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Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

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ClinicalTrials.gov Identifier: NCT04739982
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Dennis Paul Wall, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder Device: GuessWhat Mobile App Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Mobile Game Based Therapy Among Children With Autism, A Randomized Clinical Trial.
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: Baseline (Week 0), 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 :
  1. GuessWhat App Usage Data [ Time Frame: Week 4 ]
    App usage data comprised of game decks selected, number of game sessions started, ended, and shared.

  2. Parent reported feedback [ Time Frame: Week 4 ]
    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.

  3. Change in Parental Stress Scale - from baseline to week 4 [ Time Frame: Baseline (Week 0), 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.

  4. Change in Emotion Recognition from baseline to week 4 [ Time Frame: Baseline (Week 0), 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.


Other Outcome Measures:
  1. mobile autism risk assessment score at baseline [ Time Frame: Baseline (Week 0) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739982


Contacts
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Contact: Yordan Penev, MSc (650) 497 - 9214 ypenev@stanford.edu
Contact: Kaiti Dunlap, MRes 650-497-9214 kaiti.dunlap@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Kaiti Dunlap, MRes    650-497-9214    kaiti.dunlap@stanford.edu   
Principal Investigator: Dennis P Wall, PhD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Dennis P Wall, PhD Stanford University
  Study Documents (Full-Text)

Documents provided by Dennis Paul Wall, Stanford University:
Informed Consent Form  [PDF] March 15, 2022

More Information
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Additional Information:

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Responsible Party: Dennis Paul Wall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04739982    
Other Study ID Numbers: 60181
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: within 1 year after study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dennis Paul Wall, Stanford University:
digital health
mhealth
autism
intervention
behavioral therapy
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders