An Affect Management Intervention for Juvenile Offenders
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Affect Management
General Health Promotion
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention, HIV seronegativity
Eligibility Criteria
Inclusion Criteria:
- Adolescents enrolled in the juvenile drug court program
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is pregnant
- Adolescent is developmentally delayed
- Adolescent has history of sexual crime
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Adolescent-reported sexual activity and condom use
Secondary Outcome Measures
Adolescent substance use (self-report and urine toxicology screen results)
Full Information
NCT ID
NCT00748800
First Posted
September 5, 2008
Last Updated
February 5, 2009
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00748800
Brief Title
An Affect Management Intervention for Juvenile Offenders
Official Title
An Affect Management Intervention for Juvenile Offenders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention, HIV seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Affect Management
Intervention Description
5 session group intervention that focused on teaching affect management skills and included HIV prevention and sexual health training
Intervention Type
Behavioral
Intervention Name(s)
General Health Promotion
Intervention Description
5 session group focused on delivering general health promotion information in didactic format
Primary Outcome Measure Information:
Title
Adolescent-reported sexual activity and condom use
Time Frame
3 month post-intervention
Secondary Outcome Measure Information:
Title
Adolescent substance use (self-report and urine toxicology screen results)
Time Frame
3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adolescents enrolled in the juvenile drug court program
Exclusion Criteria:
Adolescent is HIV positive
Adolescent is pregnant
Adolescent is developmentally delayed
Adolescent has history of sexual crime
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry K Brown, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
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An Affect Management Intervention for Juvenile Offenders
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