<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/NCT02227589</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00053448</org_study_id>
    <secondary_id>1R01AA021719-01A1</secondary_id>
    <secondary_id>1R01AA021735-01A1</secondary_id>
    <nct_id>NCT02227589</nct_id>
  </id_info>
  <brief_title>Treatment for Teens With Alcohol Abuse and Depression</brief_title>
  <acronym>T-TAAD</acronym>
  <official_title>Treatment for Teens With Alcohol Abuse and Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will recruit adolescents with alcohol or cannabis abuse and clinically&#xD;
      significant depression. All participants will receive 12 sessions of an evidence-based&#xD;
      treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12,&#xD;
      over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to&#xD;
      receive treatment augmentation with either an integrated cognitive behavior therapy for&#xD;
      depression, delivered by their study therapist, or depression treatment-as-usual in the&#xD;
      community. The study hypothesis is that integrated depression treatment will surpass&#xD;
      community treatment-as-usual in efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Alcohol and other substance use disorders (AOSUDs), primarily cannabis use disorders,&#xD;
      continue to be a significant public health concern among American adolescents. AOSUDs are&#xD;
      commonly accompanied by co-occurring psychiatric disorders including depression. This&#xD;
      comorbidity has been associated with increased severity of AOSUD, earlier treatment&#xD;
      termination, poorer outcomes, and increased suicidal risk. Presently there is neither a&#xD;
      consensus nor a standard, evidence-based intervention to address the need for an effective&#xD;
      and feasible treatment for both disorders. However, cognitive behavior therapy (CBT) has been&#xD;
      found to be effective for each of these disorders, separately. In addition, in some, but not&#xD;
      all, adolescents with both disorders, depression appears to respond rapidly to CBT that&#xD;
      targets only alcohol or substance abuse. This suggests that early depression responders&#xD;
      (EDRs) may not need additional treatment that targets depression directly, unlike their&#xD;
      non-early responding (NEDR) counterparts. However, no studies have compared longer term&#xD;
      outcomes of adolescent EDRs to NEDRs. Moreover, no randomized, controlled studies have tested&#xD;
      the hypothesis that an integrated CBT intervention for co-occurring AOSUD and depression will&#xD;
      be effective for both disorders, in NEDR adolescents.&#xD;
&#xD;
      In this two-site study, submitted in response to PA: PAS-10-251, we will recruit 170 eligible&#xD;
      adolescents (102 at the University of Connecticut and 68 at Duke University), ages 13 years&#xD;
      to 21 years-11 months, with alcohol or cannabis use disorders and clinically significant&#xD;
      depression. All subjects will receive 12 sessions of Motivation Enhancement Therapy/Cognitive&#xD;
      Behavior Therapy (MET/CBT-12), a standard, evidence-based intervention for alcohol or drug&#xD;
      abuse over 12 to 14 weeks. After four weeks, NEDR adolescents will be randomized to&#xD;
      depression treatment augmentation, either with seven sessions of CBT (CBT-D), integrated with&#xD;
      MET/CBT-12, or with enhanced depression-treatment-as-usual in the community (D-ETAU). We&#xD;
      estimate that 120 adolescents will be randomized; we will stratify randomization on gender,&#xD;
      age, and presence/absence of a Major Depressive Episode. We will assess all 170 participants&#xD;
      at baseline, weeks 4, 9, and 14 (after treatment), and at 3-, 6-, and 9-month follow-up.&#xD;
&#xD;
      The first aim of this study is to describe the percentage of depressed AOSUD adolescents who&#xD;
      demonstrate EDR during alcohol or cannabis abuse treatment alone, examine EDR durability and&#xD;
      EDR predictors. The second and third aims test the hypotheses that, for NEDR teens, an&#xD;
      integrated treatment augmentation (CBT-D) will lead to better depression and alcohol or&#xD;
      cannabis outcomes, respectively, than augmentation with D-ETAU. We will compare outcomes of&#xD;
      all three groups (EDRs; and NEDRs in each augmentation), on alcohol use, depressive symptoms,&#xD;
      alcohol- or cannabis-related functional impairment, maintenance of alcohol or cannabis&#xD;
      treatment gains, and depression remission rates over time, and will analyze the temporal&#xD;
      ordering of changes in alcohol or cannabis use and depression during and after treatment.&#xD;
