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Affect Management for Early Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01197404
First received: September 7, 2010
Last updated: November 3, 2014
Last verified: November 2014

September 7, 2010
November 3, 2014
August 2009
November 2014   (final data collection date for primary outcome measure)
Adolescent-reported sexual activity [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01197404 on ClinicalTrials.gov Archive Site
Adolescent-reported condom use [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Affect Management for Early Adolescents
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Behavioral: Affect Management
    12-session group intervention including affect management training as well as sexual health skills training.
  • Behavioral: General Health Promotion
    12-session group intervention including health information on a variety of developmentally relevant health topics.
  • Active Comparator: General Health Promotion
    Intervention: Behavioral: General Health Promotion
  • Experimental: Affect Management
    Intervention: Behavioral: Affect Management
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
432
November 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
12 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01197404
NR011906, R34 MH 78750
No
Rhode Island Hospital
Rhode Island Hospital
Not Provided
Principal Investigator: Christopher D Houck, PhD Rhode Island Hospital
Rhode Island Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP