Back to resultsAffect Management Intervention for Early Adolescents Wtih Mental Health Problems (Project TRAC)
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
Eligibility Criteria
Inclusion Criteria:
- Seventh graders identified by counselors at participating public school
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent in pregnant
- Adolescent has a 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
Affect Management
General Health Promotion
Outcomes
Primary Outcome Measures
Adolescent-reported sexual activity
Secondary Outcome Measures
Adolescent-reported condom use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00741975
Brief Title
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
Acronym
Project TRAC
Official Title
Affect Management Intervention for Early Adolescents With Mental Health Problems
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. Problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. This project will develop and evaluate interventions for early adolescents with mental health issues. An intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Affect Management
Arm Title
2
Arm Type
Active Comparator
Arm Description
General Health Promotion
Intervention Type
Behavioral
Intervention Name(s)
Affect Management
Intervention Description
12-session group intervention including affect management training as well as sexual health skills training
Intervention Type
Behavioral
Intervention Name(s)
General Health Promotion
Intervention Description
12-session group intervention including health information on a variety of developmentally relevant health topics
Primary Outcome Measure Information:
Title
Adolescent-reported sexual activity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adolescent-reported condom use
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Seventh graders identified by counselors at participating public school
Exclusion Criteria:
Adolescent is HIV positive
Adolescent is developmentally delayed
Adolescent in pregnant
Adolescent has a history of sexual crime
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Houck, Phd
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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Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
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