Classification and Assessment of Mental Health Performance Using Schematics

NCT04275908 | Completed

• 1 other identifier: 102-2019
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide Ideation; Suicidal Intention; Suicide and Depression

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

MHSAFE app DEVICE

App to detect presence of mental state

Eligibility Criteria

• Age: 8 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Thirty sites across Southwest Ohio will be recruited, including schools (using the school-based therapists), community mental health centers, and colleges/universities (counseling centers). Approximately 150 therapists across 30 sites will be recruited to enroll students from their current caseloads.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clarigent Health: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

Clarigent Health

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Suicide; Depression

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Lesley Rohlfs

  Clarigent Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 19, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)