Intimate Partner ViolencePhase 2NCT01753986
Alcohol Use and Relationships - III
A Phase 2 study testing Brief Alcohol Intervention plus Standard Batterer Intervention and General Health Improvement Intervention plus Standard Batterer Intervention in people with Intimate Partner Violence and Substance Use, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
The investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence, Substance Use
- What is being tested?
- Brief Alcohol Intervention plus Standard Batterer Intervention and General Health Improvement Intervention plus Standard Batterer Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in Batterer Intervention Program in RI
- Hazardous Drinking
Who cannot join
- drinks too much
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Butler Hospital
Providence, Rhode Island, 02906
Gregory Stuart, PhD, gstuart@utk.edu
Yael Schonbrun, PhD
About this study
Official title: Impact of Brief Substance Use Intervention on Substance Use and Intimate Partner Violence
The investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention.
- Conditions
- Intimate Partner Violence, Substance Use
- Being tested
- Brief Alcohol Intervention plus Standard Batterer Intervention, General Health Improvement Intervention plus Standard Batterer Intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Alcohol Intervention plus Standard Batterer InterventionBehavioural
Brief Alcohol Intervention plus 40 hours or Standard Batterer Intervention
General Health Improvement Intervention plus Standard Batterer InterventionBehavioural
General Health Improvement Intervention plus 40 hours of Standard Batterer Intervention
| Study group | Role | What they receive |
|---|---|---|
| Brief Alcohol Intervention plus Standard Batterer intervention | Experimental | Brief Alcohol Intervention plus 40 hours of Standard Batterer intervention Receives: Behavioral: Brief Alcohol Intervention plus Standard Batterer Intervention |
| General Health Improvement plus Standard batterer intervention | Placebo comparator | General Health Improvement Intervention plus 40 hours of Standard Batterer intervention Receives: Behavioral: General Health Improvement Intervention plus Standard Batterer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lower levels of intimate partner violence
lower levels of any violence and severe intimate partner violence (psychological, physical, sexual, injuries)
Measured: one year
Secondary outcomes (1)
lower levels of substance use (alcohol and drug)
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 posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753986
- Sponsor's protocol ID
- 1210-005
- Status last verified
- Dec 2012
- First submitted
- 17 Dec 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Brief Substance Use Intervention on Substance Use and Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT01753986
- Acronym / sponsor ID
- 1210-005
- Conditions
- Intimate Partner Violence, Substance Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Dec 2012 (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 investigators hypothesize that individuals receiving the brief substance use intervention will have better substance use and intimate partner violence outcomes than individuals receiving the general health improvement intervention. All participants receive standard batterer intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Alcohol Intervention plus Standard Batterer intervention | Experimental | Behavioral: Brief Alcohol Intervention plus Standard Batterer InterventionBrief Alcohol Intervention plus 40 hours of Standard Batterer intervention |
| General Health Improvement plus Standard batterer intervention | Placebo comparator | Behavioral: General Health Improvement Intervention plus Standard Batterer InterventionGeneral Health Improvement Intervention plus 40 hours of Standard Batterer intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in Batterer Intervention Program in RI
- Hazardous Drinking
Key exclusion criteria (1 listed)
- drinks too much
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 |
|---|---|---|
| Brief Alcohol Intervention plus Standard Batterer InterventionBrief Alcohol Intervention plus 40 hours or Standard Batterer Intervention | Behavioural | Brief Alcohol Intervention plus Standard Batterer intervention |
| General Health Improvement Intervention plus Standard Batterer InterventionGeneral Health Improvement Intervention plus 40 hours of Standard Batterer Intervention | Behavioural | General Health Improvement plus Standard batterer intervention |
Primary outcome
lower levels of intimate partner violence
Time frame: one year
lower levels of any violence and severe intimate partner violence (psychological, physical, sexual, injuries)
1 secondary outcome
lower levels of substance use (alcohol and drug)
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 20 Dec 2012.
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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.
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 Brief Alcohol Intervention plus Standard Batterer Intervention and General Health Improvement Intervention plus Standard Batterer Intervention in people with 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 1 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 20 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower levels of 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 20 Dec 2012.