NCT01811719

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

3.8 years

First QC Date

March 8, 2013

Last Update Submit

March 18, 2013

Conditions

Keywords

Intimate Partner Physical ViolenceIntimate Partner Emotional AbuseIntimate Partner Controlling BehaivorPregnancy OutcomesQuality of Parental Care GivingMaternal Life Course

Outcome Measures

Primary Outcomes (1)

  • Decreased Intimate Partner Physical Violence from Baseline to 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 Outcomes (1)

  • Decreased Intimate Partner Emotional Abuse & Controlling Behaviors from Baseline to Two-Year Follow-Up.

    baseline, one year follow-up, and two year follow-up

Other Outcomes (1)

  • Improvements in the Quality of Life from Baseline to Two-Year Follow-Up.

    baseline, one year follow-up, and two year follow-up

Study Arms (2)

Enhanced NFP (NFP+)

EXPERIMENTAL

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+)

NFP as usual

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Markman and Stanley Within My Reach Training Curriculum, McFarlane and Parker Brochure Driven Intervention
Enhanced NFP (NFP+)
NFP as usualBEHAVIORAL

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.

Also known as: Nurse Family Partnership
NFP as usual

Eligibility Criteria

Age15 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Women experiencing high risk pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multnomah County Health Department

Portland, Oregon, 97204, United States

Location

Related Publications (2)

  • Li Q, Riosmena F, Valverde PA, Zhou S, Amura C, Peterson KA, Palusci VJ, Feder L. Preventing intimate partner violence among foreign-born Latinx mothers through relationship education during nurse home visiting. J Nurs Manag. 2022 Sep;30(6):1639-1647. doi: 10.1111/jonm.13565. Epub 2022 Mar 7.

  • Feder L, Niolon PH, Campbell J, Whitaker DJ, Brown J, Rostad W, Bacon S. An Intimate Partner Violence Prevention Intervention in a Nurse Home Visitation Program: A Randomized Clinical Trial. J Womens Health (Larchmt). 2018 Dec;27(12):1482-1490. doi: 10.1089/jwh.2017.6599. Epub 2018 Oct 11.

MeSH Terms

Interventions

Neurofilament Proteins

Intervention Hierarchy (Ancestors)

Intermediate Filament ProteinsBiopolymersPolymersMacromolecular SubstancesCytoskeletal ProteinsProteinsAmino Acids, Peptides, and ProteinsNerve Tissue Proteins

Study Officials

  • Lynette F Feder, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR
  • Phyllis Niolin, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Dean and Director, PAF Doctoral Program

Study Record Dates

First Submitted

March 8, 2013

First Posted

March 15, 2013

Study Start

January 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations