Intimate Partner ViolencePhase 2NCT00539812
Brief Intervention to Reduce Drinking and Intimate Partner Violence in Women
A Phase 2 study of Intimate Partner Violence and Substance Use, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The purpose of this study is to examine whether adding a brief alcohol treatment to standard violence intervention programs for women will result in reduced drinking, reduced partner violence perpetration, and reduced partner violence victimization. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Intimate Partner Violence, Substance Use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2013
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hazardous drinking
- Participation in a batterer intervention program
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Butler Hospital & University of Tennessee-Knoxville
Providence, Rhode Island, 02906
Gregory L Stuart, PhD
About this study
The purpose of this study is to examine whether adding a brief alcohol treatment to standard violence intervention programs for women will result in reduced drinking, reduced partner violence perpetration, and reduced partner violence victimization. We hypothesize that, relative to standard care, women receiving the additional brief alcohol intervention will have better alcohol use and partner violence outcomes.
- Conditions
- Intimate Partner Violence, Substance Use
- Being tested
- Standard Care, Brief Alcohol Intervention combined with standard care
- Keywords
- Intimate partner violence, alcohol use, substance use
- Medical subject headings
- Substance-Related Disorders, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Standard 40 hour state mandated batterer intervention program
Brief Alcohol Intervention combined with standard careBehavioural
Brief alcohol intervention combined with standard 40 hour state mandated batterer intervention program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard Care only (standard batterer intervention program) Receives: Behavioral: Standard Care |
| 2 | Other | Brief alcohol intervention combined with standard care Receives: Behavioral: Brief Alcohol Intervention combined with standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use and intimate partner violence
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Butler Hospital
- Responsible party
- Sponsor
- Investigators
- Gregory L Stuart, PhD, Principal investigator, University of Tennessee-Knoxville & Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539812
- Sponsor's protocol ID
- NIAAA-STU_016315__0111-001
- Other IDs
- R01AA016315
- Status last verified
- Dec 2012
- First submitted
- 24 Sep 2007
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Reduce Drinking and Intimate Partner Violence in Women
- ClinicalTrials.gov ID
- NCT00539812
- Acronym / sponsor ID
- NIAAA-STU_016315__0111-001
- Conditions
- Intimate Partner Violence, Substance Use
- Keywords
- Intimate partner violence, alcohol use, substance use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Butler Hospital
- Study start
- May 2007
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 5 Oct 2007 (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.
The purpose of this study is to examine whether adding a brief alcohol treatment to standard violence intervention programs for women will result in reduced drinking, reduced partner violence perpetration, and reduced partner violence victimization. We hypothesize that, relative to standard care, women receiving the additional brief alcohol intervention will have better alcohol use and partner violence outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Standard CareStandard Care only (standard batterer intervention program) |
| 2 | Other | Behavioral: Brief Alcohol Intervention combined with standard careBrief alcohol intervention combined with standard care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hazardous drinking
- Participation in a batterer intervention program
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard CareStandard 40 hour state mandated batterer intervention program | Behavioural | 1 |
| Brief Alcohol Intervention combined with standard careBrief alcohol intervention combined with standard 40 hour state mandated batterer intervention program | Behavioural | 2 |
Primary outcome
Substance use and intimate partner violence
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
Related trials for Intimate Partner Violence
Not yet recruiting
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
Alcohol Problems, Post-Traumatic Stress Disorder
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
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.
Gregory L Stuart, PhD principal investigator
University of Tennessee-Knoxville & Butler Hospital
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 of Intimate Partner Violence and Substance Use, run by The University of Tennessee, Knoxville 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Dec 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregory L Stuart, Ph.D. (865-974-3358, gstuart@utk.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use and intimate partner violence (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2012.