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.

Study Overview

• Status: Completed
• Conditions: Children18-72 Months With a Suspicion Autistic Disorder
• Intervention / Treatment: Device: Canvas Dx

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

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

• Study Contact: Name: Kristin Sohl, MD; Phone Number: 573-882-2578; Email: SohlK@health.missouri.edu
• Study Contact Backup: Name: Alicia L Curran, BS; Phone Number: 573-882-2578; Email: CurranA@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • ECHO Autism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cognoa, Inc.
• Collaborators: University of Missouri-Columbia
• Investigators: Principal Investigator: Kristin Sohl, MD, University of Missouri-Columbia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): February 4, 2024
• Study Completion (Actual): February 4, 2024

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Autism
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: 2075722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Clinical Study Report (CSR) findings will be shared once analyzed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No