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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children aged 18-72 months who have a suspicion of ASD.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Sohl, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ECHO Autism | Columbia | Missouri | 65201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41124399 | Derived | 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. | |
| 35852831 |
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The Clinical Study Report (CSR) findings will be shared once analyzed.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. |