Domestic ViolenceNCT00336297
Testing Methods of Screening for Woman Abuse in Health Care Settings.
A study testing Woman Abuse Screening Tool, Partner Violence Screen and Computerized screening in people with Domestic Violence, run by Hamilton Health Sciences Corporation at 7 sites in Canada.
Trial summary
Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Woman Abuse Screening Tool, Partner Violence Screen and Computerized screening
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 7 sitesCanada
- Study dates
- May 2004to Feb 2005
- Phase
- Interventional
- 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 to 64 years
- Women only
- Adult
Who may be able to join
- Women aged 18-64 years
- Patients at the health care site
- Able to participate in English
- Able to separate from accompanying person(s)
Who cannot join
- Too ill to participate
- Unable to separate from accompanying person(s)
- Unable to speak, read, or write English
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Cambridge Memorial Hospital - Emergency Department
Cambridge, Ontario
Carlisle Medical Centre
Carlisle, Ontario, L0R 1H0
City of Hamilton Public Health and Community Services Department
Hamilton, Ontario, L8R 3L5
Hamilton Health Sciences Colposcopy Clinic
Hamilton, Ontario, L8V 1C3
Victoria Family Medical Centre
London, Ontario, N5Z 2C1
London Health Sciences - Victoria Hospital Clinic 5A
London, Ontario, N6A 5W9
Norfolk General Hospital - Emergency Department
Simcoe, Ontario, N3Y 1T7
About this study
Official title: Testing Screening Formats for Indicator-Based and Universal Screening Measurements in the Identification of Woman Abuse.
Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through screening -- either universal or indicator-based is effective in preventing or ameliorating important outcomes. This is a critical first step in developing a larger randomized controlled trial (RCT) which examines the effectiveness of screening in preventing woman abuse, improving quality of life and other associated outcomes. This study prepares for the RCT by testing the optimal method of administration for the two screening instruments that will be used in the RCT. The administration formats are: computer-based screen, paper and pencil screen and face-to-face screen. They study will also determine recruitment rates.
- Conditions
- Domestic Violence
- Being tested
- Woman Abuse Screening Tool, Partner Violence Screen, Computerized screening, Face to face screening, Written screening on forms
- Keywords
- screening, screening methods, intimate partner violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woman Abuse Screening ToolProcedure or surgery
Partner Violence ScreenProcedure or surgery
Computerized screeningProcedure or surgery
Face to face screeningProcedure or surgery
Written screening on formsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
disclosure rates for past year exposure to intimate partner violence
Secondary outcomes (2)
participant satisfaction with completing the instruments
missing data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startMay 2004
- Study completionFeb 2005
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Women's Health Council
- Investigators
- Harriet L MacMillan, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336297
- Sponsor's protocol ID
- MacMillan_VAW_Testing_Trial
- Status last verified
- Feb 2005
- First submitted
- 9 Jun 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
Publications
MacMillan HL, Wathen CN, Jamieson E, Boyle M, McNutt LA, Worster A, Lent B, Webb M; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006 Aug 2;296(5):530-6. doi: 10.1001/jama.296.5.530.
PubMed 16882959
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Screening Formats for Indicator-Based and Universal Screening Measurements in the Identification of Woman Abuse.
- ClinicalTrials.gov ID
- NCT00336297
- Acronym / sponsor ID
- MacMillan_VAW_Testing_Trial
- Conditions
- Domestic Violence
- Keywords
- screening, screening methods, intimate partner violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Ontario Women's Health Council
- Study start
- May 2004
- Study completion
- Feb 2005
- First posted
- 13 Jun 2006 (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.
Recent reviews have identified the need for additional high quality exploratory and evaluative research to understand 1) the actual impact on all women of instituting mass screening procedures versus using indicator-based approaches to identifying woman abuse and 2) the extent to which early identification through screening -- either universal or indicator-based is effective in preventing or ameliorating important outcomes. This is a critical first step in developing a larger randomized controlled trial (RCT) which examines the effectiveness of screening in preventing woman abuse, improving quality of life and other associated outcomes. This study prepares for the RCT by testing the optimal method of administration for the two screening instruments that will be used in the RCT. The administration formats are: computer-based screen, paper and pencil screen and face-to-face screen. They study will also determine recruitment rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 18-64 years
- Patients at the health care site
- Able to participate in English
- Able to separate from accompanying person(s)
Key exclusion criteria (3 listed)
- Too ill to participate
- Unable to separate from accompanying person(s)
- Unable to speak, read, or write English
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 |
|---|---|---|
| Woman Abuse Screening Tool | Procedure or surgery | – |
| Partner Violence Screen | Procedure or surgery | – |
| Computerized screening | Procedure or surgery | – |
| Face to face screening | Procedure or surgery | – |
| Written screening on forms | Procedure or surgery | – |
Primary outcome
disclosure rates for past year exposure to intimate partner violence
2 secondary outcomes
participant satisfaction with completing the instruments
missing data
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 29 Nov 2006.
- Results publication: PubMed 16882959MacMillan HL, Wathen CN, Jamieson E, Boyle M, McNutt LA, Worster A, Lent B, Webb M; McMaster Violence Against Women Research Group. Approaches to screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2006 Aug 2;296(5):530-6. doi: 10.1001/jama.296.5.530.
- Protocol for the subsequent RCT of effectiveness of screening for intimate partner violence.Link provided by the sponsor.
Related trials for Domestic Violence
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Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
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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.
Harriet L MacMillan, MD, MSc principal investigator
McMaster University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Woman Abuse Screening Tool, Partner Violence Screen and Computerized screening in people with Domestic Violence, run by Hamilton Health Sciences Corporation at 7 sites in Canada.
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 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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.
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?
disclosure rates for past year exposure to intimate partner violence. 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 NCT00336297, 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 29 Nov 2006.