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Clinical Trials/NCT01197404
NCT01197404CompletedPhase 2

Affect Management Intervention for Early Adolescents With Mental Health Problems

Rhode Island Hospital1 site in 1 country420 target enrollmentStarted: August 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
420
Locations
1
Primary Endpoint
Adolescent-reported sexual activity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
12 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Adolescent-reported sexual activity

Time Frame: 30 Months

Secondary Outcomes

  • Adolescent-reported condom use(30 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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