Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence

March 18, 2013 updated by: Lynette Feder, Portland State University

An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence

An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence; This randomized trial of an intervention to assess and prevent intimate partner violence during pregnancy and the post-partum builds upon the David Olds model of nurse home visitation (Nurse Family Partnership or NFP) for high risk mothers and infants that has shown to be effective in multiple settings in preventing child abuse and enhancing maternal and child health and psychosocial outcomes. However, prior research has shown that the NFP intervention is not as effective in homes where there is intimate partner violence (IPV). Although the NFP by itself has reduced IPV in one setting, it has not in another. The proposed study will test the efficacy of an enhanced NFP intervention, the ECI or Enhanced Choice Intervention among women referred to an existing NFP program in Portland, Oregon. The ECI is based on a choice or empowerment model whereby women can choose among interventions related to her goal for her current intimate relationship. If IPV or emotional abuse or controlling behaviors are assessed, the intervention is based on two interventions shown to be effective in assessing for and reducing repeat IPV (the Sullivan Advocacy Intervention and the McFarlane and Parker brochure driven intervention). For women desiring to enhance marital quality, the Markman and Stanley PREP model that has been shown to enhance relationship quality will be offered. The PREP model also has some preliminary evidence of preventing IPV. For women with other risk factors for IPV in their own or their partners' history (e.g. exposure to parental IPV, child abuse, substance abuse), community resource linkage (beyond referral) strategies as with the NFP model will be used to obtain community resources to address these risk factors. 250 women referred to the Multnomah County Health Department will be randomized to the experimental (NFP plus ECI) or control condition (NFP) and visited according to the regular NFP schedule during pregnancy and until the infant is 24 months old. The intervention will concentrate on the prenatal and immediate (first 6 months) post partum period with regular IPV, emotional abuse and controlling behavior assessments throughout the NFP period. Baseline and outcome measurement (CTS2, WEB, TPMI, depression - Edinborough, & parenting stress), will occur at 3 months before delivery, 9 months & 21 months post-partum with multivariate MANOVA, SEM and growth curve analyses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97204
        • Multnomah County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • No more than 28th week of gestation
  • Low income
  • Speak English or Spanish
  • Pregnant with first child
  • Minimum of 15 years of age at time of entrance into study

Exclusion Criteria:

  • Women experiencing high risk pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Enhanced NFP (NFP+)

Enhanced NFP(NFP+)provides for the usual NFP services plus a three-prong experimental preventive intervention:

  1. Structured and regularly occuring assessments for intimate partner violence (IPV);
  2. McFarlane and Parker Brochure Driven Intervention for women experiencing IPV, including safety planning, referrals, and advocacy; and
  3. Markman and Stanley Within My Reach Training which is a skills-based curriculum delivered to all participants focusing on improving relationship deicsions and outcomes.
Behavioral: Enhanced NFP (NFP+)
Women in the experimental group received three possible interventions. First they received regular and periodic structured intimate partner violence (IPV) assessments from their nurse. Those who indicted any IPV - whether physical violence or emotional abuse or controlling behavior - were then given the Parker-McFarlane Brochure Intervention. Finally, all women were provided the Markman and Stanley Within My Reach curriculum according to their needs and interests.
Other Names:
  • Markman and Stanley Within My Reach Training Curriculum
  • McFarlane and Parker Brochure Driven Intervention
ACTIVE_COMPARATOR: NFP as usual
The Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice.
Behavioral: NFP as usual
The Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice.
Other Names:
  • Nurse Family Partnership

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up.
Time Frame: baseline, one year follow-up, and two year follow-up
Women were given several different standardized measures regarding the amount of physical violence they might be experiencing including the Strauss Conflict Tactic Scale (CTS2r), Relationship Danger Assessment (RDA), and Proximal Antecedents of Violent Episodes Scale (PAVE).
baseline, one year follow-up, and two year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Intimate Partner Emotional Abuse & Controlling Behaviors from Baseline to Two-Year Follow-Up.
Time Frame: baseline, one year follow-up, and two year follow-up
The women in the sample were given several standardized measures regarding emotional abuse and controlling behaviors including the Straus Conflict Tactic Scale (CTS2r), Psychological Maltreatment of Women Inventory (PWMI), Relationship Locus of Control (RLC), Communication Patterns Questionnaire (CPQ), and Relationship Danger Assessment (RDA).
baseline, one year follow-up, and two year follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvements in the Quality of Life from Baseline to Two-Year Follow-Up.
Time Frame: baseline, one year follow-up, and two year follow-up
Women were given several different standardized measures assessing their quality of life including the Quality of Life/Health and Wellbeing (SF-12), Quality of Marriage Index (QMI), Communication Patterns Questionnaire (CPQ).Edinburgh Depression Scale (EDI), Conflict Resolution Strategies (CSR), Relationship Locus of Control (RLC), Prenatal Psychosocial Profile (PPP) - Stress, Social Support, and Self-Esteem, Alcohol Use (AUDIT), Drug Use (DAST-10), Brief Child Abuse Potential Scale (CAPI), and the Parenting Stress Index (PSI).
baseline, one year follow-up, and two year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland State University

Investigators

  • Principal Investigator: Lynette F Feder, PhD, University of Central Florida
  • Principal Investigator: Phyllis Niolin, PhD, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

March 8, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (ESTIMATE)

March 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDC 555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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