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

Primary Purpose

Autism Spectrum Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Usability assessment of Cognoa ASD Therapeutic Device

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cognoa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognoa ASD Therapeutic Device

Arm Description

Usability assessment of Cognoa ASD Therapeutic Device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04326231

First Posted

March 23, 2020

Last Updated

August 28, 2023

Sponsor

Cognoa, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04326231

Brief Title

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

Official Title

Cognoa ASD Digital Therapeutic Engagement and Usability Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

COVID and the Study was withdrawn (limited recruitment within study timeline)

Study Start Date

March 17, 2020 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cognoa, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognoa ASD Therapeutic Device

Arm Type

Experimental

Arm Description

Usability assessment of Cognoa ASD Therapeutic Device

Intervention Type

Device

Intervention Name(s)

Usability assessment of Cognoa ASD Therapeutic Device

Intervention Description

Usability assessment of Cognoa ASD Therapeutic Device

Primary Outcome Measure Information:

Title

Vineland Adaptive Behavior Scales, Third Edition

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelley Abrams, PhD

Organizational Affiliation

Cognoa, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cognoa

City

Palo Alto

State/Province

California

ZIP/Postal Code

94306

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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