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NCT00500487 Clinical Trial

Therapeutic Schools: Affect Management and HIV Prevention

HIV Infections Clinical Trial

Official title:
Therapeutic Schools: Affect Management and HIV Prevention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500487
Other study ID # R01MH066641
Secondary ID R01MH066641
Status Completed
Phase Phase 1
First received July 11, 2007
Last updated January 9, 2015
Start date April 2003
Est. completion date June 2010

Study information
Verified date October 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

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.

Recruitment information / eligibility
Status Completed
Enrollment 420
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 18 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:
• Affect Management
12-session group intervention including affect management training as well as sexual health skills training.
• HIV Prevention Skills
12-session group intervention including sexual health skills training.
• General Health Promotion
12-session group intervention including health information on a variety of health topics.

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

Sponsors (2)
Lead Sponsor Collaborator
Rhode Island Hospital University of Chicago

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adolescent-reported condom use 1 year No
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