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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00741975
First received: August 25, 2008
Last updated: April 12, 2012
Last verified: February 2012

August 25, 2008
April 12, 2012
April 2007
May 2010   (final data collection date for primary outcome measure)
Adolescent-reported sexual activity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00741975 on ClinicalTrials.gov Archive Site
Adolescent-reported condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
12 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00741975
R34 MH 78750, R34 MH 78750
No
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