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Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

Primary Purpose

Autism, Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GuessWhat Mobile App
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring digital health, mhealth, autism, intervention, behavioral therapy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Treatment as Usual

Arm Description

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.

Participants in control group will continue their treatment as usual.

Outcomes

Primary Outcome Measures

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--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.

Secondary Outcome Measures

GuessWhat App Usage Data
App usage data comprised of game decks selected, number of game sessions started, ended, and shared.
Parent reported feedback
Qualitative survey delivered to parent participants at Week 4 to understand preferred games, overall feedback including likes and dislikes, any technical issues they experienced or challenges in using the app.
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.
Change in Emotion Recognition from baseline to week 4
Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will 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.

Full Information

First Posted
February 1, 2021
Last Updated
December 12, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04739982
Brief Title
Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism
Official Title
Evaluating Mobile Game Based Therapy Among Children With Autism, A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The following study aims to understand the efficacy 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.
Detailed Description
The following study aims to understand the efficacy 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder
Keywords
digital health, mhealth, autism, intervention, behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Participants in control group will continue their treatment as usual.
Intervention Type
Device
Intervention Name(s)
GuessWhat Mobile App
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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--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.
Time Frame
Baseline (Week 0), Week 4
Secondary Outcome Measure Information:
Title
GuessWhat App Usage Data
Description
App usage data comprised of game decks selected, number of game sessions started, ended, and shared.
Time Frame
Week 4
Title
Parent reported feedback
Description
Qualitative survey delivered to parent participants at Week 4 to understand preferred games, overall feedback including likes and dislikes, any technical issues they experienced or challenges in using the app.
Time Frame
Week 4
Title
Change in Parental Stress Scale - from baseline to week 4
Description
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.
Time Frame
Baseline (Week 0), Week 4
Title
Change in Emotion Recognition from baseline to week 4
Description
Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will 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.
Time Frame
Baseline (Week 0), Week 4
Other Pre-specified Outcome Measures:
Title
mobile autism risk assessment score at baseline
Description
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.
Time Frame
Baseline (Week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yordan Penev, MSc
Phone
(650) 497 - 9214
Email
ypenev@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kaiti Dunlap, MRes
Phone
650-497-9214
Email
kaiti.dunlap@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P Wall, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaiti Dunlap, MRes
Phone
650-497-9214
Email
kaiti.dunlap@stanford.edu
First Name & Middle Initial & Last Name & Degree
Dennis P Wall, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
within 1 year after study completion
Links:
URL
https://redcap.link/AutismSmartphoneStudy
Description
study sign up page
URL
https://guesswhat.stanford.edu
Description
GuessWhat Website

Learn more about this trial

Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

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