NCT01197404

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
420

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_2 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

August 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

5.3 years

First QC Date

September 7, 2010

Last Update Submit

March 2, 2016

Conditions

Keywords

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • Adolescent-reported sexual activity

    30 Months

Secondary Outcomes (1)

  • Adolescent-reported condom use

    30 Months

Study Arms (2)

General Health Promotion

ACTIVE COMPARATOR
Behavioral: General Health Promotion

Affect Management

EXPERIMENTAL
Behavioral: Affect Management

Interventions

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

Affect Management

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

General Health Promotion

Eligibility Criteria

Age12 Years - 14 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 is 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, United States

Location

Related Publications (3)

  • Houck CD, Hadley W, Barker D, Brown LK, Hancock E, Almy B. An Emotion Regulation Intervention to Reduce Risk Behaviors Among at-Risk Early Adolescents. Prev Sci. 2016 Jan;17(1):71-82. doi: 10.1007/s11121-015-0597-0.

  • Houck CD, Barker DH, Hadley W, Menefee M, Brown LK. Sexual Risk Outcomes of an Emotion Regulation Intervention for At-Risk Early Adolescents. Pediatrics. 2018 Jun;141(6):e20172525. doi: 10.1542/peds.2017-2525. Epub 2018 May 10.

  • Houck CD, Barker D, Rizzo C, Hancock E, Norton A, Brown LK. Sexting and sexual behavior in at-risk adolescents. Pediatrics. 2014 Feb;133(2):e276-82. doi: 10.1542/peds.2013-1157. Epub 2014 Jan 6.

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

August 1, 2009

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations