Affect Management for Early Adolescents

This study has been completed.
Information provided by (Responsible Party):
Rhode Island Hospital Identifier:
First received: September 7, 2010
Last updated: March 2, 2016
Last verified: March 2016
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.

Condition Intervention Phase
HIV Infections
Behavioral: Affect Management
Behavioral: General Health Promotion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Affect Management Intervention for Early Adolescents With Mental Health Problems

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Adolescent-reported sexual activity [ Time Frame: 30 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adolescent-reported condom use [ Time Frame: 30 Months ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: August 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: General Health Promotion Behavioral: General Health Promotion
12-session group intervention including health information on a variety of developmentally relevant health topics.
Experimental: Affect Management Behavioral: Affect Management
12-session group intervention including affect management training as well as sexual health skills training.


Ages Eligible for Study:   12 Years to 14 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01197404

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States
Sponsors and Collaborators
Rhode Island Hospital
Principal Investigator: Christopher D Houck, PhD Rhode Island Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rhode Island Hospital Identifier: NCT01197404     History of Changes
Other Study ID Numbers: R01NR011906 
Study First Received: September 7, 2010
Last Updated: March 2, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
HIV Prevention processed this record on May 25, 2016