Autism Spectrum Disorder
Conditions
Brief 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.
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
Interventions
DEVICEUsability assessment of Cognoa ASD Therapeutic Device
Usability assessment of Cognoa ASD Therapeutic Device
Sponsors
Cognoa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vineland Adaptive Behavior Scales, Third Edition | 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. |
Countries
United States
Participant flow
Recruitment details
Withdrawn (limited recruitment within study timeline)
Pre-assignment details
The protocol enrollment number represents Child/Caregiver enrollment in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID Withdrawn (limited recruitment within study timeline) | 10 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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
Population: 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.