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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: March 26, 2013
Last verified: March 2013
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: September 2014
Estimated Primary Completion Date: September 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
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

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: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV Prevention

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

ClinicalTrials.gov processed this record on June 17, 2013