      This is the first study to test an adaptive treatment model with depressed alcohol or&#xD;
      cannabis use disorder youths, and thus has significant potential to guide clinical practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2015</start_date>
  <completion_date type="Actual">January 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 3, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Duke site has masked outcomes assessor; University of Connecticut site does not have masked outcomes assessor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol use frequency assessed with the Alcohol Consumption Questionnaire</measure>
    <time_frame>Change from baseline to week 14; change from baseline to 9 months after treatment ends</time_frame>
    <description>At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator using the Alcohol Consumption Questionnaire regarding alcohol use frequency over the past three months (baseline, and months 3, 6, and 9) or past month (weeks 4, 9, and 14).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of depression, as measured on the Children's Depression Rating Scale-Revised (CDRS-R)</measure>
    <time_frame>Change from baseline to week 4; Change from baseline to week 14; Change from baseline to 9 months after treatment ends</time_frame>
    <description>At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment] and then 3, 6, and 9 months after treatment ends, adolescents and parents will be interviewed by an independent evaluator using the CDRS-R, with reference to the adolescent's depression symptoms during the past week. The week 4 assessment determines whether the adolescent is an early responder on depression, defined as having a 50% reduction in CDRS-R score. One item assesses suicidal thinking or behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Alcohol use quantity assessed with the Alcohol Consumption Questionnaire</measure>
    <time_frame>Change from baseline to week 14; Change from baseline to 9 months after treatment ends</time_frame>
    <description>At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding alcohol use quantity over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Alcohol Consumption Questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cannabis use frequency assessed with the Drug Checklist</measure>
    <time_frame>Change from baseline to week 14; Change from baseline to 9 months after treatment ends</time_frame>
    <description>At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding cannabis use frequency over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Drug Checklist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnosis</measure>
    <time_frame>Baseline to Week 14; baseline to 9 Months after treatment ends</time_frame>
    <description>At baseline, week 14 (end of treatment), and 9 months after treatment, the adolescent will complete the Voice DISC diagnostic interview to determine whether he or she continues to meet criteria for an alcohol or cannabis use disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Teen-Addiction Severity Index (T-ASI)</measure>
    <time_frame>Baseline to Week 14; baseline to 9 months after treatment ends</time_frame>
    <description>The Independent Evaluator will complete the T-ASI with the adolescent and parent at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine whether there are changes in substance-use-related functional problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)</measure>
    <time_frame>Baseline to Week 14; baseline to 9 months after treatment ends</time_frame>
    <description>Adolescents will complete this self-report form at every assessment point (baseline, week 4, week, 9, week 14; and then 3, 6, and 9 months after treatment ends) to determine if there are significant reductions in suicidal ideation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Global Assessment of Functioning (CGAS)</measure>
    <time_frame>Baseline to Week 14; baseline to 9 months after treatment ends</time_frame>
    <description>The Independent Evaluator will make this single item rating of global functioning at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine if there are significant improvements in adolescent's overall functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Improvement in Depression (CGI-I)</measure>
    <time_frame>Baseline to Week 14; baseline to 9 months after treatment ends</time_frame>
