An observational study in Children18-72 Months With a Suspicion Autistic Disorder, sponsored by Cognoa, Inc.. Completed at 1 site in United States. Open to participants aged 18 Months to 72 Months. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Cognoa, Inc. · Observational
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:
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 110 is close to the median of 102 across 267 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Cognoa, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 18-72 months who have a suspicion of ASD.
Exclusion Criteria:
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)
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
Time frame: up to 2 months
Plan to share: Undecided — The Clinical Study Report (CSR) findings will be shared once analyzed.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Cognoa, Inc.