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Clinical Trials/NCT02252471
NCT02252471CompletedNot Applicable

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

University of Houston0 sites28 target enrollmentStarted: July 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Primary Endpoint
Risk of nicotine-exposed pregnancy

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
14 Years to 17 Years (Child)
Sex
Female
Accepts Healthy Volunteers
No

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
  • •Available for the follow-up period

Exclusion Criteria

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

Arms & Interventions

Choices-Teen Intervention

Experimental

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: Choices-Teen (Behavioral)

Outcomes

Primary Outcomes

Risk of nicotine-exposed pregnancy

Time Frame: 3 months

Timeline Followback Interview

Risk of alcohol-exposed pregnancy

Time Frame: 3 months

Timeline Followback Interview

HIV risk

Time Frame: 3 months

Timeline Followback Interview

Secondary Outcomes

  • Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)(3 months)
  • Excessive alcohol consumption(3 months)
  • Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)(3 months)
  • Temptation to engage in health risk behaviors (alcohol, smoking, HIV)(3 months)
  • Psychological distress and symptoms(3 months)
  • Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Danielle Parrish

Assistant Professor

University of Houston

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