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Affect Management Intervention for Early Adolescents Wtih Mental Health Problems (Project TRAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741975
First Posted: August 27, 2008
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rhode Island Hospital
August 25, 2008
August 27, 2008
April 13, 2012
April 2007
May 2010   (Final data collection date for primary outcome measure)
Adolescent-reported sexual activity [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00741975 on ClinicalTrials.gov Archive Site
Adolescent-reported condom use [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Affect Management Intervention for Early Adolescents Wtih Mental Health Problems
Affect Management Intervention for Early Adolescents With Mental Health Problems
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Affect Management
    12-session group intervention including affect management training as well as sexual health skills training
  • Behavioral: General Health Promotion
    12-session group intervention including health information on a variety of developmentally relevant health topics
  • Experimental: 1
    Affect Management
    Intervention: Behavioral: Affect Management
  • Active Comparator: 2
    General Health Promotion
    Intervention: Behavioral: General Health Promotion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
May 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 16 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00741975
R34MH078750( U.S. NIH Grant/Contract )
R34MH078750 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Christopher D Houck, Phd Rhode Island Hospital
Rhode Island Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP