Enhanced Nurse Home Visitation to Prevent Intimate Partner Violence

Pregnancy Clinical Trial

Official title:

An Enhanced Nurse Home Visitation Program To Prevent Intimate Partner Violence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811719
• Other study ID #: CDC 555
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: March 18, 2013
• Start date: January 2007
• Est. completion date: October 2010

Study information

• Verified date: March 2013
• Source: Portland State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emotional Abuse
• Parenting
• Pregnancy
• Violence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Multnomah County Health Department	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	baseline, one year follow-up, and two year follow-up	Yes
Primary	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	Yes
Secondary	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).	baseline, one year follow-up, and two year follow-up	Yes