Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Cognoa ASD Digital Therapeutic Engagement and Usability Study

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Usability assessment of Cognoa ASD Therapeutic Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognoa ASD Therapeutic Device<br>Usability assessment of Cognoa ASD Therapeutic Device | Device: Usability assessment of Cognoa ASD Therapeutic Device<br>* Usability assessment of Cognoa ASD Therapeutic Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |