NCT01207258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

5.1 years

First QC Date

September 21, 2010

Last Update Submit

August 18, 2016

Conditions

Keywords

Motivational InterviewingBrief InterventionIntimate Partner ViolenceDomestic ViolenceAlcohol Abuse

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of brief intervention for decreasing problem drinking and partner violence

    Weekly for 3 months; then 6 and 12 months

Secondary Outcomes (1)

  • Assess impact of brief motivational intervention on IPV severity, alcohol quantity/frequency, self-rated health, health behaviors, quality of life, and relationship satisfaction

    3, 6, and 12 months.

Study Arms (3)

Brief Intervention Group

EXPERIMENTAL

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

Assessed Control Group

NO INTERVENTION

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

No Contact Control Group

NO INTERVENTION

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

Interventions

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.

Brief Intervention Group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department, Hospital of the University of PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

  • 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.

    PMID: 24742322BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Karin V Rhodes, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2010

First Posted

September 22, 2010

Study Start

September 1, 2010

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations