Domestic ViolenceNCT00257296
Evaluation of an Intimate Partner Violence Screening-Intervention
A study testing Screening and Intervention in people with Domestic Violence, run by University at Albany.
Trial summary
The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV) screening/intervention targeting abused women who are seen for prenatal care in obstetrics-gynecology clinics or general medical care in internal medicine clinics. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Screening and Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2004to 15 Oct 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females Ages 18 to 45 years Seen at study sites for primary care during study periods Speaks English Able to separate from accompanying person(s) Willing to participant
Who cannot join
- Too ill to participate Unable to separate from accompanying person(s) Unable to speak English Refuse to participant
About this study
The purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV) screening/intervention targeting abused women who are seen for prenatal care in obstetrics-gynecology clinics or general medical care in internal medicine clinics. The intervention is based on our clinical experience and review of the literature which suggests: 1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually occurs over time and not necessarily immediately after it is first detected; 3) women have gone down many different paths leading to an abusive relationship and there is no single path to recovery; 4) for screening/interventions to be credible and ultimately disseminated they must respond to the complexity of the patient stories clinicians see everyday when caring for women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to effectively screen and treat women experiencing IPV unless they are supported by other personnel trained to address IPV as well.
The intervention also is based on recommendations of IPV experts and on the theory of chronic disease management that recognizes that the best outcomes are achieved when: 1) patients are educated and given the support and skills to set their own goals and make their own choices; 2) multidisciplinary teams work better than programs focused only on physician behavior; 3) active monitoring of progress is essential; 4) active coping styles using a range of therapeutic modalities are available and 5) a stepped approach is utilized with those not making progress or with more severe problems receiving the greatest intensity of services.
Read more
The screening/intervention will be available to each abused woman for approximately three to six months. Patients in the evaluation study will be surveyed at the following time points: baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early, 9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as a referent group.
Our primary hypotheses are, that compared to usual care, abused women receiving the intervention will have a reduction in levels of IPV, decreases in depression and nonspecific physical symptoms, increase in functional health status, increase in safety behaviors, increase in help seeking for issues related to IPV, and reduction of general medical services.
- Conditions
- Domestic Violence
- Being tested
- Screening and Intervention, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and InterventionOther
Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient
Usual CareOther
Screening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm.
| Study group | Role | What they receive |
|---|---|---|
| Screening and Intervention | Experimental | Use a computer-based screening tool for intimate partner violence and provide a multi-faceted intervention based on the needs of the woman and services should would like to utilize. Receives: Other: Screening and Intervention |
| Usual Care | Active comparator | Use a computer-based screening tool for intimate partner violence and provide list of resources available. Also, all physicians were trained on intimate partner violence and were told they could help anyone regardless of randomization. Receives: Other: Usual Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study start1 Aug 2004
- Primary completion15 Oct 2005
- Study completion15 Oct 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Louise-Anne McNutt, University at Albany
- Investigators
- Louise-Anne McNutt, PhD, Principal investigator, University at Albany, State University of New YorkDaniel Ford, MD, MS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257296
- Sponsor's protocol ID
- S1751
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2005
- Last updated
- 13 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intimate Partner Violence Screening-Intervention
- ClinicalTrials.gov ID
- NCT00257296
- Acronym / sponsor ID
- S1751
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Aug 2004 (actual)
- Primary completion
- 15 Oct 2005 (actual)
- Study completion
- 15 Oct 2005 (actual)
- First posted
- 22 Nov 2005 (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 purpose of the study is to evaluate a multi-faceted intimate partner violence (IPV) screening/intervention targeting abused women who are seen for prenatal care in obstetrics-gynecology clinics or general medical care in internal medicine clinics. The intervention is based on our clinical experience and review of the literature which suggests: 1) IPV can vary and no one pattern exists for all women; 2) recovery from abuse usually occurs over time and not necessarily immediately after it is first detected; 3) women have gone down many different paths leading to an abusive relationship and there is no single path to recovery; 4) for screening/interventions to be credible and ultimately disseminated they must respond to the complexity of the patient stories clinicians see everyday when caring for women experiencing IPV and 5) busy obstetricians/internists/clinicians are unlikely to effectively screen and treat women experiencing IPV unless they are supported by other personnel trained to address IPV as well.
The intervention also is based on recommendations of IPV experts and on the theory of chronic disease management that recognizes that the best outcomes are achieved when: 1) patients are educated and given the support and skills to set their own goals and make their own choices; 2) multidisciplinary teams work better than programs focused only on physician behavior; 3) active monitoring of progress is essential; 4) active coping styles using a range of therapeutic modalities are available and 5) a stepped approach is utilized with those not making progress or with more severe problems receiving the greatest intensity of services.
The screening/intervention will be available to each abused woman for approximately three to six months. Patients in the evaluation study will be surveyed at the following time points: baseline, 1 week, 1 month, 3 months, 6 months, and for the partial cohort that starts early, 9 months. Additionally, a sample of nonabused women will be surveyed at baseline to serve as a referent group.
Our primary hypotheses are, that compared to usual care, abused women receiving the intervention will have a reduction in levels of IPV, decreases in depression and nonspecific physical symptoms, increase in functional health status, increase in safety behaviors, increase in help seeking for issues related to IPV, and reduction of general medical services.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening and Intervention | Experimental | Other: Screening and InterventionUse a computer-based screening tool for intimate partner violence and provide a multi-faceted intervention based on the needs of the woman and services should would like to utilize. |
| Usual Care | Active comparator | Other: Usual CareUse a computer-based screening tool for intimate partner violence and provide list of resources available. Also, all physicians were trained on intimate partner violence and were told they could help anyone regardless of randomization. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females Ages 18 to 45 years Seen at study sites for primary care during study periods Speaks English Able to separate from accompanying person(s) Willing to participant
Key exclusion criteria (1 listed)
- Too ill to participate Unable to separate from accompanying person(s) Unable to speak English Refuse to participant
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 |
|---|---|---|
| Screening and InterventionScreening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient | Other | Screening and Intervention |
| Usual CareScreening for intimate partner violence and provide enhanced usual care which includes providing resource list, educating medical staff and partner violence and instructing physicians to help all patients regardless of assigned arm. | Other | Usual Care |
Primary outcome
Not reported in the source record.
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 13 Feb 2018.
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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.
Louise-Anne McNutt, PhD principal investigator
University at Albany, State University of New York
Daniel Ford, MD, MS principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Screening and Intervention in people with Domestic Violence, run by University at Albany.
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 1 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: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 13 Feb 2018.