<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/NCT01732601</url>
  </required_header>
  <id_info>
    <org_study_id>1R01MH097703-01</org_study_id>
    <secondary_id>1R01MH097703-01</secondary_id>
    <nct_id>NCT01732601</nct_id>
  </id_info>
  <brief_title>Intensive Outpatient Services for Teens</brief_title>
  <acronym>INVEST</acronym>
  <official_title>Intensive Outpatient Protocol for High Risk Suicidal Teens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will identify the effectiveness of an intensive treatment program for teens who&#xD;
      are at high risk for harming themselves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and&#xD;
      inpatient psychiatric hospitalization in this country. These expensive contacts with the&#xD;
      health care system effectively address acute suicidality for many adolescents but there is a&#xD;
      significant subset of suicidal patients that have continued suicidality. This study will&#xD;
      target teens that are at risk for re-hospitalization based on continued suicidal ideation,&#xD;
      their mood and another risk factor such as self-harm or substance use. These risk factors&#xD;
      have been shown to increase risk for continued suicidal behavior and expensive contacts with&#xD;
      the health care system. This protocol has been designed to determine whether Intensive&#xD;
      Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood&#xD;
      disorder, suicidal ideation, and substance use, will result in better treatment outcomes&#xD;
      compared to standard care in the community. The Intensive CBT condition will be delivered by&#xD;
      a team of two licensed mental health therapists over the course of one year and will work&#xD;
      with both the teen and parent. The standard care condition will receive treatment in the&#xD;
      community. One hundred-and fifty adolescents (38 a year) will be recruited from several&#xD;
      inpatient and partial hospital locations. Each adolescent will receive a thorough baseline&#xD;
      assessment to determine whether they are appropriate for the study and will be assigned to&#xD;
      either the Intensive CBT condition or treatment within the community. Both groups of teens&#xD;
      will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing&#xD;
      over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2012</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suicide attempts</measure>
    <time_frame>Measured at 18 months from Baseline</time_frame>
    <description>Self-report by parents or teens of a suicide attempt occurring in the follow-up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressed mood as assessed by the Children's Depression Rating Scale - Revised</measure>
    <time_frame>Measured at 18 months from Baseline</time_frame>
    <description>Depressed mood as determined by clinical interview</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse</measure>
    <time_frame>Measures 18 months from Baseline</time_frame>
    <description>Self report of behaviors considered self-harming including self-inflicted behaviors such as cutting with no suicidal intent or excessive substance use with negative consequences to the individual</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Depression</condition>
  <condition>Suicide</condition>
  <arm_group>
    <arm_group_label>Intensive Outpatient CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive CBT for both parents and adolescents as well as family sessions to increase communication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Treatment in the Community</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Outpatient CBT</intervention_name>
    <description>Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.</description>
    <arm_group_label>Intensive Outpatient CBT</arm_group_label>
    <other_name>Intensive CBT for High Risk Teens with a mood disorder</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Treatment at step-down facilities</description>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Treatment as Usual</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current Mood Disorder and suicidal ideation and one of the following&#xD;
&#xD;
          -  NSSI&#xD;
&#xD;
          -  Suicide Attempt&#xD;
&#xD;
          -  Substance Use&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intelligence Quotient &lt; 80&#xD;
&#xD;
          -  Diagnosis of psychotic disorder, pervasive developmental disorder,&#xD;
             obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa&#xD;
&#xD;
          -  Adolescent use of illicit &quot;hard&quot; substances such as cocaine, heroine, and opiates 13&#xD;
             or more times over the prior 90 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Spirito, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>January 21, 2018</last_update_submitted>
  <last_update_submitted_qc>January 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brown University</investigator_affiliation>
    <investigator_full_name>Anthony Spirito</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Suicide Attempt</keyword>
  <keyword>Suicidal Ideation</keyword>
  <keyword>NSSI</keyword>
  <keyword>Substance Use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <!-- 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/NCT01732601
org study id: 1R01MH097703-01
secondary id: 1R01MH097703-01
nct id: NCT01732601
lead sponsor: 
collaborator: 
has dmc: Yes
This study will identify the effectiveness of an intensive treatment program for teens who
      are at high risk for harming themselves.
Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and
      inpatient psychiatric hospitalization in this country. These expensive contacts with the
      health care system effectively address acute suicidality for many adolescents but there is a
      significant subset of suicidal patients that have continued suicidality. This study will
      target teens that are at risk for re-hospitalization based on continued suicidal ideation,
      their mood and another risk factor such as self-harm or substance use. These risk factors
      have been shown to increase risk for continued suicidal behavior and expensive contacts with
      the health care system. This protocol has been designed to determine whether Intensive
      Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood
      disorder, suicidal ideation, and substance use, will result in better treatment outcomes
      compared to standard care in the community. The Intensive CBT condition will be delivered by
      a team of two licensed mental health therapists over the course of one year and will work
      with both the teen and parent. The standard care condition will receive treatment in the
      community. One hundred-and fifty adolescents (38 a year) will be recruited from several
      inpatient and partial hospital locations. Each adolescent will receive a thorough baseline
      assessment to determine whether they are appropriate for the study and will be assigned to
      either the Intensive CBT condition or treatment within the community. Both groups of teens
      will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing
      over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Suicide attempts
time frame: Measured at 18 months from Baseline
description: Self-report by parents or teens of a suicide attempt occurring in the follow-up period
measure: Depressed mood as assessed by the Children's Depression Rating Scale - Revised
time frame: Measured at 18 months from Baseline
description: Depressed mood as determined by clinical interview
measure: Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse
time frame: Measures 18 months from Baseline
description: Self report of behaviors considered self-harming including self-inflicted behaviors such as cutting with no suicidal intent or excessive substance use with negative consequences to the individual
arm group label: Intensive Outpatient CBT
arm group type: Experimental
description: Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
arm group label: Standard Care
arm group type: Active Comparator
description: Standard Treatment in the Community
intervention type: Behavioral
intervention name: Intensive Outpatient CBT
description: Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.
arm group label: Intensive Outpatient CBT
other name: Intensive CBT for High Risk Teens with a mood disorder
intervention type: Behavioral
intervention name: Standard Care
description: Treatment at step-down facilities
arm group label: Standard Care
other name: Treatment as Usual
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Anthony Spirito, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brown University
investigator full name: Anthony Spirito
investigator title: Professor
mesh term: Suicide