between 3-12 years old. Parents are asked to complete questionnaires before and after playing the GuessWhat game with their child 3-4 times per week for 4 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

June 24, 2020

Last Update Submit

February 1, 2021

Conditions

Keywords

digitalmobile healthgameautismtechnologytherapy

Outcome Measures

Primary Outcomes (2)

  • Change in parent reported social responsiveness from week 0 to week 4

    The Social Responsiveness Scale-2 is a 65-item measure where parents 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 4

  • Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4

    Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) 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 32 items, where raw scores are converted to 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 4

Secondary Outcomes (3)

  • GuessWhat App Usage Data

    4 weeks

  • Parent reported feedback

    Week 4

  • Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4

    Baseline (Week 0), Week 4

Other Outcomes (1)

  • Baseline Parent Reported Social Communication

    Baseline (Week 0)

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment group used GuessWhat during the 4 week intervention period.

Other: GuessWhat Mobile Application

Control

OTHER

Participants in control group received standard treatment as usual.

Other: GuessWhat Mobile Application

Interventions

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.

ControlTreatment

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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 not able to read or speak English
  • Parent does not have an Android or iOs smartphone compatible with GuessWhat App

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Dennis P Wall, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking. All participants received the same condition and asked to play a mobile app. Participants who did not play the app during piloting were asked to complete study measures pre and post. These measures were compared against participants who did play the app.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

October 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations