Domestic ViolencePhase 1NCT00070863
Treatment for Men Who Are Abusive to Their Partners
A Phase 1 study testing Individual Cognitive Behavioral Therapy in people with Domestic Violence, run by University of Maryland, Baltimore County at 1 site in United States.
Trial summary
This study will develop an individual behavior therapy for men who are violent toward their partners and will compare the therapy to standard group treatment. 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
- What is being tested?
- Individual Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Dec 2005
- 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
- Involved in male-to-female physical aggression in the past 12 months or has a history of severe male-to-female aggression in a relationship
- Current involvement in a primary intimate relationship (cohabiting, dating, or married) for at least 6 months, with partner contact at least once per week
- Willingness to provide written consent for partner contact
- Partner provides verbal assent for the use of information during an initial phone interview and agrees to be re-contacted for scheduled follow-up interviews
Who cannot join
- Psychotic symptoms or severe mood disorder
- Mental retardation, autism, dementia, delirium, catatonia, or other severe cognitive disorders
- Severe head trauma in the past two years
- Seizure disorder
- Current diagnosis of alcohol dependence or drug dependence. Participants must be in remission for at least 6 months if a past diagnosis is present.
Trial locations and contacts
1 site in 1 country.
United States1 site
Domestic Violence Center of Howard County
Columbia, Maryland, 21045
About this study
Official title: Behavior Therapy for Partner Violent Men
This study will develop an individual behavior therapy for men who are violent toward their partners and will compare the therapy to standard group treatment.
Read the detailed description
To date, treatment interventions for domestic abuse perpetrators have been conducted almost exclusively in groups. However, the efficacy of such treatments relative to no treatment has not been thoroughly evaluated. Evidence suggests that individual treatments may be more effective than group treatments. This study will combine motivational enhancement therapy with cognitive and behavior change techniques to treat men who abuse their partners.
This study will be conducted in two phases. In Phase 1, an individual cognitive behavior therapy (ICBT) manual will be constructed. During Phase 2, participants will be randomly assigned to receive either 16 sessions of ICBT or 16 sessions of standard group therapy. Data on abusive behavior outcomes and secondary treatment targets will be collected from participants and their partners every 3 months for 1 year after the study.
- Conditions
- Domestic Violence
- Being tested
- Individual Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Cognitive Behavioral TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men study of physical assault, emotional abuse, and injury as reported by the male participant and his relationship partner
Physical assault, emotional abuse, and injury as reported by the male participant and his relationship partner
Measured: Three month intervals for one year after the initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2003 (estimated)
- Study startJun 2002
- Primary completionDec 2005
- Study completionDec 2005
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.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore County
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Timothy A Sparklin, University of Maryland, Baltimore County
- Investigators
- Christopher M. Murphy, PhD, Principal investigator, University of Maryland, Baltimore County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070863
- Sponsor's protocol ID
- R21MH064562
- Other IDs
- R21MH064562, DSIR AT-AS
- Status last verified
- Oct 2017
- First submitted
- 8 Oct 2003
- Last updated
- 1 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Therapy for Partner Violent Men
- ClinicalTrials.gov ID
- NCT00070863
- Acronym / sponsor ID
- R21MH064562
- Conditions
- Domestic Violence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of Maryland, Baltimore CountyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 9 Oct 2003 (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 will develop an individual behavior therapy for men who are violent toward their partners and will compare the therapy to standard group treatment.
Detailed description
To date, treatment interventions for domestic abuse perpetrators have been conducted almost exclusively in groups. However, the efficacy of such treatments relative to no treatment has not been thoroughly evaluated. Evidence suggests that individual treatments may be more effective than group treatments. This study will combine motivational enhancement therapy with cognitive and behavior change techniques to treat men who abuse their partners.
This study will be conducted in two phases. In Phase 1, an individual cognitive behavior therapy (ICBT) manual will be constructed. During Phase 2, participants will be randomly assigned to receive either 16 sessions of ICBT or 16 sessions of standard group therapy. Data on abusive behavior outcomes and secondary treatment targets will be collected from participants and their partners every 3 months for 1 year after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Involved in male-to-female physical aggression in the past 12 months or has a history of severe male-to-female aggression in a relationship
- Current involvement in a primary intimate relationship (cohabiting, dating, or married) for at least 6 months, with partner contact at least once per week
- Willingness to provide written consent for partner contact
- Partner provides verbal assent for the use of information during an initial phone interview and agrees to be re-contacted for scheduled follow-up interviews
Key exclusion criteria (5 listed)
- Psychotic symptoms or severe mood disorder
- Mental retardation, autism, dementia, delirium, catatonia, or other severe cognitive disorders
- Severe head trauma in the past two years
- Seizure disorder
- Current diagnosis of alcohol dependence or drug dependence. Participants must be in remission for at least 6 months if a past diagnosis is present.
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 |
|---|---|---|
| Individual Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men study of physical assault, emotional abuse, and injury as reported by the male participant and his relationship partner
Time frame: Three month intervals for one year after the initiation of treatment
Physical assault, emotional abuse, and injury as reported by the male participant and his relationship partner
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 1 Nov 2017.
Related trials for Domestic Violence
RecruitingObservational study
Self-Dehumanization and Hesitation to Report Domestic Violence
Domestic Violence
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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.
Christopher M. Murphy, PhD principal investigator
University of Maryland, Baltimore County
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 Individual Cognitive Behavioral Therapy in people with Domestic Violence, run by University of Maryland, Baltimore County 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 5 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 1 Nov 2017. 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?
Individual Versus Group Cognitive-Behavioral Therapy for Partner-Violent Men study of physical assault, emotional abuse, and injury as reported by the male participant and his relationship partner (time frame: Three month intervals for one year after the initiation of treatment). 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 1 Nov 2017.