Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits

McMaster University1 site in 1 country492 target enrollmentMay 2011

ConditionsDomestic Violence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Domestic Violence
Sponsor: McMaster University
Enrollment: 492
Locations: 1
Primary Endpoint: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

McMaster University

Responsible Party

Principal Investigator

Harriet L. MacMillan

Professor of Pediatrics

McMaster University

Eligibility Criteria

Inclusion Criteria

•Age 16 years and older
•NFP program participants (woman with first live birth and living in poverty)
•English speaker

Exclusion Criteria

•Woman who cannot communicate in English

Outcomes

Primary Outcomes

Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months

Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

Secondary Outcomes

PRIME-MD Patient Health Questionnaire (PHQ-9)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)(6-month postpartum)
The Public Health Nurses' Responses to Women Who Are Abused(Collected from nurses at baseline, 12 and 24 months)
The TWEAK(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
The Intimate Partner Violence Strategies Index (IPV Strategies)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
The Childhood Trauma Questionnaire (CTQ)(6-month postpartum)
Drug Abuse Screening Tool (DAST)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
A modified version of the Health and Social Service Utilization questionnaire(6-,12-, 18-, and 24-month postpartum)
Child Protection Service records(24-month postpartum)
The Domestic Violence Survivor Assessment (DVSA)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
The SF-12 (v. 2)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
Child health outcomes(Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum)
The Composite Abuse Scale (CAS)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)
SPAN (Startle, Physiological arousal, Anger and Numbness)(Baseline, 3-, 6-,12-, 18-, and 24-month postpartum)