Efficacy Trial of Raices Nuevas | NCT00527241

Studies
Efficacy Trial of Raices Nuevas

NCT00527241

Sponsor

Joanne Klevens

Status

Completed

Last Update Posted

Feb 10, 2012Estimated

Enrollment

160Actual

Phase

Phase 2Phase 3

Conditions

Intimate Partner Violence

Interventions

Raices nuevas

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB #4939

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Sep 6, 2007

First Submission Date that Met QC Criteria

Sep 6, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2012

Last Update Posted Date

Feb 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joanne Klevens, epidemiologist, Centers for Disease Control and PreventionSponsor-Investigator

Lead Sponsor

Joanne KlevensFED

Collaborators

Name	Class
University of Michigan	OTHER
The Community Health and Social Services Center, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: A	Experimental		Behavioral: Raices nuevas
2 B	No Intervention	wait-listed for intervention to begin in 6 months

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Raices nuevas	Behavioral	8 90-minute sessions (once a week) of problem-posing and facilitated discussion on respect, anger, support, trust, negotiating, partnership with your intimate partner.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perpetration of violence towards intimate partner		3 and 6 months after completion of intervention

Secondary Outcomes

Measure	Description	Time Frame
intentions to abuse intimate partner		3 and 6 months after completion of intervention
Beliefs, norms, and perceived self-efficacy		3 and 6 months after completion of intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Community Health and Social Services Center (CHASS)		Detroit	Michigan		United States