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

February 5, 2024 updated by: Clarigent Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Mason, Ohio, United States, 45040
        • Clarigent Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 23 years (Child, Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clarigent Health

Collaborators

Children's Hospital Medical Center, Cincinnati
University of Cincinnati

Investigators

  • Study Director: Lesley Rohlfs, Clarigent Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Estimated)

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

Other Study ID Numbers

  • 102-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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