Affect Management Intervention for Early Adolescents Wtih Mental Health Problems (Project TRAC)

April 12, 2012 updated by: Rhode Island Hospital

Affect Management Intervention for Early Adolescents With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Affect Management
Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training
Active Comparator: 2
General Health Promotion
Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adolescent-reported sexual activity
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adolescent-reported condom use
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

  • Principal Investigator: Christopher D Houck, PhD, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2012

Last Update Submitted That Met QC Criteria

April 12, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH078750 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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