<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/NCT01667159</url>
  </required_header>
  <id_info>
    <org_study_id>1R01AA020705-01A1</org_study_id>
    <secondary_id>1R01AA020705-01A1</secondary_id>
    <nct_id>NCT01667159</nct_id>
  </id_info>
  <brief_title>Community-Based Integrated Treatment for Adolescents</brief_title>
  <official_title>Adolescents With Major Depression and AUD: Community-Based Integrated Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</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 examine the effectiveness of an integrated treatment for adolescents who are&#xD;
      depressed and use alcohol in an intensive outpatient setting in the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders&#xD;
      are related in adolescence. For example, in a community sample, teens who reported a history&#xD;
      of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD)&#xD;
      than teens with no history of AUD. The scientific community has only recently begun to&#xD;
      examine how to treat adolescents with both AUD and MDD. Reviews have concluded that&#xD;
      depression negatively affects treatment for substance abuse. At the same time, substance use&#xD;
      issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that&#xD;
      protocols are needed to specifically address substance abusing, depressed adolescents. This&#xD;
      study is designed to determine if an integrated (CBT-I) protocol designed to treat both&#xD;
      substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce&#xD;
      better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and&#xD;
      CBT-SC conditions will be delivered by licensed mental health workers at a community mental&#xD;
      health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat&#xD;
      adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4&#xD;
      years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by&#xD;
      reporting both depressed mood and substance abuse, these eligible families will complete a&#xD;
      thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The&#xD;
      baseline battery will be repeated at the end of treatment, and 6 and 12 months after&#xD;
      treatment completion to determine how families in the study do over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">March 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>Depression</measure>
    <time_frame>Measured at 18 months from baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol/Substance Use</measure>
    <time_frame>Measured at 18 months from baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Depression</condition>
  <condition>Alcohol Use</condition>
  <arm_group>
    <arm_group_label>Integrated Cognitive Behavioral Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated Cognitive Behavioral Therapy</intervention_name>
    <description>Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.</description>
    <arm_group_label>Integrated Cognitive Behavioral Therapy</arm_group_label>
    <other_name>CBT for adolescents and parents</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.</description>
    <arm_group_label>Standard Care</arm_group_label>
    <other_name>Intensive Outpatient Therapy</other_name>
    <other_name>Treatment As Usual (TAU)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking adolescent and parent&#xD;
&#xD;
          -  Current substance use disorder&#xD;
&#xD;
          -  Co-occurring psychiatric symptomatology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ &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, Ph.D.</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>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 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>Depression</keyword>
  <keyword>Alcohol Use</keyword>
  <keyword>Outpatient Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Alcohol Drinking</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/NCT01667159
org study id: 1R01AA020705-01A1
secondary id: 1R01AA020705-01A1
nct id: NCT01667159
lead sponsor: 
collaborator: 
has dmc: Yes
This study will examine the effectiveness of an integrated treatment for adolescents who are
      depressed and use alcohol in an intensive outpatient setting in the community.
Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders
      are related in adolescence. For example, in a community sample, teens who reported a history
      of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD)
      than teens with no history of AUD. The scientific community has only recently begun to
      examine how to treat adolescents with both AUD and MDD. Reviews have concluded that
      depression negatively affects treatment for substance abuse. At the same time, substance use
      issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that
      protocols are needed to specifically address substance abusing, depressed adolescents. This
      study is designed to determine if an integrated (CBT-I) protocol designed to treat both
      substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce
      better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and
      CBT-SC conditions will be delivered by licensed mental health workers at a community mental
      health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat
      adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4
      years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by
      reporting both depressed mood and substance abuse, these eligible families will complete a
      thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The
      baseline battery will be repeated at the end of treatment, and 6 and 12 months after
      treatment completion to determine how families in the study do over time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Depression
time frame: Measured at 18 months from baseline
measure: Alcohol/Substance Use
time frame: Measured at 18 months from baseline
arm group label: Integrated Cognitive Behavioral Therapy
arm group type: Experimental
description: Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.
arm group label: Standard Care
arm group type: Active Comparator
description: Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.
intervention type: Behavioral
intervention name: Integrated Cognitive Behavioral Therapy
description: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.
arm group label: Integrated Cognitive Behavioral Therapy
other name: CBT for adolescents and parents
intervention type: Behavioral
intervention name: Standard Care
description: Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
arm group label: Standard Care
other name: Intensive Outpatient Therapy
other name: Treatment As Usual (TAU)
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Anthony Spirito, Ph.D.
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: Depression
mesh term: Depressive Disorder
mesh term: Alcohol Drinking