Children18-72 Months With a Suspicion Autistic DisorderNCT05223374
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
An observational study of Children18-72 Months With a Suspicion Autistic Disorder, run by Cognoa, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Children18-72 Months With a Suspicion Autistic Disorder
- What is being tested?
- Canvas Dx
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 4 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 18-72 months who have a suspicion of ASD.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Canvas Dx
- Keywords
- Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canvas DxDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Canvas Dx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Mar 2022
- Primary completion4 Feb 2024
- Study completion4 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Children18-72 Months With a Suspicion Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognoa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Kristin Sohl, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223374
- Sponsor's protocol ID
- 2075722
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Clinical Study Report (CSR) findings will be shared once analyzed.
Publications
Sohl K, Linstead E, Heinz K, Lledo EE, Brewer Curran A, Mahurin M, Nanclares-Nogues V, Salomon C, Seal M, Taraman S. Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study. JMIR Form Res. 2025 Oct 21;9:e80733. doi: 10.2196/80733.
PubMed 41124399Sohl 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.
PubMed 35852831
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
- ClinicalTrials.gov ID
- NCT05223374
- Acronym / sponsor ID
- 2075722
- Keywords
- Autism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cognoa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 4 Feb 2024 (actual)
- Study completion
- 4 Feb 2024 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx | – | Device: Canvas DxTime from initial concern to diagnosis when using Canvas Dx as part of the diagnostic process (Reported time to diagnosis) |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 18-72 months who have a suspicion of ASD.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canvas DxCanvas 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) | Device | Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx |
Primary outcome
Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx
Time frame: up to 2 months
Assessing the time frame to diagnosis from the initial concern by the EAC utilizing Canvas Dx
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 41124399Sohl K, Linstead E, Heinz K, Lledo EE, Brewer Curran A, Mahurin M, Nanclares-Nogues V, Salomon C, Seal M, Taraman S. Integration of an Artificial Intelligence-Based Autism Diagnostic Device into the ECHO Autism Primary Care Workflow: Prospective Observational Study. JMIR Form Res. 2025 Oct 21;9:e80733. doi: 10.2196/80733.
- Derived from this study: PubMed 35852831Sohl 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.
- Individual participant dataSharing planned: Undecided. The Clinical Study Report (CSR) findings will be shared once analyzed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Sohl, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children18-72 Months With a Suspicion Autistic Disorder, run by Cognoa, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the time to diagnosis from initial concern by EAC utilizing Canvas Dx (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.