Clinical trial NCT02252471: Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
Official title: Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use
Smoking
Contraception
HIV
Keywords: alcohol-exposed pregnancy
nicotine-exposed pregnancy
tobacco-exposed pregnancy
alcohol
contraception
smoking
pregnancy
HIV
prevention
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2014-09-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Risk of alcohol-exposed pregnancy
timeFrame: 3 months
measure: Risk of nicotine-exposed pregnancy
timeFrame: 3 months
measure: HIV risk
timeFrame: 3 months
Secondary outcomes:
measure: Excessive alcohol consumption
timeFrame: 3 months
measure: Psychological distress and symptoms
timeFrame: 3 months
measure: Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)
timeFrame: 3 months
measure: Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)
timeFrame: 3 months
measure: Temptation to engage in health risk behaviors (alcohol, smoking, HIV)
timeFrame: 3 months
measure: Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Houston
name: Danielle E Parrish, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: