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

Not Applicable

Completed

• Conditions: Alcohol Use; Smoking; Contraception; HIV
• Interventions: Behavioral: Choices-Teen

• Registration Number: NCT02252471
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-09
• Study First Submitted: 2014-09-20
• Study First Submitted QC: 2014-09-25
• Last Update Submitted: 2014-09-25
• Study First Posted: 2014-09-30
• Last Update Posted: 2014-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Choices-Teen Intervention	Choices-Teen	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.

Primary Outcome Measures

Name	Time	Method
HIV risk	3 months	Timeline Followback Interview
Risk of nicotine-exposed pregnancy	3 months	Timeline Followback Interview
Risk of alcohol-exposed pregnancy	3 months	Timeline Followback Interview

Secondary Outcome Measures

Name	Time	Method
Excessive alcohol consumption	3 months	AUDIT Scale
Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)	3 months	Confidence Scale
Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)	3 months	Processes of Change Questionnaire
Temptation to engage in health risk behaviors (alcohol, smoking, HIV)	3 months	Temptation Scale
Psychological distress and symptoms	3 months	Brief Symptom Inventory -18
Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)	3 months	Decisional Balance Scale