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Affect Management for Early Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01197404
First received: September 7, 2010
Last updated: November 3, 2014
Last verified: November 2014
History of Changes
  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 2

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:

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Adolescent-reported sexual activity [ Time Frame: 30 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adolescent-reported condom use [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
Estimated Enrollment: 432
Study Start Date: August 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: General Health Promotion Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics.
Experimental: Affect Management Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training.

  Eligibility
Ages Eligible for Study:   12 Years to 14 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 is 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: NCT01197404

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

No publications provided by Rhode Island Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01197404     History of Changes
Other Study ID Numbers: NR011906, R34 MH 78750
Study First Received: September 7, 2010
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV Prevention

ClinicalTrials.gov processed this record on March 01, 2015