Autism Spectrum DisorderNCT04450641
Piloting a Mobile Game for Behavioral Therapy
A study testing GuessWhat Mobile Application in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial summary
The following study aims to understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the… Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- GuessWhat Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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.
Who cannot join
- Parent is not able to read or speak English
- Parent does not have an Android or iOs smartphone compatible with GuessWhat App
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Gamified Mobile Platform for Improving Social Communication in Children With Autism
The following study aims to understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game 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. The app will walk participants through a variety of charades style games. The interactive games will be video recorded and all data are transferred securely to the Wall Lab for analysis. This study is enrolling parents of children with ASD who are at least 18 years of age and have a child between 3-12 years old. Parents are asked to complete questionnaires before and after playing the GuessWhat game with their child 3-4 times per week for 4 weeks.
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- GuessWhat Mobile Application
- Keywords
- digital, mobile health, game, autism, technology, therapy
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuessWhat Mobile ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment group used GuessWhat during the 4 week intervention period. Receives: Other: GuessWhat Mobile Application |
| Control | Other | Participants in control group received standard treatment as usual. Receives: Other: GuessWhat Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent reported social responsiveness from week 0 to week 4
The Social Responsiveness Scale-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Measured: Baseline (Week 0), Week 4
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) 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 32 items, 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.
Measured: Baseline (Week 0), Week 4
Secondary outcomes (3)
GuessWhat App Usage Data
App usage data comprised of game decks selected, number of game sessions started, ended, and shared.
Measured: 4 weeks
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.
Measured: Week 4
Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Communication subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the communication domain of the VABS-III reflects The communication subscale is 32 items, 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.
Measured: Baseline (Week 0), Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Oct 2019
- Primary completion1 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
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
- NCT04450641
- Sponsor's protocol ID
- 39562
- Status last verified
- Feb 2021
- First submitted
- 24 Jun 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gamified Mobile Platform for Improving Social Communication in Children With Autism
- ClinicalTrials.gov ID
- NCT04450641
- Acronym / sponsor ID
- 39562
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- digital, mobile health, game, autism, technology, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jun 2020 (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 understand the feasibility of the mobile app and game, GuessWhat, to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style game 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. The app will walk participants through a variety of charades style games. The interactive games will be video recorded and all data are transferred securely to the Wall Lab for analysis. This study is enrolling parents of children with ASD who are at least 18 years of age and have a child between 3-12 years old. Parents are asked to complete questionnaires before and after playing the GuessWhat game with their child 3-4 times per week for 4 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: GuessWhat Mobile ApplicationTreatment group used GuessWhat during the 4 week intervention period. |
| Control | Other | Other: GuessWhat Mobile ApplicationParticipants in control group received standard treatment as usual. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 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.
Key exclusion criteria (2 listed)
- Parent is not able to read or speak English
- Parent does not have an Android or iOs smartphone compatible with GuessWhat App
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 |
|---|---|---|
| GuessWhat Mobile ApplicationThe 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. | Other | Control, Treatment |
Primary outcome
Change in parent reported social responsiveness from week 0 to week 4
Time frame: Baseline (Week 0), Week 4
The Social Responsiveness Scale-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Time frame: Baseline (Week 0), Week 4
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) 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 32 items, 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.
3 secondary outcomes
GuessWhat App Usage Data
Time frame: 4 weeks
Parent reported feedback
Time frame: Week 4
Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
Time frame: Baseline (Week 0), Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 GuessWhat Mobile Application in people with Autism Spectrum Disorder and Autism, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 3 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent reported social responsiveness from week 0 to week 4 (time frame: Baseline (Week 0), Week 4). The study lists 2 primary outcomes in all. 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 3 Feb 2021.