Clinical trial NCT05223374: Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
Official title: Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children18-72 Months With a Suspicion Autistic Disorder
Keywords: Autism
Lead sponsor: Cognoa, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Missouri-Columbia
First posted: 2022-02-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 18-72 months who have a suspicion of ASD.

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

Eligibility criteria: 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

Primary outcomes:
measure: Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: ECHO Autism
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Kristin Sohl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.