xml: <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/NCT05962879</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000985</org_study_id>
      <nct_id>NCT05962879</nct_id>
    </id_info>
    <brief_title>Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness</brief_title>
    <official_title>Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        This research study aims to develop a brief group-based treatment called Resilience Training&#xD;
        for Teens, then to test how well it protects high school students with mild symptoms of&#xD;
        depression, anxiety, or having unusual feelings from developing mental illnesses.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Structured Interview of Psychosis-risk Syndromes (SIPS)</measure>
      <time_frame>1 year</time_frame>
      <description>Subclinical psychotic symptoms that represent a risk of transdiagnostic mental illnesses. This semi-structured interview rates psychotic experiences, general symptoms, and functioning. The SIPS interview assesses positive, negative, disorganized, and general symptoms. The range of the Scale of Psychosis-risk Symptoms (SOPS) is 0-6, with a higher score representing more severe symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Child Behavior Checklist (CBCL)</measure>
      <time_frame>1 year</time_frame>
      <description>Mental health symptoms in the teen rated by both the teen and the parent/guardian consisting of 113 items. The CBCL rates multiple domains across functioning and psychiatric diagnoses. It is scored on a 3-point Likert scale, with higher scores representing more severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global Functioning Social and Role Scales</measure>
      <time_frame>1 year</time_frame>
      <description>Social and school/work functioning captured on this scale rated on a 10 point likert scale assessing functional and social functioning separately. Higher ratings represent richer functioning.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Anxiety Disorders</condition>
    <condition>Psychotic Disorders</condition>
    <condition>Depressive Disorder</condition>
    <condition>Psychosocial Functioning</condition>
    <arm_group>
      <arm_group_label>Resilience Training for Teens</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A one year waitlist period where participants will not participate in Resilience Training for Teens. Following that one year waitlist period, they can participate in Resilience Training for Teens.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Resilience Training for Teens</intervention_name>
      <description>A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.</description>
      <arm_group_label>Resilience Training for Teens</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Currently enrolled in 9th through 12th grade and between the ages of 14 and 19&#xD;
  &#xD;
            -  Endorsed at least one psychotic experience&#xD;
  &#xD;
            -  Provided contact information&#xD;
  &#xD;
            -  Have a parent or legal guardian who is able and willing to provide written informed&#xD;
               consent (if under the age of 18)&#xD;
  &#xD;
            -  Have a parent or legal guardian who is able and willing to participate in a parent&#xD;
               session&#xD;
  &#xD;
            -  Competent and willing to provide written informed assent (if under the age of 18) or&#xD;
               consent (if age 18 or older)&#xD;
  &#xD;
            -  Able to communicate in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently prescribed psychotropic medication (not including medications for attention&#xD;
               deficit/hyperactivity disorder), regardless of adherence&#xD;
  &#xD;
            -  Currently obtaining psychotherapeutic intervention&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nicole R DeTore, PhD</last_name>
      <phone>617-726-2065</phone>
      <email>ndetore@mgh.harvard.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Nicole DeTore, PhD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962879
  org study id: 2023P000985
  nct id: NCT05962879
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research study aims to develop a brief group-based treatment called Resilience Training
        for Teens, then to test how well it protects high school students with mild symptoms of
        depression, anxiety, or having unusual feelings from developing mental illnesses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Structured Interview of Psychosis-risk Syndromes (SIPS)
  time frame: 1 year
  description: Subclinical psychotic symptoms that represent a risk of transdiagnostic mental illnesses. This semi-structured interview rates psychotic experiences, general symptoms, and functioning. The SIPS interview assesses positive, negative, disorganized, and general symptoms. The range of the Scale of Psychosis-risk Symptoms (SOPS) is 0-6, with a higher score representing more severe symptoms.
  measure: Child Behavior Checklist (CBCL)
  time frame: 1 year
  description: Mental health symptoms in the teen rated by both the teen and the parent/guardian consisting of 113 items. The CBCL rates multiple domains across functioning and psychiatric diagnoses. It is scored on a 3-point Likert scale, with higher scores representing more severe symptoms.
  measure: Global Functioning Social and Role Scales
  time frame: 1 year
  description: Social and school/work functioning captured on this scale rated on a 10 point likert scale assessing functional and social functioning separately. Higher ratings represent richer functioning.
  arm group label: Resilience Training for Teens
  arm group type: Experimental
  description: A brief 6-session group-based behavioral intervention for teens at risk of a mental illness.
  arm group label: Waitlist
  arm group type: No Intervention
  description: A one year waitlist period where participants will not participate in Resilience Training for Teens. Following that one year waitlist period, they can participate in Resilience Training for Teens.
  intervention type: Behavioral
  intervention name: Resilience Training for Teens
  description: A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.
  arm group label: Resilience Training for Teens
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Nicole R DeTore, PhD
  phone: 617-726-2065
  email: ndetore@mgh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Nicole DeTore, PhD
  investigator title: Assistant Professor
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  sharing ipd: Undecided