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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Children 18-72 Months With a Suspicion of Autism Spectrum Disorder

Intervention / Treatment
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* Device: Canvas Dx


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx<br>Time from initial concern to diagnosis when using Canvas Dx as part of the diagnostic process (Reported time to diagnosis) | Device: Canvas Dx<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism