Clinical trial NCT04326231: Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
Official title: Cognoa ASD Digital Therapeutic Engagement and Usability Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Cognoa, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Vineland Adaptive Behavior Scales, Third Edition
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Cognoa
state: California
Study officials:
affiliation: Cognoa, Inc.
name: Kelley Abrams, PhD
role: PRINCIPAL_INVESTIGATOR
References: