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Brief Intervention for Problem Drinking and Partner Violence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207258
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Domestic Violence Alcohol Abuse Behavioral: Motivational Enhancement Therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Study Start Date : September 2010
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Brief Intervention Group
Participants randomly assigned to this group receive a brief motivational enhancement therapy intervention group and are assessed at baseline, weekly for 12 weeks, and at 3, 6 and 12 months.
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.

No Intervention: Assessed Control Group
This group does not receive the intervention and is assessed at baseline, weekly for 12 weeks, and at 3, 6 and 12 months.
No Intervention: No Contact Control Group
This group does not receive the intervention and is assessed only at 3 months.

Primary Outcome Measures :
  1. Effectiveness of brief intervention for decreasing problem drinking and partner violence [ Time Frame: Weekly for 3 months; then 6 and 12 months ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01207258

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United States, Pennsylvania
Emergency Department, Hospital of the University of PA
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Karin V Rhodes, MD University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pennsylvania Identifier: NCT01207258    
Other Study ID Numbers: R01AA018705-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
Motivational Interviewing
Brief Intervention
Intimate Partner Violence
Domestic Violence
Alcohol Abuse
Additional relevant MeSH terms:
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Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders