Classification and Assessment of Mental Health Performance Using Schematics

Suicide Ideation Clinical Trial

— CAMPUS  

Official title:

Classification and Assessment of Mental Health Performance Using Schematics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275908
• Other study ID #: 102-2019
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: February 2024
• Source: Clarigent Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 23 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Intention
• Suicide
• Suicide and Depression
• Suicide Ideation

Intervention

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

Locations

Country	Name	City	State
United States	Clarigent Health	Mason	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Clarigent Health	Children's Hospital Medical Center, Cincinnati, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm development	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
Primary	App optimization	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