Intimate Partner ViolencePhase 2NCT00539955
Brief Intervention to Reduce Drinking Among Batterers
A Phase 2 study testing Standard Batterer Intervention and Brief Alcohol Intervention in people with Intimate Partner Violence and Alcohol Use, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The goal of this project is to examine whether, relative to standard care, violence and alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol treatment for men enrolled in batterer intervention programs. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Intimate Partner Violence, Alcohol Use
- What is being tested?
- Standard Batterer Intervention and Brief Alcohol Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Dec 2012
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in a batterer intervention program
- Hazardous drinking
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to examine whether, relative to standard care, violence and alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol treatment for men enrolled in batterer intervention programs. We hypothesize that men randomized to also receive the brief alcohol intervention will have better partner violence and alcohol use outcomes than men who are randomized to the batterer intervention program alone.
- Conditions
- Intimate Partner Violence, Alcohol Use
- Being tested
- Standard Batterer Intervention, Brief Alcohol Intervention
- Keywords
- intimate partner violence, alcohol use, substance use
- Medical subject headings
- Alcohol Drinking, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Batterer InterventionBehavioural
Standard state-mandated batterer intervention program (40 hours)
Brief Alcohol InterventionBehavioural
Brief alcohol intervention combined with state mandated batterer intervention program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Standard 40 hour state-mandated batterer intervention Receives: Behavioral: Standard Batterer Intervention |
| 2 | Other | Brief alcohol intervention combined with standard batterer intervention Receives: Behavioral: Brief Alcohol Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intimate partner violence Substance use
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 startJul 2003
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 253 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 HospitalDavid Strong, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539955
- Sponsor's protocol ID
- NIAAA-STU_014193_0111-001-M
- Other IDs
- R01AA014193
- Status last verified
- Dec 2012
- First submitted
- 25 Sep 2007
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stuart GL, McGeary J, Shorey RC, Knopik VS. Genetics moderate alcohol and intimate partner violence treatment outcomes in a randomized controlled trial of hazardous drinking men in batterer intervention programs: A preliminary investigation. J Consult Clin Psychol. 2016 Jul;84(7):592-8. doi: 10.1037/a0040219. Epub 2016 Mar 28.
PubMed 27018532
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 Among Batterers
- ClinicalTrials.gov ID
- NCT00539955
- Acronym / sponsor ID
- NIAAA-STU_014193_0111-001-M
- Conditions
- Intimate Partner Violence, Alcohol Use
- Keywords
- intimate partner violence, alcohol use, substance use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 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
- Jul 2003
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (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 goal of this project is to examine whether, relative to standard care, violence and alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol treatment for men enrolled in batterer intervention programs. We hypothesize that men randomized to also receive the brief alcohol intervention will have better partner violence and alcohol use outcomes than men who are randomized to the batterer intervention program alone.
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 Batterer InterventionStandard 40 hour state-mandated batterer intervention |
| 2 | Other | Behavioral: Brief Alcohol InterventionBrief alcohol intervention combined with standard batterer intervention |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in a batterer intervention program
- Hazardous drinking
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 Batterer InterventionStandard state-mandated batterer intervention program (40 hours) | Behavioural | 1 |
| Brief Alcohol InterventionBrief alcohol intervention combined with state mandated batterer intervention program | Behavioural | 2 |
Primary outcome
Intimate partner violence Substance use
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.
- Derived from this study: PubMed 27018532Stuart GL, McGeary J, Shorey RC, Knopik VS. Genetics moderate alcohol and intimate partner violence treatment outcomes in a randomized controlled trial of hazardous drinking men in batterer intervention programs: A preliminary investigation. J Consult Clin Psychol. 2016 Jul;84(7):592-8. doi: 10.1037/a0040219. Epub 2016 Mar 28.
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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.
Gregory L. Stuart, PhD principal investigator
University of Tennessee-Knoxville & Butler Hospital
David Strong, PhD principal investigator
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 testing Standard Batterer Intervention and Brief Alcohol Intervention in people with Intimate Partner Violence and Alcohol 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?
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?
Intimate partner violence Substance use (time frame: one year). 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 NCT00539955, which also lists 1 linked publication.
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.