This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

Condition Intervention Phase
HIV Infections Behavioral: Affect Management Behavioral: General Health Promotion Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Affect Management Intervention for Early Adolescents With Mental Health Problems

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Adolescent-reported sexual activity [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Adolescent-reported condom use [ Time Frame: 1 year ]

Enrollment: 138
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Affect Management
Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training
Active Comparator: 2
General Health Promotion
Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics


Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00741975

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Principal Investigator: Christopher D Houck, Phd Rhode Island Hospital
  More Information

Responsible Party: Rhode Island Hospital Identifier: NCT00741975     History of Changes
Other Study ID Numbers: R34MH078750 ( U.S. NIH Grant/Contract )
Study First Received: August 25, 2008
Last Updated: April 12, 2012

Keywords provided by Rhode Island Hospital:
HIV prevention

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 19, 2017