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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01LM013364-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Library of Medicine (NLM) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
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| Treatment as Usual | No Intervention | Participants in control group will continue their treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GuessWhat Mobile App | Device | 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. |
| 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 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. | Baseline (Week 0), Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0), Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P Wall, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| Label | URL |
|---|---|
| study sign up page | View source |
| GuessWhat Website | View source |
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within 1 year after study completion
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Participants were recruited between June 1, 2021 and July 1, 2022 using emails and online research listings.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Treatment as Usual | Participants in control group will continue their treatment as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed follow-up survey at week 4
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed follow-up survey at week 4 | Posted | Mean | Standard Error | score on a scale | Baseline (Week 0), Week 4 |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaiti Dunlap, Clinical Research Coordinator | Stanford University | 650-497-9214 | kdunlap2@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2023 | Jul 15, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 7, 2023 | Sep 1, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| GuessWhat App Usage Data | App usage data by participants (children) comprised of number of MojiMatch and Charades Games started. | 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). | Baseline (Week 0), Week 4 |
| Protocol Violation |
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| BG001 | Treatment as Usual | Participants in control group will continue their treatment as usual. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Some participants may be counted twice as we allowed for multi-select in out form for race/ethnicity. | Count of Participants | Participants |
|
| Vineland Adaptive Behavior Scales-3 Socialization Subscale Standard Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Parental Stress Scale Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Mobile Autism Risk Assessment | The Mobile Autism Risk Assessment (MARA) is an electronically administered, 7-question autism spectrum disorder (ASD) screening tool to triage those at highest risk for ASD. Scores range from -10 to 10, with negative scores indicating high risk, and positive scores suggesting low risk for ASD. | Mean | Full Range | score on a scale |
|
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.
| OG001 | Treatment as Usual | Participants in control group will continue their treatment as usual. |
|
|
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| Secondary | 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. | Participants who completed follow-up survey at week 4 | Posted | Mean | Standard Error | units on a scale | Baseline (Week 0), Week 4 |
|
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|
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| Secondary | GuessWhat App Usage Data | App usage data by participants (children) comprised of number of MojiMatch and Charades Games started. | Participants with available data. Only the Treatment Group is included in the analysis, as the Treatment as Usual Group did not use the app. | Posted | Mean | Standard Deviation | number of games | Baseline through week 4 (assessed at week 4) |
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|
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| Secondary | 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). | Participants with available data. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Week 0), Week 4 |
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|
| 0 |
| 322 |
| 0 |
| 322 |
| 0 |
| 322 |
| EG001 | Treatment as Usual | Participants in control group will continue their treatment as usual. | 0 | 219 | 0 | 219 | 0 | 219 |
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