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CompletedNCT01811719Updated Mar 19, 2013

Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence

An interventional study of Enhanced NFP (NFP+) and NFP as usual in Violence, Emotional Abuse and Pregnancy, sponsored by Portland State University. Completed at 1 site in United States. Open to female participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-19.

Sponsored by Portland State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
15 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Violence
  • Emotional Abuse
  • Pregnancy
  • Parenting

Keywords

  • Intimate Partner Physical Violence
  • Intimate Partner Emotional Abuse
  • Intimate Partner Controlling Behaivor
  • Pregnancy Outcomes
  • Quality of Parental Care Giving
  • Maternal Life Course
03

In context

Lead sponsor

Portland State University is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Women experiencing high risk pregnancies
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
238 participants (actual)

Study arms

  • 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+)

  • 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

Interventions

  • BehavioralEnhanced 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.

    Also known as: Markman and Stanley Within My Reach Training Curriculum, McFarlane and Parker Brochure Driven Intervention

  • BehavioralNFP 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.

    Also known as: Nurse Family Partnership

06

What researchers measure

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).

    Time frame: 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.

    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).

    Time frame: 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.

    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).

    Time frame: baseline, one year follow-up, and two year follow-up

07

Study locations

1 site
  • Multnomah County Health Department
    Portland, Oregon 97204, United States
08

References and documents

Publications

  • 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. PubMed 35174575 ↗
  • 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. PubMed 30311848 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007, a primary completion of Oct 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2013
First posted
Mar 15, 2013
Start
Jan 2007
Primary completionActual
Oct 2010
CompletionActual
Oct 2010
Last update
Mar 19, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01811719
Lead sponsor
Portland State University
Responsible party
Lynette Feder (Assistant Dean and Director, PAF Doctoral Program, University of Central Florida) — Principal investigator
First posted
Mar 15, 2013
Start date
Jan 2007
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Mar 19, 2013

Study contacts

Lynette F Feder, PhD
principal investigator · University of Central Florida
Phyllis Niolin, PhD
principal investigator · Centers for Disease Control and Prevention

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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