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

NCT ID: NCT05223374

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-02-04

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.

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 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

Conditions

Children18-72 Months With a Suspicion Autistic Disorder

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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)

Canvas Dx

Intervention Type: 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)

Interventions

Canvas Dx

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. English is spoken proficiently by the participating patient/family, in the opinion of the EAC.

2. Meets labeling of device

3. Parent, guardian, or legally authorized representative (LAR) must be able to read, understand, and sign and date the Informed Consent Form (ICF)

4. Sex assigned at birth (Female or male or non-binary)

5. Female or male, > 18 to < 72 months of age

6. Caregiver, HCP or community-based professional concern for developmental delay or Autism

7. 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)

8. Participants must be willing to be videotaped as part of the device input

Exclusion Criteria

1. Participants with a prior diagnosis of Autism Spectrum Disorder (ASD) rendered by a healthcare professional

2. Participants with any other medical, behavioral, or developmental condition that in the opinion of the ECHO Autism Clinician may confound study data/assessments

3. Participants whose age on the date of enrollment is outside the target age range

4. Participants or caregivers who have, to the best of their knowledge, been previously enrolled in any Cognoa clinical study or survey

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: collaborator

Cognoa, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Sohl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

ECHO Autism

Columbia, Missouri, United States

Countries

United States

References

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 into the ECHO Autism Primary Care Early Diagnostic workflow: results of a prospective observational study. JMIR Form Res. 2025 Sep 30. doi: 10.2196/80733. Online ahead of print.

Reference Type: DERIVED

PMID: 41026478 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35852831 (View on PubMed)

Other Identifiers

2075722

Identifier Type: -

Identifier Source: org_study_id