NCT00741975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Apr 2007

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 13, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

August 25, 2008

Last Update Submit

April 12, 2012

Conditions

HIV Infections

Keywords

HIV prevention

Outcome Measures

Primary Outcomes (1)

  • Adolescent-reported sexual activity

    1 year

Secondary Outcomes (1)

  • Adolescent-reported condom use

    1 year

Study Arms (2)

1

EXPERIMENTAL

Affect Management

Behavioral: Affect Management

2

ACTIVE COMPARATOR

General Health Promotion

Behavioral: General Health Promotion

Interventions

Affect ManagementBEHAVIORAL

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

1
General Health PromotionBEHAVIORAL

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

2

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Seventh graders identified by counselors at participating public school

You may not qualify if:

  • Adolescent is HIV positive
  • Adolescent is developmentally delayed
  • Adolescent in pregnant
  • Adolescent has a history of sexual crime

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Christopher D Houck, Phd

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 13, 2012

Record last verified: 2012-02

Locations

US(1)