Evaluating Efficacy of GuessWhat Mobile App Therapy for Children With Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Mobile Game Based Therapy Among Children With Autism, A Randomized Clinical Trial.

Conditions
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Autism, Autism Spectrum Disorder

Intervention / Treatment
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* Device: GuessWhat Mobile App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* 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.<br>|
| No Intervention: Treatment as Usual<br>Participants in control group will continue their treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (Week 0), Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GuessWhat App Usage Data | App usage data comprised of game decks selected, number of game sessions started, ended, and shared. | Week 4 | 
| 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. | Week 4 | 
| 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. | Baseline (Week 0), Week 4 | 
| 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. | Baseline (Week 0), Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital health, mhealth, autism, intervention, behavioral therapy