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

NCT04493736 | Recruiting

• 1 other identifier: Clarigent 104-2020
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demonstrate the Usability of the platform

  1 year

Study Arms (1)

Case

Any person receiving services from a mental health provider who is able to either consent or for whom parental consent is able to be obtained.

Behavioral: MHSAFE app recording

Interventions

MHSAFE app recording BEHAVIORAL

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.

Case

Eligibility Criteria

• Age: 8 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study employs a cohort design, using open and rolling recruitment of MHP participants at multiple locationssites nationally. We will recruit from mental health therapy practices, schools (using school based MHPs), community mental health agencies, or colleges/universities (counseling centers). Participating MHPs will begin enrolling client participants after completing the online protocol training and brief human subject's protection training. Recruitment will continue on a rolling basis until 2000 client participants have been enrolled and 6000 sessions have been recorded.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clarigent Health: lead

Study Sites (1)

Clarigent Health

Mason, Ohio, 45040, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Audio recorded voice samples

MeSH Terms

Conditions

Suicide; Suicide, Attempted; Suicidal Ideation; Depression; Anxiety Disorders; Aggression; Psychological Trauma

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders; Aberrant Motor Behavior in Dementia; Social Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 30, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)