SuicideCAMPUS-ENCT04493736
CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"
An observational study of Suicide and Suicidal, run by Clarigent Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Suicide, Suicidal, Suicide, Attempted
- What is being tested?
- MHSAFE app recording
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Child, Adult, Older adult
Study population: The study employs a cohort design, using open and rolling recruitment of MHP participants at multiple locationssites nationally. We will recruit from mental health therapy practices, schools (using school based MHPs), community mental health agencies, or colleges/universities (counseling centers). Participating MHPs will begin enrolling client participants after completing the online protocol training and brief human subject's protection training. Recruitment will continue on a rolling basis until 2000 client participants have been enrolled and 6000 sessions have been recorded.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Clarigent Health
Mason, Ohio, 45040
Clarigent Research, 513-445-3022, research@clarigenthealth.com
Joshua I Cohen, PhD
About this study
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, Anxiety
- Being tested
- MHSAFE app recording
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation, Depression, Anxiety Disorders, Aggression, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHSAFE app recordingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MHSAFE app recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Mental Health State
Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.
Measured: 1 year
Secondary outcomes (1)
Demonstrate the Usability of the platform
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarigent Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493736
- Sponsor's protocol ID
- Clarigent 104-2020
- Acronym
- CAMPUS-E
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2020
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMPUS Expanded "Classification and Assessment of Mental Health Performance Using Semantics Expanded"
- ClinicalTrials.gov ID
- NCT04493736
- Acronym / sponsor ID
- CAMPUS-E / Clarigent 104-2020
- Conditions
- Suicide, Suicidal, Suicide, Attempted, Suicidal Ideation, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Clarigent HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case | – | Behavioral: MHSAFE app recordingAny person receiving services from a mental health provider who is able to either consent or for whom parental consent is able to be obtained. |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study employs a cohort design, using open and rolling recruitment of MHP participants at multiple locationssites nationally. We will recruit from mental health therapy practices, schools (using school based MHPs), community mental health agencies, or colleges/universities (counseling centers). Participating MHPs will begin enrolling client participants after completing the online protocol training and brief human subject's protection training. Recruitment will continue on a rolling basis until 2000 client participants have been enrolled and 6000 sessions have been recorded.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHSAFE app recordingParticipants 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. | Behavioural | Case |
Primary outcome
Detection of Mental Health State
Time frame: 1 year
Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.
1 secondary outcome
Demonstrate the Usability of the platform
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Suicidal, run by Clarigent Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Mental Health State (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.