Autism, Autism Spectrum Disorder
Conditions
Keywords
digital health, mhealth, autism, intervention, behavioral therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGuessWhat Mobile App
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.
Sponsors
National Library of Medicine (NLM)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. Parent who is at least 18 years old of child with autism. 2. Child with autism is between 3 and 12 years old at time of baseline data collection.
Exclusion criteria
1. Parent is unable to read English. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Week 0), 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parental Stress Scale - From Baseline to Week 4 | Baseline (Week 0), 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. |
| GuessWhat App Usage Data | Baseline through week 4 (assessed at week 4) | App usage data by participants (children) comprised of number of MojiMatch and Charades Games started. |
| Change in Emotion Recognition From Baseline to Week 4 | Baseline (Week 0), 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between June 1, 2021 and July 1, 2022 using emails and online research listings.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 127 |
| Treatment as Usual Participants in control group will continue their treatment as usual. | 149 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 176 | 65 |
| Overall Study | Protocol Violation | 0 | 5 |
| Overall Study | Withdrawal by Subject | 19 | 0 |
Baseline characteristics
| Characteristic | Treatment | Total | Treatment as Usual |
|---|---|---|---|
| Age, Categorical <=18 years | 127 Participants | 276 Participants | 149 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.89 years | 7.66 years | 7.47 years |
| Mobile Autism Risk Assessment | -3.39 score on a scale | -3.62 score on a scale | -3.82 score on a scale |
| Parental Stress Scale Score | 47.06 score on a scale STANDARD_DEVIATION 9.13 | 47.54 score on a scale STANDARD_DEVIATION 9.4 | 47.95 score on a scale STANDARD_DEVIATION 9.81 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 7 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 37 Participants | 18 Participants |
| Race/Ethnicity, Customized Caucasian/White | 47 Participants | 94 Participants | 47 Participants |
| Race/Ethnicity, Customized East Asian | 7 Participants | 20 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants | 41 Participants | 23 Participants |
| Race/Ethnicity, Customized Middle Eastern | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized South Asian | 5 Participants | 20 Participants | 15 Participants |
| Race/Ethnicity, Customized Unknown / Not Listed | 34 Participants | 76 Participants | 42 Participants |
| Sex: Female, Male Female | 33 Participants | 64 Participants | 31 Participants |
| Sex: Female, Male Male | 94 Participants | 212 Participants | 118 Participants |
| Vineland Adaptive Behavior Scales-3 Socialization Subscale Standard Score | 72.30 score on a scale STANDARD_DEVIATION 16.68 | 69.42 score on a scale STANDARD_DEVIATION 17.84 | 66.97 score on a scale STANDARD_DEVIATION 18.42 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 322 | 0 / 219 |
| other Total, other adverse events | 0 / 322 | 0 / 219 |
| serious Total, serious adverse events | 0 / 322 | 0 / 219 |
Outcome results
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.
Time frame: Baseline (Week 0), Week 4
Population: Participants who completed follow-up survey at week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | 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 score on a scale | Standard Error 0.98 |
| 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 | .23 score on a scale | Standard Error 0.96 |
p-value: 0.4195% CI: [-0.21, 0.27]t-test, 1 sided
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).
Time frame: Baseline (Week 0), Week 4
Population: Participants with available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Emotion Recognition From Baseline to Week 4 | -.37 score on a scale | Standard Deviation 4.34 |
| Treatment as Usual | Change in Emotion Recognition From Baseline to Week 4 | -1.12 score on a scale | Standard Deviation 3.42 |
p-value: 0.0995% CI: [-0.09, 0.47]t-test, 1 sided
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.
Time frame: Baseline (Week 0), Week 4
Population: Participants who completed follow-up survey at week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Change in Parental Stress Scale - From Baseline to Week 4 | -5.18 units on a scale | Standard Error 0.76 |
| Treatment as Usual | Change in Parental Stress Scale - From Baseline to Week 4 | -7.01 units on a scale | Standard Error 1.17 |
p-value: 0.09595% CI: [-0.08, 0.39]t-test, 1 sided
Secondary
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)
Population: Participants with available data. Only the Treatment Group is included in the analysis, as the Treatment as Usual Group did not use the app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | GuessWhat App Usage Data | 15.77 number of games | Standard Deviation 25.43 |