Suicide IdeationCAMPUSNCT04275908
Classification and Assessment of Mental Health Performance Using Schematics
An observational study of Suicide Ideation and Suicidal Intention, run by Clarigent Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Ideation, Suicidal Intention, Suicide and Depression
- What is being tested?
- MHSAFE app
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jan 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- MHSAFE app
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHSAFE appDevice
App to detect presence of mental state
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarigent Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Medical Center, Cincinnati, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Lesley Rohlfs, Study director, Clarigent Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275908
- Sponsor's protocol ID
- 102-2019
- Acronym
- CAMPUS
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No