<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/NCT02252471</url>
  </required_header>
  <id_info>
    <org_study_id>1R03DA034099-01</org_study_id>
    <nct_id>NCT02252471</nct_id>
  </id_info>
  <brief_title>Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females</brief_title>
  <official_title>Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Houston</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with&#xD;
      master's level mental health professionals within a juvenile justice setting; 2) determine&#xD;
      acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment&#xD;
      satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk&#xD;
      of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this study is to assess the feasibility and promise of an adapted&#xD;
      CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV,&#xD;
      nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females&#xD;
      on intensive community probation. The current study posits that a two-session CHOICES&#xD;
      intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be&#xD;
      feasible, acceptable, and promising in reducing these risks among females on community-based&#xD;
      juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception&#xD;
      intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session&#xD;
      individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the&#xD;
      Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm&#xD;
      feasibility trial with females in the juvenile justice system to assess the promise of&#xD;
      CHOICES-TEEN. This pilot study will: 1) demonstrate the feasibility of delivering&#xD;
      CHOICES-TEEN with master's level mental health professionals within a juvenile justice&#xD;
      setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention,&#xD;
      and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g.,&#xD;
      reduction of risk of HIV, NEP, and AEP). This study will inform subsequent Stage II/III&#xD;
      behavioral intervention studies and contribute to a missing, fundamental element in the&#xD;
      knowledge base - further understanding of the feasibility of targeting bundled health risks&#xD;
      in high-risk adolescents, and the potential promise of a gender-specific intervention for&#xD;
      this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Risk of alcohol-exposed pregnancy</measure>
    <time_frame>3 months</time_frame>
    <description>Timeline Followback Interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk of nicotine-exposed pregnancy</measure>
    <time_frame>3 months</time_frame>
    <description>Timeline Followback Interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV risk</measure>
    <time_frame>3 months</time_frame>
    <description>Timeline Followback Interview</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Excessive alcohol consumption</measure>
    <time_frame>3 months</time_frame>
    <description>AUDIT Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress and symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Brief Symptom Inventory -18</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)</measure>
    <time_frame>3 months</time_frame>
    <description>Decisional Balance Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)</measure>
    <time_frame>3 months</time_frame>
    <description>Processes of Change Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temptation to engage in health risk behaviors (alcohol, smoking, HIV)</measure>
    <time_frame>3 months</time_frame>
    <description>Temptation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)</measure>
    <time_frame>3 months</time_frame>
    <description>Confidence Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Alcohol Use</condition>
  <condition>Smoking</condition>
  <condition>Contraception</condition>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Choices-Teen Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A three session intervention with two counseling sessions with a master's level therapist and a counseling session with a physician. The counseling with the master's level therapist utilizes a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, smoking and HIV risk behaviors. This part of the intervention (a) provides norms-based-but personalized-feedback; (b) encourages participating in the smoking cessation program; (c) increases motivation to change each of the target behaviors; (d) decreases temptation to engage in risk behaviors; (e) increases confidence to avoid risk behaviors; and (f) develops a personalized, tailored change plan. The physician session provides individualized contraception and HIV risk reduction counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choices-Teen</intervention_name>
    <description>Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.</description>
    <arm_group_label>Choices-Teen Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have had vaginal intercourse with a male in the last 90 days&#xD;
&#xD;
          -  Inconsistent/ineffective contraception use&#xD;
&#xD;
          -  Inconsistent/ineffective condom use&#xD;
&#xD;
          -  Drinking at risk levels&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Available for the follow-up period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Infertile&#xD;
&#xD;
          -  Insufficient locator information&#xD;
&#xD;
          -  Language other than English&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle E Parrish, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Houston</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Houston</investigator_affiliation>
    <investigator_full_name>Danielle Parrish</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>alcohol-exposed pregnancy</keyword>
  <keyword>nicotine-exposed pregnancy</keyword>
  <keyword>tobacco-exposed pregnancy</keyword>
  <keyword>alcohol</keyword>
  <keyword>contraception</keyword>
  <keyword>smoking</keyword>
  <keyword>pregnancy</keyword>
  <keyword>HIV</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02252471
org study id: 1R03DA034099-01
nct id: NCT02252471
lead sponsor: 
collaborator: 
has dmc: Yes
This pilot study will: 1) demonstrate the feasibility of delivering CHOICES-TEEN with
      master's level mental health professionals within a juvenile justice setting; 2) determine
      acceptance of CHOICES-TEEN as measured by client adherence, retention, and treatment
      satisfaction; and 3) assess client improvement at 3-month follow-up (e.g., reduction of risk
      of HIV, nicotine-exposed pregnancy, and alcohol-exposed pregnancy).
The overall objective of this study is to assess the feasibility and promise of an adapted
      CHOICES preconception intervention (CHOICES-TEEN) in reducing the risk of HIV,
      nicotine-exposed pregnancy (NEP), and alcohol-exposed pregnancy (AEP) in adolescent females
      on intensive community probation. The current study posits that a two-session CHOICES
      intervention adapted to target multiple bundled health risks-AEP, NEP, and HIV-will be
      feasible, acceptable, and promising in reducing these risks among females on community-based
      juvenile probation. This study will: Aim 1: Modify the efficacious CHOICES preconception
      intervention to target the prevention of HIV, AEP, and NEP. The result will be a two session
      individual intervention (CHOICES-TEEN) and accompanying therapy manual based on the
      Transtheoretical Model (TTM) and Motivational Interviewing. Aim 2: Conduct a one-arm
      feasibility trial with females in the juvenile justice system to assess the promise of
      CHOICES-TEEN. This pilot study will: 1) demonstrate the feasibility of delivering
      CHOICES-TEEN with master's level mental health professionals within a juvenile justice
      setting; 2) determine acceptance of CHOICES-TEEN as measured by client adherence, retention,
      and treatment satisfaction; and 3) assess client improvement at 3-month follow-up (e.g.,
      reduction of risk of HIV, NEP, and AEP). This study will inform subsequent Stage II/III
      behavioral intervention studies and contribute to a missing, fundamental element in the
      knowledge base - further understanding of the feasibility of targeting bundled health risks
      in high-risk adolescents, and the potential promise of a gender-specific intervention for
      this population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Risk of alcohol-exposed pregnancy
time frame: 3 months
description: Timeline Followback Interview
measure: Risk of nicotine-exposed pregnancy
time frame: 3 months
description: Timeline Followback Interview
measure: HIV risk
time frame: 3 months
description: Timeline Followback Interview
measure: Excessive alcohol consumption
time frame: 3 months
description: AUDIT Scale
measure: Psychological distress and symptoms
time frame: 3 months
description: Brief Symptom Inventory -18
measure: Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
time frame: 3 months
description: Decisional Balance Scale
measure: Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
time frame: 3 months
description: Processes of Change Questionnaire
measure: Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
time frame: 3 months
description: Temptation Scale
measure: Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
time frame: 3 months
description: Confidence Scale
arm group label: Choices-Teen Intervention
arm group type: Experimental
description: A three session intervention with two counseling sessions with a master's level therapist and a counseling session with a physician. The counseling with the master's level therapist utilizes a motivational interviewing approach to encourage changes in alcohol use, contraceptive use, smoking and HIV risk behaviors. This part of the intervention (a) provides norms-based-but personalized-feedback; (b) encourages participating in the smoking cessation program; (c) increases motivation to change each of the target behaviors; (d) decreases temptation to engage in risk behaviors; (e) increases confidence to avoid risk behaviors; and (f) develops a personalized, tailored change plan. The physician session provides individualized contraception and HIV risk reduction counseling.
intervention type: Behavioral
intervention name: Choices-Teen
description: Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.
arm group label: Choices-Teen Intervention
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: No
last name: Danielle E Parrish, Ph.D.
role: Principal Investigator
affiliation: University of Houston
responsible party type: Principal Investigator
investigator affiliation: University of Houston
investigator full name: Danielle Parrish
investigator title: Assistant Professor
mesh term: Alcohol Drinking