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Evaluation of an Intimate Partner Violence Screening-Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00257296
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Louise-Anne McNutt, University at Albany

Tracking Information
First Submitted Date  ICMJE November 21, 2005
First Posted Date  ICMJE November 22, 2005
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE August 1, 2004
Actual Primary Completion Date October 15, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Intimate Partner Violence Screening-Intervention
Official Title  ICMJE Evaluation of an Intimate Partner Violence Screening-Intervention
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Domestic Violence
Intervention  ICMJE
  • Other: Screening and Intervention
    Screening for intimate partner violence and providing a multi-faceted intervention which depends on the needs of the patient
  • Other: 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.
Study Arms  ICMJE
  • Experimental: Screening and Intervention
    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.
    Intervention: Other: Screening and Intervention
  • Active Comparator: Usual Care
    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.
    Intervention: Other: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2018)
471
Original Enrollment  ICMJE
 (submitted: November 21, 2005)
2000
Actual Study Completion Date  ICMJE October 15, 2005
Actual Primary Completion Date October 15, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00257296
Other Study ID Numbers  ICMJE S1751
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Louise-Anne McNutt, University at Albany
Study Sponsor  ICMJE University at Albany
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Louise-Anne McNutt, PhD University at Albany, State University of New York
Principal Investigator: Daniel Ford, MD, MS Johns Hopkins University
PRS Account University at Albany
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP