Brief Intervention to Reduce Drinking and Intimate Partne... | NCT00539812

Studies
Brief Intervention to Reduce Drinking and Intimate Partner Violence in Women

NCT00539812

Sponsor

The University of Tennessee, Knoxville

Status

Unknown status

Last Update Posted

Dec 18, 2012Estimated

Enrollment

225Estimated

Phase

Phase 2

Conditions

Intimate Partner Violence
Substance Use

Interventions

Standard Care
Brief Alcohol Intervention combined with standard care

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
R01AA016315	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Sep 24, 2007

First Submission Date that Met QC Criteria

Oct 4, 2007

First Posted Date

Oct 5, 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

Dec 17, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH
Butler Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to examine whether adding a brief alcohol treatment to standard violence intervention programs for women will result in reduced drinking, reduced partner violence perpetration, and reduced partner violence victimization. We hypothesize that, relative to standard care, women receiving the additional brief alcohol intervention will have better alcohol use and partner violence outcomes.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	Standard Care only (standard batterer intervention program)	Behavioral: Standard Care
2	Other	Brief alcohol intervention combined with standard care	Behavioral: Brief Alcohol Intervention combined with standard care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard Care	Behavioral	Standard 40 hour state mandated batterer intervention program	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Substance use and intimate partner violence		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hazardous drinking
Participation in a batterer intervention program

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gregory L Stuart, Ph.D.	Contact	865-974-3358		gstuart@utk.edu

Overall Officials

Name	Affiliation	Role
Gregory L Stuart, PhD	University of Tennessee-Knoxville & Butler Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Butler Hospital & University of Tennessee-Knoxville	Recruiting	Providence	Rhode Island	02906	United States

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D000428	Alcohol Drinking

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D004327	Drinking Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care
D000431	Ethanol

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided