Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02252471
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Danielle Parrish, University of Houston

Tracking Information
First Submitted Date  ICMJE September 20, 2014
First Posted Date  ICMJE September 30, 2014
Last Update Posted Date September 30, 2014
Study Start Date  ICMJE July 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Risk of alcohol-exposed pregnancy [ Time Frame: 3 months ]
    Timeline Followback Interview
  • Risk of nicotine-exposed pregnancy [ Time Frame: 3 months ]
    Timeline Followback Interview
  • HIV risk [ Time Frame: 3 months ]
    Timeline Followback Interview
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Excessive alcohol consumption [ Time Frame: 3 months ]
    AUDIT Scale
  • Psychological distress and symptoms [ Time Frame: 3 months ]
    Brief Symptom Inventory -18
  • Pros and cons of engaging in health risk behaviors (alcohol, smoking, HIV) [ Time Frame: 3 months ]
    Decisional Balance Scale
  • Experiential and behavioral processes of change for health risk behaviors (alcohol, smoking, HIV) [ Time Frame: 3 months ]
    Processes of Change Questionnaire
  • Temptation to engage in health risk behaviors (alcohol, smoking, HIV) [ Time Frame: 3 months ]
    Temptation Scale
  • Confidence/self-efficacy to not engage in health risk behaviors (alcohol, smoking, HIV) [ Time Frame: 3 months ]
    Confidence Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
Official Title  ICMJE Choices-Teen: A Bundled Risk Reduction Intervention for Juvenile Justice Females
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Use
  • Smoking
  • Contraception
  • HIV
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Choices-Teen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2014)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02252471
Other Study ID Numbers  ICMJE 1R03DA034099-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Danielle Parrish, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE The University of Texas Health Science Center, Houston
Investigators  ICMJE
Principal Investigator: Danielle E Parrish, Ph.D. University of Houston
PRS Account University of Houston
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP