Autism Spectrum DisorderNCT04909710
Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
A study testing Mobile Game System for Potential Treatment of Developmental Delays in people with Autism Spectrum Disorder and Autism, run by Stanford University at 1 site in United States.
Trial summary
The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism
- What is being tested?
- Mobile Game System for Potential Treatment of Developmental Delays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 28 Feb 2026
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old.
- Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.
Who cannot join
- Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).
- Conditions
- Autism Spectrum Disorder, Autism
- Being tested
- Mobile Game System for Potential Treatment of Developmental Delays
- Keywords
- digital, mobile, autism
- 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.
Mobile Game System for Potential Treatment of Developmental DelaysOther
Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism.
| Study group | Role | What they receive |
|---|---|---|
| Autism Case Group | Experimental | Autistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion. Receives: Other: Mobile Game System for Potential Treatment of Developmental Delays |
| Neurotypical Sibling Control Group | Other | Neurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion. Receives: Other: Mobile Game System for Potential Treatment of Developmental Delays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver
The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (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 12
Mobile Application Usage-Total games started.
App usage data by participants (children) comprised of total number of MojiMatch plus Charades Games started.
Measured: Week 12
Secondary outcomes (2)
Change in parent reported social responsiveness from week 0 to week 12
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 severity Social 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 12
Change in mobile autism risk assessment score from week 0 to week 12
A level 2 screening tool that has been validated in several studies and that uses a brief parent questionnaire with a 2 minute home video to generate a classification score that indicates severity of the autism phenotype (ranging from no autistic symptoms to severe autism) as well as confidence in the classification.
Measured: Baseline (Week 0), Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start15 Jul 2021 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Why it stopped: we are suspending this study until we have continued funding.
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
- The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.
- Masking
- None (open label)
- Enrolment
- 0 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, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909710
- Sponsor's protocol ID
- IRB 39562
- Status last verified
- Sep 2024
- First submitted
- 13 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
- ClinicalTrials.gov ID
- NCT04909710
- Acronym / sponsor ID
- IRB 39562
- Conditions
- Autism Spectrum Disorder, Autism
- Keywords
- digital, mobile, autism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we are suspending this study until we have continued funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 2 Jun 2021 (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 investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.
| Arm | Type | Receives |
|---|---|---|
| Autism Case Group | Experimental | Other: Mobile Game System for Potential Treatment of Developmental DelaysAutistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion. |
| Neurotypical Sibling Control Group | Other | Other: Mobile Game System for Potential Treatment of Developmental DelaysNeurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parent or primary caregiver over 18 of a child with autism, we will enrich for children between the ages of 2 and 8 years old.
- Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.
Key exclusion criteria (1 listed)
- Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
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 |
|---|---|---|
| Mobile Game System for Potential Treatment of Developmental DelaysMobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. | Other | Autism Case Group, Neurotypical Sibling Control Group |
Primary outcome
Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver
Time frame: Baseline (Week 0), Week 12
The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (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.
Mobile Application Usage-Total games started.
Time frame: Week 12
App usage data by participants (children) comprised of total number of MojiMatch plus Charades Games started.
2 secondary outcomes
Change in parent reported social responsiveness from week 0 to week 12
Time frame: Baseline (Week 0), Week 12
Change in mobile autism risk assessment score from week 0 to week 12
Time frame: Baseline (Week 0), Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Dennis P Wall, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Game System for Potential Treatment of Developmental Delays 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 1 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 was withdrawn before enrolling participants, so there are no results.
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 socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12 Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver (time frame: Baseline (Week 0), Week 12). 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 19 Sep 2024.