AutismNCT06058104
Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism
A study testing Charades based mobile digital therapeutic in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial summary
The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in children with Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Charades based mobile digital therapeutic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.
Who cannot join
- Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
- Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
- Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating Efficacy of a Digital Game Based Therapeutic for Improving Socialization Outcomes in Autistic Children, A Randomized Clinical Trial.
The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in 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.
Read the detailed description
The following study aims to understand the efficacy of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. 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 8 weeks.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Charades based mobile digital therapeutic
- Keywords
- digital, mobile health, autism, pediatrics
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charades based mobile digital therapeuticDevice
Also called GuessWhat
The mobile 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. Parents are asked to play with their child 15 minutes 3-4 times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Charades-based mobile digital therapeutic | Experimental | The mobile 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. Parents are asked to play with their child for 15 minutes 3-4 times per week for 8 weeks. Receives: Device: Charades based mobile digital therapeutic |
| Treatment as Usual | No intervention | Participants in control group will continue their Applied Behavior Analysis therapy as usual for 8 weeks, and then will be able to cross-over to the treatment condition at week 8. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent reported socialization based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, from baseline to week 8
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 Intellectual Quotient-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.
Measured: Baseline (Week 0), Week 8
Secondary outcomes (2)
Change in Parental Stress Scale - from baseline to week 8
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.
Measured: Baseline (Week 0), Week 8
Change in Emotion Recognition from baseline to week 8
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.
Measured: Baseline (Week 0), Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will use block randomization stratified by sex to assign participants to the group where they will use the treatment immediately for 8 weeks or the cross over waitlist control, where they will be able to use the treatment after 8 weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Paul Wall, Stanford University
- Investigators
- Dennis P Wall, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058104
- Sponsor's protocol ID
- 60181-Stanford
- Status last verified
- May 2025
- First submitted
- 15 Sep 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy of a Digital Game Based Therapeutic for Improving Socialization Outcomes in Autistic Children, A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06058104
- Acronym / sponsor ID
- 60181-Stanford
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- digital, mobile health, autism, pediatrics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The following study aims to assess the efficacy of the game-based digital therapeutic, GuessWhat, in improving adaptive socialization skills in 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 of the digital therapeutic, GuessWhat, in improving socialization outcomes in children with Autism Spectrum Disorder (ASD) after regular use over 8 weeks. We will use a cross-over, waitlist control design to examine outcomes after 8 weeks. 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 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- We will use block randomization stratified by sex to assign participants to the group where they will use the treatment immediately for 8 weeks or the cross over waitlist control, where they will be able to use the treatment after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Charades-based mobile digital therapeutic | Experimental | Device: Charades based mobile digital therapeuticThe mobile 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. Parents are asked to play with their child for 15 minutes 3-4 times per week for 8 weeks. |
| Treatment as Usual | No intervention | –Participants in control group will continue their Applied Behavior Analysis therapy as usual for 8 weeks, and then will be able to cross-over to the treatment condition at week 8. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- A professional diagnosis of Autism that is able to be confirmed by negative score on a machine learning based algorithm using items from Mobile Autism Risk Assessment and video based classifier or by a copy of diagnostic report.
Key exclusion criteria (3 listed)
- Parent is unable to read the app in the offered languages (English, Spanish, Portuguese)
- Parent does not have an Android or iOS smartphone compatible with GuessWhat App.
- Child has additional psychiatric or neurologic diagnoses including genetic syndromes or epilepsy in addition to autism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Charades based mobile digital therapeuticAlso: GuessWhatThe mobile 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. Parents are asked to play with their child 15 minutes 3-4 times per week for 8 weeks. | Device | Charades-based mobile digital therapeutic |
Primary outcome
Change in parent reported socialization based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, from baseline to week 8
Time frame: Baseline (Week 0), Week 8
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 Intellectual Quotient-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.
2 secondary outcomes
Change in Parental Stress Scale - from baseline to week 8
Time frame: Baseline (Week 0), Week 8
Change in Emotion Recognition from baseline to week 8
Time frame: Baseline (Week 0), Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis P Wall, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charades based mobile digital therapeutic in people with Autism and Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaiti Dunlap, MRes (650-497-9214, kdunlap2@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent reported socialization based on the Vineland Adaptive Behavior Scales 3rd Edition (VABS-3) Parent/Caregiver Socialization Subscale, from baseline to week 8 (time frame: Baseline (Week 0), Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.