Clinical trial NCT01811719: Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence
Official title: An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Portland State University
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 238
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up.
timeFrame: baseline, one year follow-up, and two year follow-up
Secondary outcomes:
measure: Decreased Intimate Partner Emotional Abuse & Controlling Behaviors from Baseline to Two-Year Follow-Up.
timeFrame: baseline, one year follow-up, and two year follow-up
Other outcomes:
measure: Improvements in the Quality of Life from Baseline to Two-Year Follow-Up.
timeFrame: baseline, one year follow-up, and two year follow-up
Locations:
city: Portland
country: United States
facility: Multnomah County Health Department
state: Oregon
Study officials:
affiliation: University of Central Florida
name: Lynette F Feder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Phyllis Niolin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.