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Classification and Assessment of Mental Health Performance Using Schematics (CAMPUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04275908
Recruitment Status : Active, not recruiting
First Posted : February 19, 2020
Last Update Posted : August 4, 2022
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Information provided by (Responsible Party):
Clarigent Health

Brief Summary:
This is an open enrollment study to collect data for the optimization of smartphone-based algorithms for the early detection of mental health and suicidal risk in a student population. Approximately 2000 students, ages 8-23, will be recruited by therapists across 30 schools and mental health centers.

Condition or disease Intervention/treatment
Suicide Ideation Suicidal Intention Suicide and Depression Device: MHSAFE app

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classification and Assessment of Mental Health Performance Using Schematics
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: MHSAFE app
    App to detect presence of mental state

Primary Outcome Measures :
  1. Algorithm development [ Time Frame: 3 years ]
    Participants will be asked about their mental health using standardized questionnaires and a specific set of additional questions developed to encourage an open conversation with the therapist. The app will record the therapy session and a proprietary algorithm will be tested to determine if it can accurately detect the presence of a mental state (for example, suicidal intention) as compared with the standardized questionnaires (e.g. Columbia scale) and the therapists' clinical impression.

  2. App optimization [ Time Frame: 3 years ]
    Convenient and accessible use of the app in a variety of settings where adolescents and young adults may require intervention for mental health and suicide-related concerns. Upon completion of the therapy sessions, the therapists will be asked to complete a questionnaire to provide feedback on the usability of the device in a real-world setting. This information will drive modifications to the app and to the device that it is used with (e.g. smartphone, tablet) to create second generation models that are user-friendly and provide valuable information in clinical settings.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Thirty sites across Southwest Ohio will be recruited, including schools (using the school-based therapists), community mental health centers, and colleges/universities (counseling centers). Approximately 150 therapists across 30 sites will be recruited to enroll students from their current caseloads.

Inclusion Criteria:

  • Currently a client receiving services from mental health agency at a school or outpatient, or at a college/university counseling center
  • Age ≥ 8 years and < 23years
  • 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.
  • 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 disability that the therapist deems a barrier to participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275908

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United States, Ohio
Clarigent Health
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Clarigent Health
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
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Study Director: Lesley Rohlfs Clarigent Health
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Responsible Party: Clarigent Health
ClinicalTrials.gov Identifier: NCT04275908    
Other Study ID Numbers: 102-2019
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms
Self-Injurious Behavior