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OpenTrials
Completed

NCT Number: NCT01197404

Affect Management for Early Adolescents

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–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rhode Island Hospital

Providence, Rhode Island, 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 is 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: 30 Months

Secondary outcomes

  1. Adolescent-reported condom use

    Time frame: 30 Months

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Registry information

Official study title

Affect Management Intervention for Early Adolescents With Mental Health Problems

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2010
Registry last updated
Mar 3, 2016

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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