Brief Intervention for Problem Drinking and Partner Violence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 2/7/2015 |
| Start Date: | September 2010 |
| End Date: | September 2014 |
| Contact: | Karin V Rhodes, MD |
| Email: | karin.rhodes@uphs.upenn.edu |
| Phone: | 215-573-3055 |
A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
