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COVID and the Study was withdrawn (limited recruitment within study timeline)
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognoa ASD Therapeutic Device | Experimental | Usability assessment of Cognoa ASD Therapeutic Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usability assessment of Cognoa ASD Therapeutic Device | Device | Usability assessment of Cognoa ASD Therapeutic Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelley Abrams, PhD | Cognoa, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognoa | Palo Alto | California | 94306 | United States |
The protocol enrollment number represents Child/Caregiver enrollment in the study.
Withdrawn (limited recruitment within study timeline)
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognoa ASD Therapeutic Device | Usability assessment of Cognoa ASD Therapeutic Device Usability assessment of Cognoa ASD Therapeutic Device: Usability assessment of Cognoa ASD Therapeutic Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Up to 30 caregivers and children diagnosed with ASD ages > 3 to < 9 years of age will be recruited from across the U.S.
Baseline data was only collected for children. This study was terminated data was not collected.
Zero participants completed the study due to COVID.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognoa ASD Therapeutic Device | Usability assessment of Cognoa ASD Therapeutic Device Usability assessment of Cognoa ASD Therapeutic Device: Usability assessment of Cognoa ASD Therapeutic Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Study was terminated and data was not collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 0 Caregivers completed their scores on the Vineland Adaptive Behavior Scales, Third Edition, This was due to COVID and not being able to complete the study. This study was terminated. Data were not collected due to early termination of the study. | Posted | 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 |
This study was terminated. no adverse events were not collected due to early termination of the study.
This study was terminated. no adverse events were not collected due to early termination of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary | Usability of Cognoa ASD Therapeutic Device Zero subjects completed the study due to COVID. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Research | Cognoa | 4082076659 | minda.seal@cognoa.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2020 | Oct 22, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| No |
|
| Sex: Female, Male | Study was terminated and data was not collected. |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | Study was terminated and data was not collected. | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Caregivers | Caregivers and female and male participants between the ages >3 years and < 9 years of age on date of enrollment from a general population diagnosed with ASD |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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