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Brief Intervention for Problem Drinking and Partner Violence

Primary Purpose

Domestic Violence, Alcohol Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Domestic Violence focused on measuring Motivational Interviewing, Brief Intervention, Intimate Partner Violence, Domestic Violence, Alcohol Abuse

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Emergency Department, Hospital of the University of PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Brief Intervention Group

Assessed Control Group

No Contact Control Group

Arm Description

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.

This group does not receive the intervention and is assessed at baseline, weekly for 12 weeks, and at 3, 6 and 12 months.

This group does not receive the intervention and is assessed only at 3 months.

Outcomes

Primary Outcome Measures

Effectiveness of brief intervention for decreasing problem drinking and partner violence

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

Full Information

First Posted
September 21, 2010
Last Updated
August 18, 2016
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01207258
Brief Title
Brief Intervention for Problem Drinking and Partner Violence
Official Title
A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Domestic Violence, Alcohol Abuse
Keywords
Motivational Interviewing, Brief Intervention, Intimate Partner Violence, Domestic Violence, Alcohol Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessed Control Group
Arm Type
No Intervention
Arm Description
This group does not receive the intervention and is assessed at baseline, weekly for 12 weeks, and at 3, 6 and 12 months.
Arm Title
No Contact Control Group
Arm Type
No Intervention
Arm Description
This group does not receive the intervention and is assessed only at 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of brief intervention for decreasing problem drinking and partner violence
Time Frame
Weekly for 3 months; then 6 and 12 months
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin V Rhodes, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Department, Hospital of the University of PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24742322
Citation
Rhodes KV, Rodgers M, Sommers M, Hanlon A, Crits-Christoph P. The Social Health Intervention Project (SHIP): protocol for a randomized controlled clinical trial assessing the effectiveness of a brief motivational intervention for problem drinking and intimate partner violence in an urban emergency department. BMC Emerg Med. 2014 Apr 18;14:10. doi: 10.1186/1471-227X-14-10.
Results Reference
background
PubMed Identifier
32608505
Citation
Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
Results Reference
derived
PubMed Identifier
26241598
Citation
Rhodes KV, Rodgers M, Sommers M, Hanlon A, Chittams J, Doyle A, Datner E, Crits-Christoph P. Brief Motivational Intervention for Intimate Partner Violence and Heavy Drinking in the Emergency Department: A Randomized Clinical Trial. JAMA. 2015 Aug 4;314(5):466-477. doi: 10.1001/jama.2015.8369. Erratum In: JAMA. 2017 Sep 26;318(12 ):1188.
Results Reference
derived

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Brief Intervention for Problem Drinking and Partner Violence

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