    <description>At every assessment point except baseline (at week 4, week 9, week 14, and then at 3, 6, and 9 months after treatment ends), the independent evaluator will rate the adolescent's improvement since baseline in the domain of depression, using CDRS-R scores as the reference. The CGI-I score determines whether the adolescent is a partial or full responder, or a non-responder to treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>Baseline to Week 14; baseline to 9 months after treatment ends</time_frame>
    <description>Adolescents will complete this self-report measure of depression severity at all assessment points (baseline, week 4, week 9, week 14; and then 3, 6, and 9 months after treatment ends) to determine if there has been a significant reduction in severity of depressive symptoms. One item assesses suicidal ideation or intent.</description>
  </other_outcome>
  <other_outcome>
    <measure>Situational Confidence Questionnaire (SCQ)</measure>
    <time_frame>Baseline to Week 14</time_frame>
    <description>At baseline, week 4, and week 14, the adolescent will self-report perceived self-efficacy to manage potentially stressful situations involving alcohol or cannabis, to determine if this confidence increases during treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Urine analysis</measure>
    <time_frame>From baseline through month 9 of follow-up</time_frame>
    <description>At every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends), and 8 additional times during treatment, adolescents will complete a 6-panel iCUP Drug Screen Test to check for non-alcohol substance use.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>AOD Use, Abuse, and Dependence</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>MET/CBT-12 plus CBT-D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBT-D is an integrated cognitive behavior therapy targeting depression, delivered by the same study therapist who delivers MET/CBT-12 to the adolescent. All adolescents receiving CBT-D remain in MET/CBT-12 with their study provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MET/CBT-12 plus D-TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>D-TAU (Depression Treatment as Usual) consists of referral to a depression treatment provider in the community. In this study D-TAU will be enhanced by assistance from the study team in locating providers and, with consent, an assessment report about the adolescent from the study team to the provider. All adolescents receiving TAU for depression remain in MET/CBT-12 with their study provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MET/CBT-12 alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MET/CBT-12 consists of two sessions of motivation enhancement therapy and 10 sessions of cognitive behavior therapy, targeting alcohol or cannabis abuse. All adolescents in the study receive MET/CBT-12 over 12 to 14 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MET/CBT-12</intervention_name>
    <description>Two sessions of motivation enhancement therapy followed by 10 sessions of cognitive behavior therapy targeting alcohol or cannabis abuse. These 12 sessions will be delivered over 12 to 14 weeks.</description>
    <arm_group_label>MET/CBT-12 alone</arm_group_label>
    <arm_group_label>MET/CBT-12 plus CBT-D</arm_group_label>
    <arm_group_label>MET/CBT-12 plus D-TAU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT-D</intervention_name>
    <description>CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.</description>
    <arm_group_label>MET/CBT-12 plus CBT-D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>D-TAU</intervention_name>
    <description>D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.</description>
    <arm_group_label>MET/CBT-12 plus D-TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 13 years to 21 years, 11 months at baseline&#xD;
&#xD;
          -  Current alcohol or cannabis abuse or dependence diagnosis (DSM-IV) OR current level of&#xD;
             potentially harmful drinking or cannabis use as evidenced by (1) consumption of 4 or&#xD;
             more drinks per drinking day (males) or three or more (females), or use of cannabis at&#xD;
             least three times in past 90 days (or before admission into a controlled environment)&#xD;
&#xD;
          -  Current clinically significant depression, defined as a score of 40 or more on the&#xD;
             Children's Depression Rating Scale-Revised at baseline&#xD;
&#xD;
          -  If currently taking anti-depressant medication, on a stable dose for at least one&#xD;
             month&#xD;
&#xD;
          -  Willingness to accept treatment&#xD;
&#xD;
          -  Able to speak and read English (5th-grade level)&#xD;
&#xD;
          -  Residence within 45-minute drive from treatment site&#xD;
&#xD;
