<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/NCT02228044</url>
  </required_header>
  <id_info>
    <org_study_id>5970</org_study_id>
    <secondary_id>R01AA016854</secondary_id>
    <nct_id>NCT02228044</nct_id>
  </id_info>
  <brief_title>Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment</brief_title>
  <official_title>Alcohol, Suicide, and HIV Prevention for Teens in Mental Health Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Mason 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>George Mason University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines whether an integrated alcohol/substance abuse, suicide, and HIV&#xD;
      prevention protocol is associated with lower onset and frequency of alcohol and other drug&#xD;
      use, suicidal behavior, and high risk sexual behavior among adolescents receiving community&#xD;
      based mental health care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and&#xD;
      HIV prevention program to an assessment only control condition in a randomized clinical&#xD;
      trial. This prevention protocol is designed as an &quot;add-on&quot; intervention to standard mental&#xD;
      health care. We will examine the extent to which the addition of this prevention protocol is&#xD;
      associated with lower rates of alcohol use and drug use, suicidal behavior, and HIV related&#xD;
      risk behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adolescent alcohol use and binge drinking (any, number of days, number of related problems)</measure>
    <time_frame>change from baseline to 6 months (prior 3 months)</time_frame>
    <description>This was assessed using the Customary Drinking and Drug Use Record</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)</measure>
    <time_frame>change from baseline to 6 months (prior month to 6 months)</time_frame>
    <description>This was assessed using the Suicidal ideation Questionnaire and the Self-Injurious Thoughts and Behavior Interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)</measure>
    <time_frame>change from baseline to 6 months (prior 3 months)</time_frame>
    <description>This was assessed using the Adolescent Risk Behavior Assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent marijuana use (any use, number of days, related problems)</measure>
    <time_frame>change from baseline to 6 months (prior 3 months)</time_frame>
    <description>This was assessed with the Customary Drinking and Drug Use Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent alcohol use and binge drinking (any, number of days, number of related problems)</measure>
    <time_frame>change from baseline to 12 months (prior 3 months)</time_frame>
    <description>This was assessed using the Customary Drinking and Drug Use Measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)</measure>
    <time_frame>change from baseline to 12 months (prior month to 6 months)</time_frame>
    <description>This was assessed with the Suicidal Ideation Questionnaire and the Self-Injurious Thoughts and Behavior Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)</measure>
    <time_frame>change from baseline to 12 months (prior 3 months)</time_frame>
    <description>This was assessed with the Adolescent Risk Behavior Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>adolescent marijuana use (any use, number of days, related problems)</measure>
    <time_frame>change from baseline to 12 months (prior 3 months)</time_frame>
    <description>This was assessed with the Customary Drinking and Drug Use Record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frequency of parental monitoring behavior</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Parental Monitoring Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of parent-child communication around high risk behaviors</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perceptions of parental degree of disapproval of high risk behavior</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perception of degree of interpersonal coping and stress management skills</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent degree of perceived self-efficacy for condom use</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Self-Efficacy for Condom Use Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent degree of HIV related knowledge</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the HIV Knowledge Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perceptions of degree of peer substance use and tolerance of use</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with Peer Substance Use and Tolerance of Use scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perception of the degree of peer approval of sexual activity</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with the Peer Norms Scale for Sexual Activity scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent degree of perceived self-efficacy for HIV prevention</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Self-Efficacy for HIV Prevention Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of positive and negative thoughts related to suicide</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Positive and Negative Suicide Ideation Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of adolescent positive/negative attitudes and beliefs about alcohol</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Youth Alcohol and Drug Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of adolescent positive/negative attitudes and beliefs about marijuana use</measure>
