Efficacy Trial of Raices Nuevas

This study has been completed.

Sponsor:

Collaborators:

University of Michigan

The Community Health and Social Services Center, Inc.

Information provided by (Responsible Party):

Joanne Klevens, Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00527241

First received: September 6, 2007

Last updated: February 8, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 6, 2007
Last Updated Date	February 8, 2012
Start Date ^ICMJE	November 2006
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2012)	Perpetration of violence towards intimate partner [ Time Frame: 3 and 6 months after completion of intervention ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: September 6, 2007)	Perpetration of violence towards intimate partner [ Time Frame: 3 and 6 months after completion of intervention ]
Change History	Complete list of historical versions of study NCT00527241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 8, 2012)	intentions to abuse intimate partner [ Time Frame: 3 and 6 months after completion of intervention ] [ Designated as safety issue: No ] Beliefs, norms, and perceived self-efficacy [ Time Frame: 3 and 6 months after completion of intervention ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 6, 2007)	intentions to abuse intimate partner [ Time Frame: 3 and 6 months after completion of intervention ] Beliefs, norms, and perceived self-efficacy [ Time Frame: 3 and 6 months after completion of intervention ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy Trial of Raices Nuevas
Official Title ^ICMJE	Efficacy Trial of Raices Nuevas
Brief Summary	This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.
Detailed Description	In this randomized controlled trial, Spanish speaking Latino men will be recruited from community church settings in Southwest Detroit and randomly assigned to: (a) an intimate partner violence prevention intervention or (b) a wait-list control condition. Latino men assigned to the intervention will receive, in a small group setting, an 8-session, primary intimate partner violence prevention intervention based on the Duluth model and culturally and linguistically tailored for Spanish speaking Latino men. Measures will be administered at pre-test, and at three and six months post-intervention.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Intimate Partner Violence
Intervention ^ICMJE	Behavioral: Raices nuevas 8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.
Study Arm (s)	Experimental: 1: A Intervention: Behavioral: Raices nuevas No Intervention: 2 B wait-listed for intervention to begin in 6 months
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	June 2009
Primary Completion Date	June 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Spanish speaking Latino men between the ages of 18 and 55 in a stable relationship for at least the past three months Exclusion Criteria: severely mentally impaired hearing impaired
Gender	Male
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00527241
Other Study ID Numbers ^ICMJE	U49 CE000508, IRB #4939
Has Data Monitoring Committee	No
Responsible Party	Joanne Klevens, Centers for Disease Control and Prevention
Study Sponsor ^ICMJE	Joanne Klevens
Collaborators ^ICMJE	University of Michigan The Community Health and Social Services Center, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Centers for Disease Control and Prevention
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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