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NCT00527241 Clinical Trial

Efficacy Trial of Raices Nuevas

Intimate Partner Violence Clinical Trial

Official title:
Efficacy Trial of Raices Nuevas

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00527241
Other study ID # U49CE000508
Secondary ID IRB #4939
Status Completed
Phase Phase 2/Phase 3
First received September 6, 2007
Last updated February 8, 2012
Start date November 2006
Est. completion date June 2009

Study information
Verified date February 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: University of Michigan
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Community Health and Social Services Center (CHASS) Detroit Michigan

Sponsors (3)
Lead Sponsor Collaborator
Joanne Klevens The Community Health and Social Services Center, Inc., University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perpetration of violence towards intimate partner 3 and 6 months after completion of intervention No
Secondary intentions to abuse intimate partner 3 and 6 months after completion of intervention No
Secondary Beliefs, norms, and perceived self-efficacy 3 and 6 months after completion of intervention No
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