Status:
COMPLETED
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
Lead Sponsor:
Cognoa, Inc.
Collaborating Sponsors:
University of Missouri-Columbia
Conditions:
Children18-72 Months With a Suspicion Autistic Disorder
Eligibility:
All Genders
18-72 years
Brief Summary
This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD. The study will contain demographic and observational...
Detailed Description
The study will be conducted by the University of Missouri ECHO Autism Communities Research Team (RT). Research participants recruited by the RT will include: 1) University of Missouri ECHO Autism Comm...
Eligibility Criteria
Inclusion
- English is spoken proficiently by the participating patient/family, in the opinion of the EAC.
- Meets labeling of device
- Parent, guardian, or legally authorized representative (LAR) must be able to read, understand, and sign and date the Informed Consent Form (ICF)
- Sex assigned at birth (Female or male or non-binary)
- Female or male, \> 18 to \< 72 months of age
- Caregiver, HCP or community-based professional concern for developmental delay or Autism
- Parent/guardian/LAR must have smartphone utilizing the most recent and previous version of iOS and Android operating systems (iOS 13 or 14; Android 10 or 11, excluding Android Go)
- Participants must be willing to be videotaped as part of the device input
Exclusion
- Participants with a prior diagnosis of Autism Spectrum Disorder (ASD) rendered by a healthcare professional
- Participants with any other medical, behavioral, or developmental condition that in the opinion of the ECHO Autism Clinician may confound study data/assessments
- Participants whose age on the date of enrollment is outside the target age range
- Participants or caregivers who have, to the best of their knowledge, been previously enrolled in any Cognoa clinical study or survey
Key Trial Info
Start Date :
March 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05223374
Start Date
March 1 2022
End Date
February 4 2024
Last Update
February 8 2024
Active Locations (1)
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1
ECHO Autism
Columbia, Missouri, United States, 65201