Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting

Completed

Conditions studied: Children18-72 Months With a Suspicion Autistic Disorder

In brief

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 clinical data for eligible participants. All decisions regarding patient care will be determined by the ECHO Autism Clinician (EAC). All clinical outcomes will be assessed by the EAC as would occur in routine clinical practice.

Key facts

Study ID

NCT05223374

Run by

Cognoa, Inc.

People needed

110

Starts

2022-03-01

Expected to finish

2024-02-04

Last updated by the study team

2024-02-08

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ECHO Autism — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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