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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00257296
Other study ID # S1751
Secondary ID
Status Completed
Phase N/A
First received November 21, 2005
Last updated February 9, 2018
Start date August 1, 2004
Est. completion date October 15, 2005

Study information

Verified date February 2018
Source University at Albany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 471
Est. completion date October 15, 2005
Est. primary completion date October 15, 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Too ill to participate Unable to separate from accompanying person(s) Unable to speak English Refuse to participant

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Screening and Intervention
Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient
Usual Care
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University at Albany Johns Hopkins University
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