Nurse-family Partnership (NFP) Curriculum Study

Not Applicable

Completed

• Conditions: Domestic Violence
• Interventions: Behavioral: NFP + IPV intervention

• Registration Number: NCT01372098
• Lead Sponsor: McMaster University

Brief Summary

The purpose of this study is to determine whether the Intimate Partner Violence (IPV) intervention in the context of Nurse-Family Partnership (NFP) program improves women's quality of life and reduces violence relative to the NFP alone using a cluster randomized controlled trial. Our hypothesis is that an IPV intervention can be designed that is acceptable to participants in the NFP, feasible to implement, and that this intervention will improve quality of life for women and reduce exposure to violence.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-13
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 492

Inclusion Criteria

• Age 16 years and older
• NFP program participants (woman with first live birth and living in poverty)
• English speaker

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Exclusion Criteria

• Woman who cannot communicate in English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NFP + IPV intervention	NFP + IPV intervention	The protocol for number and timing of visits will be the same for both NFP+IPVI and Standard Care, as follows: weekly for the first four visits, every other week for the remainder of the pregnancy, every week for six weeks in the postpartum and every other week until the infant is 21 months old after which it is once a month for the last three months. We recognize that the intervention might prompt the nurse and mother to alter the regular visit schedule if IPV is present.

Primary Outcome Measures

Name	Time	Method
Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

Secondary Outcome Measures

Name	Time	Method
PRIME-MD Patient Health Questionnaire (PHQ-9)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Depression measure.
The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)	6-month postpartum	Childhood maltreatment
The Public Health Nurses' Responses to Women Who Are Abused	Collected from nurses at baseline, 12 and 24 months	Nurses' readiness to treat IPV. In the 20-item PHNR, nurses respond to one of two scenarios that resemble real-life experiences they would encounter in a postpartum home visit. The instrument measures nurses' thoughts, feeling and actions in response to identifying and responding to IPV. The PHNR has good internal consistency with an overall Cronbach alpha of 0.79.
The TWEAK	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Screening tool for alcohol abuse/dependency.
The Intimate Partner Violence Strategies Index (IPV Strategies)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Specific actions women take to cope with violence.
The Childhood Trauma Questionnaire (CTQ)	6-month postpartum	Childhood maltreatment.
Drug Abuse Screening Tool (DAST)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Prescription and Street Drug Use.
A modified version of the Health and Social Service Utilization questionnaire	6-,12-, 18-, and 24-month postpartum	Assessment of service utilization.
Child Protection Service records	24-month postpartum	Number of reports made, cases of confirmed child maltreatment, the type of maltreatment, the duration that cases were open, and whether children were placed in foster care or in custody of another family member.
The Domestic Violence Survivor Assessment (DVSA)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Based on Prochaska's Transtheoretical Model of Behaviour Change (also known as "stages of change") and was developed by Dienemann and colleagues to gain a better understanding of battered women's cognitive states during counseling.
The SF-12 (v. 2)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Mental and Physical Health
Child health outcomes	Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum	Data regarding the following child health outcomes are gathered by maternal interview: 1) birth weight; 2) length of gestation; 3) injuries; 4) emergency department visits (including those that are injury-related); 5) hospitalizations; 6) immunizations; and 7) developmental delay.
The Composite Abuse Scale (CAS)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.
SPAN (Startle, Physiological arousal, Anger and Numbness)	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	Post-Traumatic Stress Disorder measure.

Trial Locations

Locations (1)

600 S. Commonwealth Ave., #800; 🇺🇸 Los Angeles, California, United States