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Affect Management for Early Adolescents

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01197404

First Posted: September 9, 2010

Last Update Posted: March 3, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Rhode Island Hospital

Purpose

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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Affect Management Intervention for Early Adolescents With Mental Health Problems

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:

Adolescent-reported sexual activity [ Time Frame: 30 Months ]

Secondary Outcome Measures:

Adolescent-reported condom use [ Time Frame: 30 Months ]


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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 14 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197404

Locations


United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States

Sponsors and Collaborators

Rhode Island Hospital

Investigators


Principal Investigator:	Christopher D Houck, PhD	Rhode Island Hospital

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT01197404 History of Changes
Other Study ID Numbers:	R01NR011906 ( U.S. NIH Grant/Contract )
First Submitted:	September 7, 2010
First Posted:	September 9, 2010
Last Update Posted:	March 3, 2016
Last Verified:	March 2016

Keywords provided by Rhode Island Hospital:


HIV Prevention

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

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