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

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ClinicalTrials.gov Identifier: NCT02252471
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Danielle Parrish, University of Houston

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).

Condition or disease Intervention/treatment Phase
Alcohol Use Smoking Contraception HIV Behavioral: Choices-Teen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
Study Start Date : July 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Choices-Teen Intervention
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.
Behavioral: Choices-Teen
Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252471


Sponsors and Collaborators
University of Houston
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Danielle E Parrish, Ph.D. University of Houston
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Responsible Party: Danielle Parrish, Assistant Professor, University of Houston
ClinicalTrials.gov Identifier: NCT02252471    
Other Study ID Numbers: 1R03DA034099-01 ( U.S. NIH Grant/Contract )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Danielle Parrish, University of Houston:
alcohol-exposed pregnancy
nicotine-exposed pregnancy
tobacco-exposed pregnancy
alcohol
contraception
smoking
pregnancy
HIV
prevention
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior