CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"

Depression Clinical Trial

— CAMPUS-E  

Official title:

CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493736
• Other study ID #: Clarigent 104-2020
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Clarigent Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Open enrollment study to collect data for the optimization of machine learning models for use in an app for the early detection of mental health and suicidal risk.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 8 Years to 75 Years

Eligibility

Inclusion Criteria:

• Currently a client receiving services from a MHP at a school or outpatient setting, or at a college/university counseling center

• Age = 8 years old

• Able to provide informed consent, parental permission or assent

• English as a primary language

Exclusion Criteria:

• Participants with communication disorders (linguistic or articulation)

• Any minor participants for whom parental or legal guardian consent cannot be obtained.

• Any adult participant for whom Legal Authorized Representative (LAR) consent cannot be obtained.

• History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll them

• Participants with an intellectual and / or neurocognitive disability that the MHP deems a barrier to participation

• Any participant, who at the discretion of the MHP, should not be enrolled

Related Conditions & MeSH terms

• Aggression
• Anxiety
• Depression
• Psychological Trauma
• Suicidal
• Suicidal Ideation
• Suicide
• Suicide, Attempted
• Trauma, Psychological

Intervention

Behavioral:
• MHSAFE app recording
Participants are asked a series of questions to elicit their feelings and emotions as part of an audio recorded interview along with their normal therapy session.

Locations

Country	Name	City	State
United States	Clarigent Health	Mason	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Clarigent Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Mental Health State	Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.	1 year
Secondary	Demonstrate the Usability of the platform	Demonstrate the usability of the MHSAFE recording platform and the dashboard output in different settings, including outpatient community mental health settings, schools (K-12), colleges/universities, and residential mental health facilities.	1 year