- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527241
Efficacy Trial of Raices Nuevas
February 8, 2012 updated by: Joanne Klevens
This trial will test the impact of a culturally tailored and theory driven primary intimate partner violence prevention intervention with Spanish speaking Latino men.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States
- Community Health and Social Services Center (CHASS)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1: A
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perpetration of violence towards intimate partner
Time Frame: 3 and 6 months after completion of intervention
|
3 and 6 months after completion of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intentions to abuse intimate partner
Time Frame: 3 and 6 months after completion of intervention
|
3 and 6 months after completion of intervention
|
Beliefs, norms, and perceived self-efficacy
Time Frame: 3 and 6 months after completion of intervention
|
3 and 6 months after completion of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Estimate)
February 10, 2012
Last Update Submitted That Met QC Criteria
February 8, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U49CE000508 (U.S. NIH Grant/Contract)
- IRB #4939
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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