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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252471
• Other study ID #: 1R03DA034099-01
• Status: Completed
• Phase: N/A
• First received: September 20, 2014
• Last updated: September 25, 2014
• Start date: July 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 17 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Use
• Contraception
• HIV
• Smoking

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of alcohol-exposed pregnancy	Timeline Followback Interview	3 months	No
Primary	Risk of nicotine-exposed pregnancy	Timeline Followback Interview	3 months	No
Primary	HIV risk	Timeline Followback Interview	3 months	No
Secondary	Excessive alcohol consumption	AUDIT Scale	3 months	No
Secondary	Psychological distress and symptoms	Brief Symptom Inventory -18	3 months	No
Secondary	Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV)	Decisional Balance Scale	3 months	No
Secondary	Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV)	Processes of Change Questionnaire	3 months	No
Secondary	Temptation to engage in health risk behaviors (alcohol, smoking, HIV)	Temptation Scale	3 months	No
Secondary	Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV)	Confidence Scale	3 months	No