Autism Spectrum DisorderNCT04326231
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
A study testing Usability assessment of Cognoa ASD Therapeutic Device in people with Autism Spectrum Disorder, run by Cognoa, Inc. at 1 site in United States.
Trial summary
Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Usability assessment of Cognoa ASD Therapeutic Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Functional English language capability in the home environment.
- Parent, Guardian, or legal authorized representative (LAR) must be able to read, understand and sign the Informed Consent Form (ICF)
- Female or Male, > 3 to < 9 years of age and parent/caregiver
- Diagnosis of Autism Spectrum Disorder, within the last 12 months
- Parent, Guardian, or legal authorized representative (LAR) must have smartphone capabilities for downloading Testflight software; test versions of the Cognoa for Child development app; and test versions of the Cognoa Digital Therapeutic app (iOS 12.0 and up and Apple iPhone 8 and higher)
Who cannot join
- Participants with any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments.
- Participants with planned extensive travel (more than 1 week) during the course of the 4 week intervention time period.
- Participants with deafness or blindness.
- Participants with known physical impairments affecting their ability to use their hands.
- Participants with active diagnosis of epilepsy and uncontrolled seizures.
- Participants whose age on the date of enrollment is outside the target age range
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognoa ASD Digital Therapeutic Engagement and Usability Study
Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device.
Read the detailed description
Parents who consent will be given access to the study device through its caregiver and child-facing smartphone app that provides therapeutic content. In order to access the study device app, parents will be provided access to two other apps. The first is Testflight. TestFlight is an online service for over-the-air installation and testing of mobile applications, currently owned by Apple Inc.that allows users to test iOS apps before they are released to the App Store. Parents will also be provided access to the Cognoa for Child Development app in order to create an account as a means to gain access to the study device app. The parents will only be able to engage with the study device app once they have created an account in the Cognoa for Child for Development app
- Conditions
- Autism Spectrum Disorder
- Being tested
- Usability assessment of Cognoa ASD Therapeutic Device
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability assessment of Cognoa ASD Therapeutic DeviceDevice
Usability assessment of Cognoa ASD Therapeutic Device
| Study group | Role | What they receive |
|---|---|---|
| Cognoa ASD Therapeutic Device | Experimental | Usability assessment of Cognoa ASD Therapeutic Device Receives: Device: Usability assessment of Cognoa ASD Therapeutic Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vineland Adaptive Behavior Scales, Third Edition
Change was calculated on an average from all relevant time points used in the calculation in the Time Frame ( baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment); These measures were not completed due to COVID
Change in scores on the Vineland-3 domain level caregiver report social skills and relationships, measures of usability.
Qualitative descriptors: scores of 1 to 17 may be considered Average, 18 to 20 Elevated, and 21 to 24 Clinically Significant
Caregivers partially completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study.
0 Caregivers had their scores analyzed as they were unable to complete the study due to COVID, this study was terminated.
Measured: Enrollment, baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment; These measures were not completed due to COVID
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start17 Mar 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: COVID and the Study was withdrawn (limited recruitment within study timeline)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognoa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelley Abrams, PhD, Principal investigator, Cognoa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326231
- Sponsor's protocol ID
- PRO-003
- Status last verified
- Aug 2023
- First submitted
- 23 Mar 2020
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognoa ASD Digital Therapeutic Engagement and Usability Study
- ClinicalTrials.gov ID
- NCT04326231
- Acronym / sponsor ID
- PRO-003
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID and the Study was withdrawn (limited recruitment within study timeline)
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cognoa, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device.
Detailed description
Parents who consent will be given access to the study device through its caregiver and child-facing smartphone app that provides therapeutic content. In order to access the study device app, parents will be provided access to two other apps. The first is Testflight. TestFlight is an online service for over-the-air installation and testing of mobile applications, currently owned by Apple Inc.that allows users to test iOS apps before they are released to the App Store. Parents will also be provided access to the Cognoa for Child Development app in order to create an account as a means to gain access to the study device app. The parents will only be able to engage with the study device app once they have created an account in the Cognoa for Child for Development app
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognoa ASD Therapeutic Device | Experimental | Device: Usability assessment of Cognoa ASD Therapeutic DeviceUsability assessment of Cognoa ASD Therapeutic Device |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Functional English language capability in the home environment.
- Parent, Guardian, or legal authorized representative (LAR) must be able to read, understand and sign the Informed Consent Form (ICF)
- Female or Male, > 3 to < 9 years of age and parent/caregiver
- Diagnosis of Autism Spectrum Disorder, within the last 12 months
- Parent, Guardian, or legal authorized representative (LAR) must have smartphone capabilities for downloading Testflight software; test versions of the Cognoa for Child development app; and test versions of the Cognoa Digital Therapeutic app (iOS 12.0 and up and Apple iPhone 8 and higher)
Key exclusion criteria (6 listed)
- Participants with any other medical, behavioral, or developmental condition that in the opinion of the investigator may confound study data/assessments.
- Participants with planned extensive travel (more than 1 week) during the course of the 4 week intervention time period.
- Participants with deafness or blindness.
- Participants with known physical impairments affecting their ability to use their hands.
- Participants with active diagnosis of epilepsy and uncontrolled seizures.
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 |
|---|---|---|
| Usability assessment of Cognoa ASD Therapeutic DeviceUsability assessment of Cognoa ASD Therapeutic Device | Device | Cognoa ASD Therapeutic Device |
Primary outcome
Vineland Adaptive Behavior Scales, Third Edition
Time frame: Enrollment, baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment; These measures were not completed due to COVID
Change was calculated on an average from all relevant time points used in the calculation in the Time Frame ( baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment); These measures were not completed due to COVID Change in scores on the Vineland-3 domain level caregiver report social skills and relationships, measures of usability. Qualitative descriptors: scores of 1 to 17 may be considered Average, 18 to 20 Elevated, and 21 to 24 Clinically Significant Caregivers partially completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study. 0 Caregivers had their scores analyzed as they were unable to complete the study due to COVID, this study was terminated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kelley Abrams, PhD principal investigator
Cognoa, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usability assessment of Cognoa ASD Therapeutic Device in people with Autism Spectrum Disorder, run by Cognoa, Inc. 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vineland Adaptive Behavior Scales, Third Edition (time frame: Enrollment, baseline assessment, 4 weeks of intervention 4-6 times a week, weekly surveys of usability, final assessment; These measures were not completed due to COVID). 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 21 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.