<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493736</url>
  </required_header>
  <id_info>
    <org_study_id>Clarigent 104-2020</org_study_id>
    <nct_id>NCT04493736</nct_id>
  </id_info>
  <brief_title>CAMPUS Expanded &quot;Classification and Assessment of Mental Health Performance Using Semantics Expanded&quot;</brief_title>
  <acronym>CAMPUS-E</acronym>
  <official_title>CAMPUS Expanded &quot;Classification and Assessment of Mental Health Performance Using Semantics Expanded&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clarigent Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clarigent Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open enrollment study to collect data for the optimization of machine learning models for use&#xD;
      in an app for the early detection of mental health and suicidal risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of Mental Health State</measure>
    <time_frame>1 year</time_frame>
    <description>Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstrate the Usability of the platform</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Suicide</condition>
  <condition>Suicidal</condition>
  <condition>Suicide, Attempted</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Aggression</condition>
  <condition>Trauma, Psychological</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MHSAFE app recording</intervention_name>
    <description>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.</description>
    <arm_group_label>Case</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Audio recorded voice samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study employs a cohort design, using open and rolling recruitment of MHP participants&#xD;
        at multiple locationssites nationally. We will recruit from mental health therapy&#xD;
        practices, schools (using school based MHPs), community mental health agencies, or&#xD;
        colleges/universities (counseling centers). Participating MHPs will begin enrolling client&#xD;
        participants after completing the online protocol training and brief human subject's&#xD;
        protection training. Recruitment will continue on a rolling basis until 2000 client&#xD;
        participants have been enrolled and 6000 sessions have been recorded.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently a client receiving services from a MHP at a school or outpatient setting, or&#xD;
             at a college/university counseling center&#xD;
&#xD;
          -  Age ≥ 8 years old&#xD;
&#xD;
          -  Able to provide informed consent, parental permission or assent&#xD;
&#xD;
          -  English as a primary language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with communication disorders (linguistic or articulation)&#xD;
&#xD;
          -  Any minor participants for whom parental or legal guardian consent cannot be obtained.&#xD;
&#xD;
          -  Any adult participant for whom Legal Authorized Representative (LAR) consent cannot be&#xD;
             obtained.&#xD;
&#xD;
          -  History of any other serious medical or psychiatric condition that would interfere&#xD;
             with the ability of the patient to complete the study or would make it ethically&#xD;
             unfeasible to enroll them&#xD;
&#xD;
          -  Participants with an intellectual and / or neurocognitive disability that the MHP&#xD;
             deems a barrier to participation&#xD;
&#xD;
          -  Any participant, who at the discretion of the MHP, should not be enrolled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Clarigent Health</name>
      <address>
        <city>Mason</city>
        <state>Ohio</state>
        <zip>45040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clarigent Research</last_name>
      <phone>513-445-3022</phone>
      <email>research@clarigenthealth.com</email>
    </contact>
    <contact_backup>
      <last_name>Joshua I Cohen, PhD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 3, 2022</last_update_submitted>
  <last_update_submitted_qc>August 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Aggression</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
    <mesh_term>Psychological Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493736
org study id: Clarigent 104-2020
nct id: NCT04493736
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Detection of Mental Health State
time frame: 1 year
description: Optimize machine learning models will detect the presence of a mental state as evidenced by scores on standardized tests and clinical assessment.
measure: Demonstrate the Usability of the platform
time frame: 1 year
description: 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.
arm group label: Case
description: 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.
intervention type: Behavioral
intervention name: MHSAFE app recording
description: 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.
arm group label: Case
Audio recorded voice samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 75 Years
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Aggression
mesh term: Suicide, Attempted
mesh term: Psychological Trauma
sharing ipd: Undecided