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

NCT05223374 | Completed

• 1 other identifier: 2075722
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Children18-72 Months With a Suspicion Autistic Disorder

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

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

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

  up to 2 months

Study Arms (1)

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

Time from initial concern to diagnosis when using Canvas Dx as part of the diagnostic process (Reported time to diagnosis)

Device: Canvas Dx

Interventions

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)

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

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 18-72 months who have a suspicion of ASD.

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

Sponsors & Collaborators

• Cognoa, Inc.: lead
• University of Missouri-Columbia: collaborator

Study Sites (1)

ECHO Autism

Columbia, Missouri, 65201, United States

Location

Related Publications (2)

• Sohl K, Linstead E, Heinz K, Lledo EE, Brewer Curran A, Mahurin M, Nanclares-Nogues V, Salomon C, Seal M, Taraman S. Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study. JMIR Form Res. 2025 Oct 21;9:e80733. doi: 10.2196/80733.

  PMID: 41124399 DERIVED

• Sohl K, Kilian R, Brewer Curran A, Mahurin M, Nanclares-Nogues V, Liu-Mayo S, Salomon C, Shannon J, Taraman S. Feasibility and Impact of Integrating an Artificial Intelligence-Based Diagnosis Aid for Autism Into the Extension for Community Health Outcomes Autism Primary Care Model: Protocol for a Prospective Observational Study. JMIR Res Protoc. 2022 Jul 19;11(7):e37576. doi: 10.2196/37576.

  PMID: 35852831 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kristin Sohl, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 4, 2022
• Study Start: March 1, 2022
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: February 8, 2024

Record last verified: 2022-01

Locations

US (1)