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Brief Intervention for Problem Drinking and Partner Violence

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Karin Rhodes, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01207258
First received: September 21, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

This study is a randomized controlled trial of a brief intervention for women Emergency Department patients with involvement in both Intimate Partner Violence (IPV) and problem drinking (defined as the full spectrum of hazardous, harmful, or dependent drinking). The study is designed to explore the effectiveness of a low-intensity, gender-sensitive brief motivational intervention, delivered by social workers in the Emergency Department setting, in decreasing IPV and episodes of heavy drinking and increasing rates of follow-up with resources. Social work graduate students and/or staff will be trained to provide brief motivational enhancement therapy (MET) intervention for decreasing heavy drinking and IPV-related injury in women Emergency Department patients.


Condition Intervention Phase
Domestic Violence
Alcohol Abuse
Behavioral: Motivational Enhancement Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Effectiveness of brief intervention for decreasing problem drinking and partner violence [ Time Frame: Weekly for 3 months; then 6 and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess impact of brief motivational intervention on IPV severity, alcohol quantity/frequency, self-rated health, health behaviors, quality of life, and relationship satisfaction [ Time Frame: 3, 6, and 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief intervention Behavioral: Motivational Enhancement Therapy
20 minute manual-driven, optionally audio-recorded Motivational Enhancement Training intervention by a MI-trained therapist during their ED visit and a 10-15 minute phone booster at 7 to 10 days.

Detailed Description:

The investigators will enroll a total of 600 eligible consenting women patients who will be randomized to a Brief Intervention Group (BIG) n=240, an Assessed Care Group (ACG) n=240 or to a No Contact Control Group (NCCG) n=120, that is screened for eligibility and provides basic demographic information but has no further contact with researchers until they are assessed for outcomes only at 3 months. All participants will complete an initial Social Health Survey, a form distributed routinely to all patients in the ED which gives patients an opportunity to self-disclose a variety of social and behavioral risks as part of routine care. As part of the study, patients who disclose any IPV or drinking risk will be asked to complete a further screening (CTS2S and AUDIT) to confirm eligibility prior to randomization. The experimental group (BIG) will receive a 20 minute manual driven, optionally audio-recorded MET intervention by a Motivational Interview (MI)-trained therapist during their ED visit and a 10-15 minute phone booster at 7 to 10 days. The BIG and ACG will be assessed at baseline using the Women's Health Interview to identify potential moderators of the intervention and followed weekly for IPV and drinking outcomes using an Interactive Voice Response System (IVRS) for 12 weeks and phone assessments at 3, 6, and 12 months.

Primary outcomes, assessed for all groups at 3 months, will be the number of heavy drinking days and the incidents of IPV in the last month. Secondary outcomes include number of severe IPV incidents and average weekly alcohol consumption. The investigators will also assess likely mediators of the intervention. Protocol for follow-up contact will be determined by a plan developed by the participant and the MET interventionist. Should a participant decide that it is unsafe to be contacted via telephone, she will be given the option to complete any or all follow-up in the ED. Each time the patient is contacted for follow-up, the researcher will ask if the plan for contact has changed and will implement the necessary changes during the subsequent contacts. In addition, participants will be told that they can contact the PI using the contact information provided on the study's consent materials if the plan changes between contacts. Participants will also be asked at each follow-up contact if they are still interested in participating in the Women's Health Study to ensure ongoing consent. They may decide not to continue participation, and do not need to provide a reason for withdrawal from the study.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Registered as an ED patient.
  • Able to participate verbally in an English language interview.
  • Able to participate cognitively in an English language interview.
  • Heavy drinking as assessed by the AUDIT.
  • Positive screen for Intimate Partner Violence in the past 3 months.

Exclusion Criteria:

  • Intoxication at the time of screening.
  • Cognitive impairment or psychosis identified on physical exam or chart review.
  • Serious current medical illness or injury, defined as respiratory distress, hemodynamic instability, active vomiting, bleeding, labor, severe pain, or acute need for hospital admission.
  • Suicidal or homicidal ideation by chart review or on the Danger Assessment Scale for all assessed patients.
  • No identifiable residence or contact phone number.
  • Under arrest at the time of ED visit.
  • Non-English speaking.
  • Previously enrolled in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207258

Contacts
Contact: Karin V Rhodes, MD 215-573-3055 karin.rhodes@uphs.upenn.edu

Locations
United States, Pennsylvania
Emergency Department, Hospital of the University of PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Karin V Rhodes, MD, MS    215-421-1036    kvr@sp2.upenn.edu   
Principal Investigator: Karin V Rhodes, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Karin V Rhodes, MD University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karin Rhodes, Director, Center for Emergency Care Policy & Research, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01207258     History of Changes
Other Study ID Numbers: R01-AA018705-01A1
Study First Received: September 21, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Motivational Interviewing
Brief Intervention
Intimate Partner Violence
Domestic Violence
Alcohol Abuse

ClinicalTrials.gov processed this record on November 27, 2014