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

Completed

• Conditions: Children18-72 Months With a Suspicion Autistic Disorder
• Interventions: Device: Canvas Dx

• Registration Number: NCT05223374
• Lead Sponsor: Cognoa, Inc.

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

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-04
• Study Start: 2022-03-01
• Primary Completion: 2024-02-04
• Study Completion: 2024-02-04
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx	Canvas Dx	Time from initial concern to diagnosis when using Canvas Dx as part of the diagnostic process (Reported time to diagnosis)

Primary Outcome Measures

Name	Time	Method
Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx	up to 2 months	Assessing the time frame to diagnosis from the initial concern by the EAC utilizing Canvas Dx

Trial Locations

Locations (1)

ECHO Autism; 🇺🇸 Columbia, Missouri, United States