Domestic ViolencePhase 1MDACUNCT01621334
The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use
A Phase 1 study testing Motivational Enhancement Therapy and Educational information in people with Domestic Violence and Substance Abuse, run by University of Washington at 1 site in United States.
Trial summary
This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence, Substance Abuse
- What is being tested?
- Motivational Enhancement Therapy and Educational information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 2012
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age (18 years and older)
- gender (male)
- self-reported abusive behaviors
- concerned about alcohol or drug use
Who cannot join
- not fluent in English
- they have a thought disorder that precludes full participation
- they refuse to accept randomization to condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Innovative Programs Research Group, School of Social Work, University of Washington
Seattle, Washington, 98105
About this study
Official title: Stage 1B Study Motivating Substance Abusing Batterers to Seek Treatment.
This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.
Read the detailed description
One hundred and forty adult men concerned about their substance use and behaviors toward intimate partners, recruited in Washington State, will be enrolled in the trial. Participants are recruited through print and radio ads. Following a baseline assessment, participants are then randomly assigned to receive one of two interventions:
- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the counselor employing motivational interviewing strategies intended to impact study outcomes.
- The comparison condition involves an educational brochure focusing on the legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors.
Following the two interventions, participants are reassessed at 1 week, 1 month, and 4 months following either intervention.
- Conditions
- Domestic Violence, Substance Abuse
- Being tested
- Motivational Enhancement Therapy, Educational information
- 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.
Motivational Enhancement TherapyBehavioural
Two personal feedback sessions with counselor using motivational interviewing strategies.
Educational informationBehavioural
Educational brochure about legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors
| Study group | Role | What they receive |
|---|---|---|
| Motivational Enhancement Therapy | Experimental | Motivational Enhancement Therapy Receives: Behavioral: Motivational Enhancement Therapy |
| Educational brochure | Other | Intimate Partner Violence, Substance Abuse, and HIV risky behaviors Education Receives: Behavioral: Educational information |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment seeking
Measured: 4 months
Secondary outcomes (1)
self-report of intimate partner violence and substance use
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lyungai Mbilinyi, University of Washington
- Investigators
- Lyungai F Mbilinyi, PhD, Principal investigator, University of Washington School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621334
- Sponsor's protocol ID
- 37863-C
- Other IDs
- R01DA017873
- Acronym
- MDACU
- Status last verified
- Jun 2012
- First submitted
- 16 Aug 2011
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage 1B Study Motivating Substance Abusing Batterers to Seek Treatment.
- ClinicalTrials.gov ID
- NCT01621334
- Acronym / sponsor ID
- MDACU / 37863-C
- Conditions
- Domestic Violence, Substance Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Jun 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.
This research is a stage 1b developmental trial evaluating an intervention called "The Men's Domestic Abuse Check-Up" with adult men abusing their intimate partners and also struggling with alcohol or drug use.
Detailed description
One hundred and forty adult men concerned about their substance use and behaviors toward intimate partners, recruited in Washington State, will be enrolled in the trial. Participants are recruited through print and radio ads. Following a baseline assessment, participants are then randomly assigned to receive one of two interventions:
- The experimental intervention is a two-session motivational enhancement treatment. A personalized feedback report, containing information from the participant's assessment as well as normative comparison data, is reviewed, with the counselor employing motivational interviewing strategies intended to impact study outcomes.
- The comparison condition involves an educational brochure focusing on the legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors.
Following the two interventions, participants are reassessed at 1 week, 1 month, and 4 months following either intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Enhancement Therapy | Experimental | Behavioral: Motivational Enhancement TherapyMotivational Enhancement Therapy |
| Educational brochure | Other | Behavioral: Educational informationIntimate Partner Violence, Substance Abuse, and HIV risky behaviors Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age (18 years and older)
- gender (male)
- self-reported abusive behaviors
- concerned about alcohol or drug use
Key exclusion criteria (3 listed)
- not fluent in English
- they have a thought disorder that precludes full participation
- they refuse to accept randomization to condition
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 TherapyTwo personal feedback sessions with counselor using motivational interviewing strategies. | Behavioural | Motivational Enhancement Therapy |
| Educational informationEducational brochure about legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors | Behavioural | Educational brochure |
Primary outcome
treatment seeking
Time frame: 4 months
1 secondary outcome
self-report of intimate partner violence and substance use
Time frame: 4 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 18 Jun 2012.
Related trials for Domestic Violence
RecruitingObservational study
Self-Dehumanization and Hesitation to Report Domestic Violence
Domestic Violence
Active, not recruiting
Community Resiliency Collective Efficacy Intervention
Violence, Physical, Violence, Non-accidental
Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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.
Lyungai F Mbilinyi, PhD principal investigator
University of Washington School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational Enhancement Therapy and Educational information in people with Domestic Violence and Substance Abuse, run by University of Washington 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 4 inclusion and 3 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 18 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
treatment seeking (time frame: 4 months). 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 Jun 2012.