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

• Sponsor: Clarigent Health (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04493736
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 51.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide; Suicidal; Suicide, Attempted; Suicidal Ideation; Depression; Anxiety; Aggression; Trauma, Psychological	Behavioral: MHSAFE app recording

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Case 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.	Behavioral: MHSAFE app recording; Participants are asked a series of questions to elicit their feelings and emotions as part of an audio recorded interview along with their normal therapy session.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 75 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clarigent Health	Mason	Ohio	United States	45040

Sponsors and Collaborators

• Clarigent Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clarigent Health
• ClinicalTrials.gov Identifier: NCT04493736
• Other Study ID Numbers: Clarigent 104-2020
• First Posted: Jul 30, 2020
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicide; Suicidal Ideation; Aggression; Suicide, Attempted; Psychological Trauma

Study Results

No Results Posted as of Aug 4, 2022