Recruiting

Observational Study

Sponsor:

Clarigent Health

Code:

NCT04493736

Conditions

Suicide

Suicidal

Suicide, Attempted

Suicidal Ideation

Depression

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

Interventions

MHSAFE app recording

Study Details

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.

Conditions

Suicide

Suicidal

Suicide, Attempted

Suicidal Ideation

Depression

Study ID

NCT04493736

Start date

Jun 1, 2020

Status verified date

Feb, 2024

Completion date

Sep 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Detection of Mental Health State [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Clarigent Health

Recruiting

Mason, Ohio, United States, 45040

Contacts

Clarigent Research

513-445-3022research@clarigenthealth.com

More Information

Sponsor

Clarigent Health

Last update posted

Feb 6, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Clarigent Health on 2024-02-06.