Domestic ViolencePhase 2NCT01207258
Brief Intervention for Problem Drinking and Partner Violence
A Phase 2 study testing Motivational Enhancement Therapy in people with Domestic Violence and Alcohol Abuse, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Domestic Violence, Alcohol Abuse
- What is being tested?
- Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emergency Department, Hospital of the University of PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Domestic Violence, Alcohol Abuse
- Being tested
- Motivational Enhancement Therapy
- Keywords
- Motivational Interviewing, Brief Intervention, Intimate Partner Violence, Domestic Violence, Alcohol Abuse
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Enhancement TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of brief intervention for decreasing problem drinking and partner violence
Measured: 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
Measured: 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin V Rhodes, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207258
- Sponsor's protocol ID
- R01AA018705-01A1
- Status last verified
- Aug 2016
- First submitted
- 21 Sep 2010
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24742322Hameed 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.
PubMed 32608505Rhodes 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.
PubMed 26241598
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Brief Intervention for Problem Drinking and Partner Violence
- ClinicalTrials.gov ID
- NCT01207258
- Acronym / sponsor ID
- R01AA018705-01A1
- Conditions
- Domestic Violence, Alcohol Abuse
- Keywords
- Motivational Interviewing, Brief Intervention, Intimate Partner Violence, Domestic Violence, Alcohol Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention Group | Experimental | Behavioral: Motivational Enhancement TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Enhancement Therapy20 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. | Behavioural | Brief Intervention Group |
Primary outcome
Effectiveness of brief intervention for decreasing problem drinking and partner violence
Time frame: Weekly for 3 months; then 6 and 12 months
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 24742322Rhodes 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.
- Derived from this study: PubMed 32608505Hameed 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.
- Derived from this study: PubMed 26241598Rhodes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin V Rhodes, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Enhancement Therapy in people with Domestic Violence and Alcohol Abuse, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of brief intervention for decreasing problem drinking and partner violence (time frame: Weekly for 3 months; then 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207258, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.