NCT04326231

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

March 23, 2020

Results QC Date

October 27, 2021

Last Update Submit

August 28, 2023

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Cognoa ASD Therapeutic Device

EXPERIMENTAL

Usability assessment of Cognoa ASD Therapeutic Device

Device: Usability assessment of Cognoa ASD Therapeutic Device

Interventions

Usability assessment of Cognoa ASD Therapeutic DeviceDEVICE

Usability assessment of Cognoa ASD Therapeutic Device

Cognoa ASD Therapeutic Device

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cognoa

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Senior Director of Clinical Research
Organization
Cognoa
minda.seal@cognoa.com
4082076659

Study Officials

  • Kelley Abrams, PhD

    Cognoa, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 30, 2020

Study Start

March 17, 2020

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

September 21, 2023

Results First Posted

September 21, 2023

Record last verified: 2023-08

Locations

US(1)