          -  Adolescent and a parent agree to sign Institutional Review Board approved&#xD;
             consent/assent form; for subjects ages 18-19, parent involvement is optional and is&#xD;
             the decision of the youth&#xD;
&#xD;
          -  Parent/guardian agrees to provide collateral information and to designate two third&#xD;
             parties who could be contacted in case the subject is lost to follow-up; for subjects&#xD;
             ages 18-19, the participating youth will provide this information&#xD;
&#xD;
          -  Participant (and parent, if youth is under age 18) not planning to move outside the&#xD;
             area in the next 9 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suicidal ideation with a plan, or suicide attempt within 30 days. In addition to such&#xD;
             suicide risk being indicated in baseline interview material, a score exceeding the&#xD;
             89th percentile on the Suicide Ideation Questionnaire (SIQ-Jr), will necessitate an&#xD;
             immediate risk assessment by the Independent Evaluator which may lead to exclusion&#xD;
             under this criterion.&#xD;
&#xD;
          -  Homicidal ideation with a plan or any plan to hurt others&#xD;
&#xD;
          -  Lifetime diagnosis of psychosis, schizophrenia, bipolar disorder, intellectual&#xD;
             disability or autistic disorder&#xD;
&#xD;
          -  Current dependence on a substance other than alcohol, marijuana or nicotine&#xD;
&#xD;
          -  Current non-alcohol or cannabis use disorder or depression primary diagnosis, i.e.,&#xD;
             the diagnosis requires care more urgently than does alcohol or cannabis use disorder&#xD;
             or depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>263 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John F Curry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yifrah Kaminer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UConn Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Connecticut Health Center</name>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <zip>06030-3926</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Child and Family Study Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adolescent,</keyword>
  <keyword>alcohol abuse</keyword>
  <keyword>depression,</keyword>
  <keyword>cognitive behavior therapy</keyword>
  <keyword>cannabis abuse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02227589
org study id: Pro00053448
secondary id: 1R01AA021719-01A1
secondary id: 1R01AA021735-01A1
nct id: NCT02227589
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators will recruit adolescents with alcohol or cannabis abuse and clinically
      significant depression. All participants will receive 12 sessions of an evidence-based
      treatment for alcohol abuse, Motivation Enhancement Therapy/Cognitive Behavior Therapy-12,
      over 12 to 14 weeks. Those who are still depressed after 4 weeks will be randomized to
      receive treatment augmentation with either an integrated cognitive behavior therapy for
      depression, delivered by their study therapist, or depression treatment-as-usual in the
      community. The study hypothesis is that integrated depression treatment will surpass
      community treatment-as-usual in efficacy.
Alcohol and other substance use disorders (AOSUDs), primarily cannabis use disorders,
      continue to be a significant public health concern among American adolescents. AOSUDs are
      commonly accompanied by co-occurring psychiatric disorders including depression. This
      comorbidity has been associated with increased severity of AOSUD, earlier treatment
      termination, poorer outcomes, and increased suicidal risk. Presently there is neither a
      consensus nor a standard, evidence-based intervention to address the need for an effective
      and feasible treatment for both disorders. However, cognitive behavior therapy (CBT) has been
      found to be effective for each of these disorders, separately. In addition, in some, but not
      all, adolescents with both disorders, depression appears to respond rapidly to CBT that
      targets only alcohol or substance abuse. This suggests that early depression responders
      (EDRs) may not need additional treatment that targets depression directly, unlike their
      non-early responding (NEDR) counterparts. However, no studies have compared longer term
      outcomes of adolescent EDRs to NEDRs. Moreover, no randomized, controlled studies have tested
      the hypothesis that an integrated CBT intervention for co-occurring AOSUD and depression will
      be effective for both disorders, in NEDR adolescents.

