CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded" (CAMPUS-E)

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.

Study Overview

• Status: Recruiting
• Conditions: Aggression; Depression; Anxiety; Suicidal Ideation; Suicide, Attempted; Suicide; Trauma, Psychological; Suicidal
• Intervention / Treatment: Behavioral: MHSAFE app recording

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Mason, Ohio, United States, 45040
      • Recruiting
      • Clarigent Health
      • Contact: Clarigent Research; Phone Number: 513-445-3022; Email: research@clarigenthealth.com
      • Contact: Joshua I Cohen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Clarigent Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Stress Disorders, Traumatic; Aggression; Suicide; Suicidal Ideation; Suicide, Attempted; Psychological Trauma
• Other Study ID Numbers: Clarigent 104-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No