CClinicalTrials.gg
RecruitingNCT04493736CAMPUS-EUpdated Feb 6, 2024

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

An observational study in Suicide, Suicidal and Suicide, Attempted, sponsored by Clarigent Health. Recruiting at 1 site in United States. Open to participants aged 8 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Clarigent Health · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2020; still recruiting 6 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,000
Ages
8 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Suicide
  • Suicidal
  • Suicide, Attempted
  • Suicidal Ideation
  • Depression
  • Anxiety
  • Aggression
  • Trauma, Psychological
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 159 across 122 observational studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Clarigent Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 75 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • BehavioralMHSAFE 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.

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Clarigent Health
    Mason, Ohio 45040, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04493736
Lead sponsor
Clarigent Health
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Jun 1, 2020
Primary completion
Sep 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Feb 6, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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