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

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.

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Key information

Conditions

Children18-72 Months With a Suspicion Autistic Disorder Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 month–72 month

Sex eligibility

All sexes

Study type

Observational

Primary location

ECHO Autism

Columbia, Missouri, 65201, United States

About this study

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 Community trained clinicians (EACs) in both rural and suburban areas across the United States; 2)Caregivers/Patients with a suspicion of autism. Caregivers/Patients with a suspicion of autism and EACs will complete the informed consent process prior to entering the study. Once enrolled, EACs will provide routine clinical care and conduct best-practice ECHO Autism diagnostic evaluations with the addition of Canvas Dx to patients who have a suspicion of autism spectrum disorder. Canvas Dx will be prescribed; the caregiver will download and access the diagnostic app with a code. The caregiver will then complete the following activities:

Complete Caregiver Questionnaire in the mobile app
Upload two 90 sec to 5-minute videos of the participant through the mobile app

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Canvas Dx

Device

Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only (Rx only)

Primary outcomes

Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx

Time frame: up to 2 months

Assessing the time frame to diagnosis from the initial concern by the EAC utilizing Canvas Dx

Sponsors and collaborators

Lead sponsor

Cognoa, Inc.

Industry

Collaborators

University of Missouri-Columbia

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Feb 4, 2022
Registry last updated: Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed