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).

Study Overview

• Status: Completed
• Conditions: Smoking; HIV; Contraception; Alcohol Use
• Intervention / Treatment: Behavioral: Choices-Teen

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of alcohol-exposed pregnancy	Timeline Followback Interview	3 months
Risk of nicotine-exposed pregnancy	Timeline Followback Interview	3 months
HIV risk	Timeline Followback Interview	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Danielle E Parrish, Ph.D., University of Houston

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: September 20, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 30, 2014

Study Record Updates

• Last Update Posted (Estimate): September 30, 2014
• Last Update Submitted That Met QC Criteria: September 25, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: HIV; pregnancy; alcohol-exposed pregnancy; nicotine-exposed pregnancy; tobacco-exposed pregnancy; alcohol; contraception; smoking; prevention
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 1R03DA034099-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No