- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450641
Piloting a Mobile Game for Behavioral Therapy
February 1, 2021 updated by: Dennis Paul Wall, Stanford University
A Gamified Mobile Platform for Improving Social Communication in Children With Autism
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
186
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 not able to read or speak English
- Parent does not have an Android or iOs smartphone compatible with GuessWhat App
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
Treatment group used GuessWhat during the 4 week intervention period.
|
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.
|
OTHER: Control
Participants in control group received standard treatment as usual.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parent reported social responsiveness from week 0 to week 4
Time Frame: Baseline (Week 0), 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
Time Frame: Baseline (Week 0), 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 4
|
GuessWhat App Usage Data
Time Frame: 4 weeks
|
App usage data comprised of game decks selected, number of game sessions started, ended, and shared.
|
4 weeks
|
Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Time Frame: Baseline (Week 0), Week 4
|
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Communication subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents.
Scores from the communication domain of the VABS-III reflects The communication 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Parent Reported Social Communication
Time Frame: Baseline (Week 0)
|
The Social Communication Questionnaire (SCQ) screens for autism in children over 4:0 years in age.
Parents are asked 40 Yes/No questions and the resulting score is out of 39 (the first question is not associated with a numerical value).
The SCQ assesses a child's communication skills and social functioning.
It takes less than 10 minutes to complete and is administered by clinical research coordinators to parents of children during the phone screen to participants who have already completed the online screening questionnaire.
A score of 15 or above is indicative of autism and is required to be eligible in the research study.
|
Baseline (Week 0)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2019
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (ACTUAL)
June 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 1, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on GuessWhat Mobile Application
-
Stanford UniversityRecruitingAutism Spectrum Disorder | AutismUnited States
-
Stanford UniversityEnrolling by invitationAutism Spectrum Disorder | AutismUnited States
-
Mississippi State UniversityRecruiting
-
Mississippi State UniversityAssociation for contextual behavioral scienceNot yet recruitingHealth-Related BehaviorUnited States
-
George Washington UniversityMedia RezRecruiting
-
University of ReginaCompletedStress | Dementia | Caregiver BurdenCanada
-
University Hospitals Cleveland Medical CenterCompleted
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting
-
University of CadizRecruiting
-
Boston Medical CenterBoston Medical Center Food KitchenWithdrawnDiabetes Mellitus, Type 2 | Pre DiabetesUnited States