An interventional study of GuessWhat Mobile App in Autism and Autism Spectrum Disorder, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Stanford University · Not applicable, Interventional, and Other
The following study aims to assess the efficacy, safety data, and best outcome measurements 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 following study aims to understand the efficacy and safety 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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 541 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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
Participants in control group will continue their 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.
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 with mean 100 and standard deviation of 15, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. The range for each subscale is 20 to 140.
Time frame: Baseline (Week 0), 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. Parents completed this survey, but were not considered to be enrolled in the study.
Time frame: Baseline (Week 0), Week 4
GuessWhat App Usage Data
App usage data by participants (children) comprised of number of MojiMatch and Charades Games started.
Time frame: Baseline through week 4 (assessed at week 4)
Change in Emotion Recognition From Baseline to Week 4
Study team used an image based emotion recognition task where participants (children) will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants 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. Scores range from 0 (no emotional image stimuli correctly identified) to 16 (all correctly identified).
Time frame: Baseline (Week 0), Week 4
Participants were recruited between June 1, 2021 and July 1, 2022 using emails and online research listings.
| Milestone | Treatment | Treatment as Usual |
|---|---|---|
| Started | 322 | 219 |
| Completed week 4 survey | 127 | 149 |
| Completed | 127 | 149 |
| Not completed | 195 | 70 |
| Withdrew: Lost to follow-up | 176 | 65 |
| Withdrew: Withdrawal by subject | 19 | 0 |
| Withdrew: Protocol violation | 0 | 5 |
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 with mean 100 and standard deviation of 15, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning. The range for each subscale is 20 to 140.
| score on a scale | Treatment | Treatment as Usual |
|---|---|---|
| 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 | .56 ± .98 | .23 ± .96 |
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. Parents completed this survey, but were not considered to be enrolled in the study.
| units on a scale | Treatment | Treatment as Usual |
|---|---|---|
| Change in Parental Stress Scale - From Baseline to Week 4 | -5.18 ± .76 | -7.01 ± 1.17 |
App usage data by participants (children) comprised of number of MojiMatch and Charades Games started.
| number of games | Treatment |
|---|---|
| GuessWhat App Usage Data | 15.77 ± 25.43 |
Study team used an image based emotion recognition task where participants (children) will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants 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. Scores range from 0 (no emotional image stimuli correctly identified) to 16 (all correctly identified).
| score on a scale | Treatment | Treatment as Usual |
|---|---|---|
| Change in Emotion Recognition From Baseline to Week 4 | -.37 ± 4.34 | -1.12 ± 3.42 |
Collected over 8 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/322 (0%) | 0/322 (0%) | 0/322 (0%) |
| Treatment as Usual | 0/219 (0%) | 0/219 (0%) | 0/219 (0%) |
Participants who completed follow-up survey at week 4
| Age, Categorical(Participants) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| <=18 years | 127 | 149 | 276 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 7.89 (3 to 12) | 7.47 (3 to 12) | 7.66 (3 to 12) |
| Sex: Female, Male(Participants) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Female | 33 | 31 | 64 |
| Male | 94 | 118 | 212 |
| Race/Ethnicity, Customized(Participants) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 6 | 7 |
| Black or African American | 19 | 18 | 37 |
| East Asian | 7 | 13 | 20 |
| Hispanic or Latino | 18 | 23 | 41 |
| Middle Eastern | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 2 | 2 | 4 |
| South Asian | 5 | 15 | 20 |
| Unknown / Not Listed | 34 | 42 | 76 |
| Caucasian/White | 47 | 47 | 94 |
| Vineland Adaptive Behavior Scales-3 Socialization Subscale Standard Score(score on a scale) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 72.30 ± 16.68 | 66.97 ± 18.42 | 69.42 ± 17.84 |
| Parental Stress Scale Score(score on a scale) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 47.06 ± 9.13 | 47.95 ± 9.81 | 47.54 ± 9.40 |
| Mobile Autism Risk Assessment(score on a scale) | Treatment | Treatment as Usual | Total |
|---|---|---|---|
| Mean | -3.39 (-9.28 to 6.434) | -3.82 (-9.28 to 5.684) | -3.62 (-9.28 to 6.434) |
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Plan to share: Yes
Supporting information: Study protocol, Icf
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