CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"

Recruiting

• Conditions: Suicide; Suicide, Attempted; Suicidal Ideation; Depression; Suicidal; Anxiety; Aggression; Trauma, Psychological
• Interventions: Behavioral: MHSAFE app recording

• Registration Number: NCT04493736
• Lead Sponsor: Clarigent Health

Brief Summary

Open enrollment study to collect data for the optimization of machine learning models for use in an app for the early detection of mental health and suicidal risk.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Currently a client receiving services from a MHP at a school or outpatient setting, or at a college/university counseling center
• Age ≥ 8 years old
• 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.
• Any adult participant for whom Legal Authorized Representative (LAR) 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 and / or neurocognitive disability that the MHP deems a barrier to participation
• Any participant, who at the discretion of the MHP, should not be enrolled

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	MHSAFE app recording	Any person receiving services from a mental health provider who is able to either consent or for whom parental consent is able to be obtained.

Primary Outcome Measures

Name	Time	Method
Detection of Mental Health State	1 year	Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.

Secondary Outcome Measures

Name	Time	Method
Demonstrate the Usability of the platform	1 year	Demonstrate the usability of the MHSAFE recording platform and the dashboard output in different settings, including outpatient community mental health settings, schools (K-12), colleges/universities, and residential mental health facilities.

Trial Locations

Locations (1)

Clarigent Health; 🇺🇸 Mason, Ohio, United States