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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adolescent-reported condom use [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00741975

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

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00741975     History of Changes
Other Study ID Numbers: R34 MH 78750, R34 MH 78750
Study First Received: August 25, 2008
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV prevention

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014