Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynette Feder, University of Central Florida
ClinicalTrials.gov Identifier:
NCT01811719
First received: March 8, 2013
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Violence
Emotional Abuse
Pregnancy
Parenting
Behavioral: Enhanced NFP (NFP+)
Behavioral: NFP as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence

Resource links provided by NLM:


Further study details as provided by Portland State University:

Primary Outcome Measures:
  • Decreased Intimate Partner Physical Violence from Baseline to Two-Year Follow-Up. [ Time Frame: baseline, one year follow-up, and two year follow-up ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 238
Study Start Date: January 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nurse Family Partnership

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811719

Locations
United States, Oregon
Multnomah County Health Department
Portland, Oregon, United States, 97204
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Lynette Feder, Assistant Dean and Director, PAF Doctoral Program, University of Central Florida
ClinicalTrials.gov Identifier: NCT01811719     History of Changes
Other Study ID Numbers: CDC 555
Study First Received: March 8, 2013
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Portland State University:
Intimate Partner Physical Violence
Intimate Partner Emotional Abuse
Intimate Partner Controlling Behaivor
Pregnancy Outcomes
Quality of Parental Care Giving
Maternal Life Course

ClinicalTrials.gov processed this record on September 18, 2014