      In this two-site study, submitted in response to PA: PAS-10-251, we will recruit 170 eligible
      adolescents (102 at the University of Connecticut and 68 at Duke University), ages 13 years
      to 21 years-11 months, with alcohol or cannabis use disorders and clinically significant
      depression. All subjects will receive 12 sessions of Motivation Enhancement Therapy/Cognitive
      Behavior Therapy (MET/CBT-12), a standard, evidence-based intervention for alcohol or drug
      abuse over 12 to 14 weeks. After four weeks, NEDR adolescents will be randomized to
      depression treatment augmentation, either with seven sessions of CBT (CBT-D), integrated with
      MET/CBT-12, or with enhanced depression-treatment-as-usual in the community (D-ETAU). We
      estimate that 120 adolescents will be randomized; we will stratify randomization on gender,
      age, and presence/absence of a Major Depressive Episode. We will assess all 170 participants
      at baseline, weeks 4, 9, and 14 (after treatment), and at 3-, 6-, and 9-month follow-up.

      The first aim of this study is to describe the percentage of depressed AOSUD adolescents who
      demonstrate EDR during alcohol or cannabis abuse treatment alone, examine EDR durability and
      EDR predictors. The second and third aims test the hypotheses that, for NEDR teens, an
      integrated treatment augmentation (CBT-D) will lead to better depression and alcohol or
      cannabis outcomes, respectively, than augmentation with D-ETAU. We will compare outcomes of
      all three groups (EDRs; and NEDRs in each augmentation), on alcohol use, depressive symptoms,
      alcohol- or cannabis-related functional impairment, maintenance of alcohol or cannabis
      treatment gains, and depression remission rates over time, and will analyze the temporal
      ordering of changes in alcohol or cannabis use and depression during and after treatment.
      This is the first study to test an adaptive treatment model with depressed alcohol or
      cannabis use disorder youths, and thus has significant potential to guide clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Duke site has masked outcomes assessor; University of Connecticut site does not have masked outcomes assessor
measure: Alcohol use frequency assessed with the Alcohol Consumption Questionnaire
time frame: Change from baseline to week 14; change from baseline to 9 months after treatment ends
description: At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator using the Alcohol Consumption Questionnaire regarding alcohol use frequency over the past three months (baseline, and months 3, 6, and 9) or past month (weeks 4, 9, and 14).
measure: Severity of depression, as measured on the Children's Depression Rating Scale-Revised (CDRS-R)
time frame: Change from baseline to week 4; Change from baseline to week 14; Change from baseline to 9 months after treatment ends
description: At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment] and then 3, 6, and 9 months after treatment ends, adolescents and parents will be interviewed by an independent evaluator using the CDRS-R, with reference to the adolescent's depression symptoms during the past week. The week 4 assessment determines whether the adolescent is an early responder on depression, defined as having a 50% reduction in CDRS-R score. One item assesses suicidal thinking or behavior.
measure: Alcohol use quantity assessed with the Alcohol Consumption Questionnaire
time frame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
description: At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding alcohol use quantity over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Alcohol Consumption Questionnaire.
measure: Cannabis use frequency assessed with the Drug Checklist
time frame: Change from baseline to week 14; Change from baseline to 9 months after treatment ends
description: At every assessment point (baseline, weeks 4, 9, and 14 [end of treatment]; and then 3, 6, and 9 months after treatment ends, adolescents will be interviewed by an independent evaluator regarding cannabis use frequency over the past three months (baseline; months 3, 6, and 9) or past month (weeks 4, 9, and 14), using the Drug Checklist.
measure: Diagnosis
time frame: Baseline to Week 14; baseline to 9 Months after treatment ends
description: At baseline, week 14 (end of treatment), and 9 months after treatment, the adolescent will complete the Voice DISC diagnostic interview to determine whether he or she continues to meet criteria for an alcohol or cannabis use disorder
measure: Teen-Addiction Severity Index (T-ASI)
time frame: Baseline to Week 14; baseline to 9 months after treatment ends
description: The Independent Evaluator will complete the T-ASI with the adolescent and parent at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine whether there are changes in substance-use-related functional problems
measure: Suicidal Ideation Questionnaire-Jr. High Version (SIQ-Jr)
time frame: Baseline to Week 14; baseline to 9 months after treatment ends
description: Adolescents will complete this self-report form at every assessment point (baseline, week 4, week, 9, week 14; and then 3, 6, and 9 months after treatment ends) to determine if there are significant reductions in suicidal ideation
measure: Children's Global Assessment of Functioning (CGAS)
time frame: Baseline to Week 14; baseline to 9 months after treatment ends
description: The Independent Evaluator will make this single item rating of global functioning at every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends) to determine if there are significant improvements in adolescent's overall functioning
measure: Clinical Global Impression-Improvement in Depression (CGI-I)
time frame: Baseline to Week 14; baseline to 9 months after treatment ends
description: At every assessment point except baseline (at week 4, week 9, week 14, and then at 3, 6, and 9 months after treatment ends), the independent evaluator will rate the adolescent's improvement since baseline in the domain of depression, using CDRS-R scores as the reference. The CGI-I score determines whether the adolescent is a partial or full responder, or a non-responder to treatment.
measure: Beck Depression Inventory-II (BDI-II)
time frame: Baseline to Week 14; baseline to 9 months after treatment ends
description: Adolescents will complete this self-report measure of depression severity at all assessment points (baseline, week 4, week 9, week 14; and then 3, 6, and 9 months after treatment ends) to determine if there has been a significant reduction in severity of depressive symptoms. One item assesses suicidal ideation or intent.
measure: Situational Confidence Questionnaire (SCQ)
time frame: Baseline to Week 14
description: At baseline, week 4, and week 14, the adolescent will self-report perceived self-efficacy to manage potentially stressful situations involving alcohol or cannabis, to determine if this confidence increases during treatment
measure: Urine analysis
time frame: From baseline through month 9 of follow-up
description: At every assessment point (baseline, week 4, week 9, week 14, and then 3, 6, and 9 months after treatment ends), and 8 additional times during treatment, adolescents will complete a 6-panel iCUP Drug Screen Test to check for non-alcohol substance use.
arm group label: MET/CBT-12 plus CBT-D
arm group type: Experimental
description: CBT-D is an integrated cognitive behavior therapy targeting depression, delivered by the same study therapist who delivers MET/CBT-12 to the adolescent. All adolescents receiving CBT-D remain in MET/CBT-12 with their study provider.
arm group label: MET/CBT-12 plus D-TAU
arm group type: Active Comparator
description: D-TAU (Depression Treatment as Usual) consists of referral to a depression treatment provider in the community. In this study D-TAU will be enhanced by assistance from the study team in locating providers and, with consent, an assessment report about the adolescent from the study team to the provider. All adolescents receiving TAU for depression remain in MET/CBT-12 with their study provider.
arm group label: MET/CBT-12 alone
arm group type: Active Comparator
description: MET/CBT-12 consists of two sessions of motivation enhancement therapy and 10 sessions of cognitive behavior therapy, targeting alcohol or cannabis abuse. All adolescents in the study receive MET/CBT-12 over 12 to 14 weeks.
intervention type: Behavioral
intervention name: MET/CBT-12
description: Two sessions of motivation enhancement therapy followed by 10 sessions of cognitive behavior therapy targeting alcohol or cannabis abuse. These 12 sessions will be delivered over 12 to 14 weeks.
arm group label: MET/CBT-12 alone
arm group label: MET/CBT-12 plus CBT-D
arm group label: MET/CBT-12 plus D-TAU
intervention type: Behavioral
intervention name: CBT-D
description: CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.
arm group label: MET/CBT-12 plus CBT-D
intervention type: Other
intervention name: D-TAU
description: D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.
arm group label: MET/CBT-12 plus D-TAU
criteria: 
gender: All
minimum age: 13 Years
maximum age: 263 Months
healthy volunteers: No
last name: John F Curry, PhD
role: Principal Investigator
affiliation: Duke University
last name: Yifrah Kaminer, M.D.
role: Principal Investigator
affiliation: UConn Health
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Depression
mesh term: Depressive Disorder