Classification and Assessment of Mental Health Performance Using Schematics

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.

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Key information

Conditions

Suicide Ideation Behavior Behavioral Symptoms Depression Self-Injurious Behavior Suicidal Intention Suicide Suicide and Depression

Age range

8 year–23 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clarigent Health

Mason, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MHSAFE app

Device

App to detect presence of mental state

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Clarigent Health

Industry

Collaborators

Children's Hospital Medical Center, Cincinnati
University of Cincinnati

Registry information

Acronym: CAMPUS

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Feb 19, 2020
Registry last updated: Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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