Classification and Assessment of Mental Health Performance Using Schematics

Completed

• Conditions: Suicide Ideation; Suicide and Depression; Suicidal Intention

• Registration Number: NCT04275908
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
App optimization	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.
Algorithm development	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.

Trial Locations

Locations (1)

Clarigent Health; 🇺🇸 Mason, Ohio, United States