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Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females

Primary Purpose

Alcohol Use, Smoking, Contraception

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Choices-Teen
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Use focused on measuring alcohol-exposed pregnancy, nicotine-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy, HIV, prevention

Eligibility Criteria

14 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Have had vaginal intercourse with a male in the last 90 days
  • Inconsistent/ineffective contraception use
  • Inconsistent/ineffective condom use
  • Drinking at risk levels
  • Smoking
  • Available for the follow-up period

Exclusion Criteria:

  • Pregnant
  • Infertile
  • Insufficient locator information
  • Language other than English

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Choices-Teen Intervention

    Arm 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.

    Outcomes

    Primary Outcome Measures

    Risk of alcohol-exposed pregnancy
    Timeline Followback Interview
    Risk of nicotine-exposed pregnancy
    Timeline Followback Interview
    HIV risk
    Timeline Followback Interview

    Secondary Outcome Measures

    Excessive alcohol consumption
    AUDIT Scale
    Psychological distress and symptoms
    Brief Symptom Inventory -18
    Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
    Decisional Balance Scale
    Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
    Processes of Change Questionnaire
    Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
    Temptation Scale
    Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
    Confidence Scale

    Full Information

    First Posted
    September 20, 2014
    Last Updated
    September 25, 2014
    Sponsor
    University of Houston
    Collaborators
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02252471
    Brief Title
    Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
    Official Title
    Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston
    Collaborators
    The University of Texas Health Science Center, Houston

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use, Smoking, Contraception, HIV
    Keywords
    alcohol-exposed pregnancy, nicotine-exposed pregnancy, tobacco-exposed pregnancy, alcohol, contraception, smoking, pregnancy, HIV, prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Choices-Teen Intervention
    Arm Type
    Experimental
    Arm 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(s)
    Choices-Teen
    Intervention Description
    Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.
    Primary Outcome Measure Information:
    Title
    Risk of alcohol-exposed pregnancy
    Description
    Timeline Followback Interview
    Time Frame
    3 months
    Title
    Risk of nicotine-exposed pregnancy
    Description
    Timeline Followback Interview
    Time Frame
    3 months
    Title
    HIV risk
    Description
    Timeline Followback Interview
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Excessive alcohol consumption
    Description
    AUDIT Scale
    Time Frame
    3 months
    Title
    Psychological distress and symptoms
    Description
    Brief Symptom Inventory -18
    Time Frame
    3 months
    Title
    Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
    Description
    Decisional Balance Scale
    Time Frame
    3 months
    Title
    Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
    Description
    Processes of Change Questionnaire
    Time Frame
    3 months
    Title
    Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
    Description
    Temptation Scale
    Time Frame
    3 months
    Title
    Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
    Description
    Confidence Scale
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have had vaginal intercourse with a male in the last 90 days Inconsistent/ineffective contraception use Inconsistent/ineffective condom use Drinking at risk levels Smoking Available for the follow-up period Exclusion Criteria: Pregnant Infertile Insufficient locator information Language other than English
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danielle E Parrish, Ph.D.
    Organizational Affiliation
    University of Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females

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