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Completed

NCT Number: NCT02252471

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

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).

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Key information

Age range

14 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choices-Teen

Behavioral

Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.

Primary outcomes

  1. Risk of alcohol-exposed pregnancy

    Time frame: 3 months

    Timeline Followback Interview

  2. Risk of nicotine-exposed pregnancy

    Time frame: 3 months

    Timeline Followback Interview

  3. HIV risk

    Time frame: 3 months

    Timeline Followback Interview

Secondary outcomes

  1. Excessive alcohol consumption

    Time frame: 3 months

    AUDIT Scale

  2. Psychological distress and symptoms

    Time frame: 3 months

    Brief Symptom Inventory -18

  3. Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)

    Time frame: 3 months

    Decisional Balance Scale

  4. Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)

    Time frame: 3 months

    Processes of Change Questionnaire

  5. Temptation to engage in health risk behaviors (alcohol, smoking, HIV)

    Time frame: 3 months

    Temptation Scale

  6. Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)

    Time frame: 3 months

    Confidence Scale

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 30, 2014
Registry last updated
Sep 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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