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OpenTrials
Completed

NCT Number: NCT00741975

Affect Management Intervention for Early Adolescents Wtih Mental Health Problems

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Affect Management

Behavioral

12-session group intervention including affect management training as well as sexual health skills training

General Health Promotion

Behavioral

12-session group intervention including health information on a variety of developmentally relevant health topics

Primary outcomes

  1. Adolescent-reported sexual activity

    Time frame: 1 year

Secondary outcomes

  1. Adolescent-reported condom use

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Affect Management Intervention for Early Adolescents With Mental Health Problems

Acronym: Project TRAC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2008
Registry last updated
Apr 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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