Affect Management for Early Adolescents

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rhode Island Hospital

ClinicalTrials.gov Identifier:

NCT01197404

First received: September 7, 2010

Last updated: March 2, 2016

Last verified: March 2016

History of Changes

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 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:

MedlinePlus related topics: HIV/AIDS Mental Health

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	12 Years to 14 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

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

ClinicalTrials.gov processed this record on September 27, 2016

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