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Affect Management for Early Adolescents

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.
ClinicalTrials.gov Identifier: NCT01197404
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Behavioral: Affect Management Behavioral: General Health Promotion Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
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
Study Start Date : August 2009
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Adolescent-reported sexual activity [ Time Frame: 30 Months ]

Secondary Outcome Measures :
  1. Adolescent-reported condom use [ Time Frame: 30 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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: R01NR011906 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

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