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NCT00603369 Clinical Trial

HIV, Abuse, and Psychiatric Disorders Among Youth

HIV Infections Clinical Trial

— Project STAR  

Official title:
HIV, Abuse, and Psychiatric Disorders Among Youth

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00603369
Other study ID # R01MH061149
Secondary ID R01MH061149
Status Completed
Phase Phase 1
First received January 16, 2008
Last updated February 5, 2009
Start date September 1999
Est. completion date December 2007

Study information
Verified date February 2009
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 212
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 19 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• group intervention
13-session intervention
• group intervention
2-session intervention

Locations
Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary condom use 1 year No
Secondary scores on HIV knowledge questionnaire 1 year No
Secondary number of sexual partners 1 year No
Secondary scores on measure of attitudes toward condom use 1 year No
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