Brief Intervention for Problem Drinking and Partner Violence
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|ClinicalTrials.gov Identifier: NCT01207258|
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : August 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Domestic Violence Alcohol Abuse||Behavioral: Motivational Enhancement Therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- Effectiveness of brief intervention for decreasing problem drinking and partner violence [ Time Frame: Weekly for 3 months; then 6 and 12 months ]
- 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. ]
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 ClinicalTrials.gov identifier (NCT number): NCT01207258
|United States, Pennsylvania|
|Emergency Department, Hospital of the University of PA|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Karin V Rhodes, MD||University of Pennsylvania|