    <time_frame>change from baseline to 1 month</time_frame>
    <description>This was assessed with the Youth Alcohol and Drug Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of parental monitoring behavior</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with the parental monitoring questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of parental monitoring behavior</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with the parental monitoring questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of parent-child communication around high risk behaviors</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of parent-child communication around high risk behaviors</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perceptions of parental degree of disapproval of high risk behavior</measure>
    <time_frame>change from baseline to 6 months</time_frame>
    <description>This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perceptions of parental degree of disapproval of high risk behavior</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perception of degree of interpersonal and stress management coping skills</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perceptions of degree of peer substance use and approval of use</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with Peer Substance Use and Tolerance of Use scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adolescent perception of the degree of peer approval of sexual activity</measure>
    <time_frame>change from baseline to 12 months</time_frame>
    <description>This was assessed with the Peer Norms Scale for Sexual Activity scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Suicide</condition>
  <condition>Alcohol Abuse</condition>
  <condition>Drug Abuse</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Prevention Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a cognitive-behavioral substance abuse, suicide, and HIV prevention program delivered in a workshop format to adolescent participants and their parents/legal guardians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prevention program</intervention_name>
    <arm_group_label>Prevention Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages 13-18&#xD;
&#xD;
          -  English speaking adolescent and at least one English speaking parent&#xD;
&#xD;
          -  receiving mental health treatment&#xD;
&#xD;
          -  living with a parent or guardian willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active Alcohol or Marijuana Dependence Diagnosis&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Current psychosis&#xD;
&#xD;
          -  Cognitively unable to give assent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christianne Esposito-Smythers, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Mason University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Mason University</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 25, 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>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>suicide</keyword>
  <keyword>alcohol</keyword>
  <keyword>marijuana</keyword>
  <keyword>HIV</keyword>
  <keyword>prevention</keyword>
  <keyword>adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
    <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/NCT02228044
org study id: 5970
secondary id: R01AA016854
nct id: NCT02228044
lead sponsor: 
collaborator: 
has dmc: Yes
This study examines whether an integrated alcohol/substance abuse, suicide, and HIV
      prevention protocol is associated with lower onset and frequency of alcohol and other drug
      use, suicidal behavior, and high risk sexual behavior among adolescents receiving community
      based mental health care.
The purpose of this study is to compare an integrated adolescent alcohol/drug, suicide, and
      HIV prevention program to an assessment only control condition in a randomized clinical
      trial. This prevention protocol is designed as an "add-on" intervention to standard mental
      health care. We will examine the extent to which the addition of this prevention protocol is
      associated with lower rates of alcohol use and drug use, suicidal behavior, and HIV related
      risk behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: adolescent alcohol use and binge drinking (any, number of days, number of related problems)
time frame: change from baseline to 6 months (prior 3 months)
description: This was assessed using the Customary Drinking and Drug Use Record
measure: adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
time frame: change from baseline to 6 months (prior month to 6 months)
description: This was assessed using the Suicidal ideation Questionnaire and the Self-Injurious Thoughts and Behavior Interview
measure: adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
time frame: change from baseline to 6 months (prior 3 months)
description: This was assessed using the Adolescent Risk Behavior Assessment.
measure: adolescent marijuana use (any use, number of days, related problems)
time frame: change from baseline to 6 months (prior 3 months)
description: This was assessed with the Customary Drinking and Drug Use Measure
measure: adolescent alcohol use and binge drinking (any, number of days, number of related problems)
time frame: change from baseline to 12 months (prior 3 months)
description: This was assessed using the Customary Drinking and Drug Use Measure
measure: adolescent suicidal ideation and behavior (severity of suicidal ideation and presence of any suicidal ideation or suicidal behavior)
time frame: change from baseline to 12 months (prior month to 6 months)
description: This was assessed with the Suicidal Ideation Questionnaire and the Self-Injurious Thoughts and Behavior Questionnaire
measure: adolescent HIV risk behavior (any sexual behavior, number of sexual partners, number of unprotected sexual acts)
time frame: change from baseline to 12 months (prior 3 months)
description: This was assessed with the Adolescent Risk Behavior Assessment
measure: adolescent marijuana use (any use, number of days, related problems)
time frame: change from baseline to 12 months (prior 3 months)
description: This was assessed with the Customary Drinking and Drug Use Record
measure: frequency of parental monitoring behavior
time frame: change from baseline to 1 month
description: This was assessed with the Parental Monitoring Questionnaire
measure: quality of parent-child communication around high risk behaviors
time frame: change from baseline to 1 month
description: This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
time frame: change from baseline to 1 month
description: This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
measure: adolescent perception of degree of interpersonal coping and stress management skills
time frame: change from baseline to 6 months
description: This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
measure: adolescent degree of perceived self-efficacy for condom use
time frame: change from baseline to 1 month
description: This was assessed with the Self-Efficacy for Condom Use Scale
measure: adolescent degree of HIV related knowledge
time frame: change from baseline to 1 month
description: This was assessed with the HIV Knowledge Scale
measure: adolescent perceptions of degree of peer substance use and tolerance of use
time frame: change from baseline to 6 months
description: This was assessed with Peer Substance Use and Tolerance of Use scale
measure: adolescent perception of the degree of peer approval of sexual activity
time frame: change from baseline to 6 months
description: This was assessed with the Peer Norms Scale for Sexual Activity scale
measure: adolescent degree of perceived self-efficacy for HIV prevention
time frame: change from baseline to 1 month
description: This was assessed with the Self-Efficacy for HIV Prevention Scale
measure: frequency of positive and negative thoughts related to suicide
time frame: change from baseline to 1 month
description: This was assessed with the Positive and Negative Suicide Ideation Inventory
measure: degree of adolescent positive/negative attitudes and beliefs about alcohol
time frame: change from baseline to 1 month
description: This was assessed with the Youth Alcohol and Drug Survey
measure: degree of adolescent positive/negative attitudes and beliefs about marijuana use
time frame: change from baseline to 1 month
description: This was assessed with the Youth Alcohol and Drug Survey
measure: frequency of parental monitoring behavior
time frame: change from baseline to 6 months
description: This was assessed with the parental monitoring questionnaire
measure: frequency of parental monitoring behavior
time frame: change from baseline to 12 months
description: This was assessed with the parental monitoring questionnaire
measure: quality of parent-child communication around high risk behaviors
time frame: change from baseline to 6 months
description: This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
measure: quality of parent-child communication around high risk behaviors
time frame: change from baseline to 12 months
description: This was assessed with the Parent-Adolescent Sexual Communication Scale and items adapted for alcohol/drug use and suicidal behavior
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
time frame: change from baseline to 6 months
description: This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
measure: adolescent perceptions of parental degree of disapproval of high risk behavior
time frame: change from baseline to 12 months
description: This was assessed with Parental Norms for Sexual Activity and Supervision Scale and items adapted for alcohol/drug use
measure: adolescent perception of degree of interpersonal and stress management coping skills
time frame: change from baseline to 12 months
description: This was assessed with the Bar-On Emotional Quotient Inventory - Youth Version
measure: adolescent perceptions of degree of peer substance use and approval of use
time frame: change from baseline to 12 months
description: This was assessed with Peer Substance Use and Tolerance of Use scale
measure: adolescent perception of the degree of peer approval of sexual activity
time frame: change from baseline to 12 months
description: This was assessed with the Peer Norms Scale for Sexual Activity scale
arm group label: Prevention Program
arm group type: Experimental
description: This is a cognitive-behavioral substance abuse, suicide, and HIV prevention program delivered in a workshop format to adolescent participants and their parents/legal guardians.
arm group label: Assessment Only
arm group type: No Intervention
intervention type: Behavioral
intervention name: Prevention program
arm group label: Prevention Program
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: Christianne Esposito-Smythers, Ph.D.
role: Principal Investigator
affiliation: George Mason University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
mesh term: Substance-Related Disorders
mesh term: Suicide