Back to resultsHIV, Abuse, and Psychiatric Disorders Among Youth (Project STAR)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
group intervention
group intervention
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:
- Adolescent attending therapeutic school
Exclusion Criteria:
- Adolescent is HIV positive
- Adolescent is developmentally delayed
- Adolescent is 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
13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.
2 session group intervention including sexual health information training.
Outcomes
Primary Outcome Measures
condom use
Secondary Outcome Measures
scores on HIV knowledge questionnaire
number of sexual partners
scores on measure of attitudes toward condom use
Full Information
NCT ID
NCT00603369
First Posted
January 16, 2008
Last Updated
February 5, 2009
Sponsor
Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00603369
Brief Title
HIV, Abuse, and Psychiatric Disorders Among Youth
Acronym
Project STAR
Official Title
HIV, Abuse, and Psychiatric Disorders Among Youth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
One subgroup of adolescents at particular risk for HIV is those with psychiatric disorders. Furthermore, those with histories of sexual abuse have been found to have riskier attitudes, poorer sexual communication skills, and less consistent condom use than non-abused peers. This study implemented and evaluated interventions for adolescents in intensive psychiatric treatment settings, particularly those with histories of sexual abuse. It is hypothesized that those participating in the intervention that addresses affect management and cognitive monitoring strategies will show fewer HIV-risk related behaviors and attitudes at posttest than peers in an information-based intervention.
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
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
13 session group intervention including sexual health information, affect management skills, cognitive monitoring, and communication skills training.
Arm Title
2
Arm Type
Active Comparator
Arm Description
2 session group intervention including sexual health information training.
Intervention Type
Behavioral
Intervention Name(s)
group intervention
Intervention Description
13-session intervention
Intervention Type
Behavioral
Intervention Name(s)
group intervention
Intervention Description
2-session intervention
Primary Outcome Measure Information:
Title
condom use
Time Frame
1 year
Secondary Outcome Measure Information:
Title
scores on HIV knowledge questionnaire
Time Frame
1 year
Title
number of sexual partners
Time Frame
1 year
Title
scores on measure of attitudes toward condom use
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adolescent attending therapeutic school
Exclusion Criteria:
Adolescent is HIV positive
Adolescent is developmentally delayed
Adolescent is pregnant
Adolescent has a 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
Citations:
PubMed Identifier
21961780
Citation
Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27.
Results Reference
derived
Learn more about this trial
HIV, Abuse, and Psychiatric Disorders Among Youth
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