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Efficacy Trial of Raices Nuevas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527241
First Posted: September 10, 2007
Last Update Posted: February 10, 2012
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.
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
  Purpose
This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.

Condition Intervention Phase
Intimate Partner Violence Behavioral: Raices nuevas Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy Trial of Raices Nuevas

Further study details as provided by Joanne Klevens, Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Perpetration of violence towards intimate partner [ Time Frame: 3 and 6 months after completion of intervention ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 160
Study Start Date: November 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: A 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.
No Intervention: 2 B
wait-listed for intervention to begin in 6 months

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT00527241


Locations
United States, Michigan
Community Health and Social Services Center (CHASS)
Detroit, Michigan, United States
Sponsors and Collaborators
Joanne Klevens
University of Michigan
The Community Health and Social Services Center, Inc.
  More Information

Responsible Party: Joanne Klevens, epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00527241     History of Changes
Other Study ID Numbers: U49CE000508 ( U.S. NIH Grant/Contract )
IRB #4939
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Joanne Klevens, Centers for Disease Control and Prevention:
partner violence, spouse abuse