Piloting a Mobile Game for Behavioral Therapy
Primary Purpose
Autism Spectrum Disorder, Autism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GuessWhat Mobile Application
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorder focused on measuring digital, mobile health, game, autism, technology, therapy
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 not able to read or speak English
- Parent does not have an Android or iOs smartphone compatible with GuessWhat App
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment
Control
Arm Description
Treatment group used GuessWhat during the 4 week intervention period.
Participants in control group received standard treatment as usual.
Outcomes
Primary Outcome Measures
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).
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.
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 parent reported communication 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) 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04450641
Brief Title
Piloting a Mobile Game for Behavioral Therapy
Official Title
A Gamified Mobile Platform for Improving Social Communication in Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
digital, mobile health, game, autism, technology, therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
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.
Allocation
Non-Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment group used GuessWhat during the 4 week intervention period.
Arm Title
Control
Arm Type
Other
Arm Description
Participants in control group received standard treatment as usual.
Intervention Type
Other
Intervention Name(s)
GuessWhat Mobile Application
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 social responsiveness from week 0 to week 4
Description
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).
Time Frame
Baseline (Week 0), Week 4
Title
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Description
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.
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
4 weeks
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 parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Description
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.
Time Frame
Baseline (Week 0), Week 4
Other Pre-specified Outcome Measures:
Title
Baseline Parent Reported Social Communication
Description
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.
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 not able to read or speak English
Parent does not have an Android or iOs smartphone compatible with GuessWhat App
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
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://guesswhat.stanford.edu
Description
Study Website
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Piloting a Mobile Game for Behavioral Therapy
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