Nurse-family Partnership (NFP) Curriculum Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Annie E. Casey Foundation
Information provided by (Responsible Party):
Harriet L. MacMillan, McMaster University
ClinicalTrials.gov Identifier:
NCT01372098
First received: June 9, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Domestic Violence
Behavioral: NFP + IPV intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Composite Abuse Scale (CAS) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.

  • The Domestic Violence Survivor Assessment (DVSA) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    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.

  • PRIME-MD Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Depression measure.

  • SPAN (Startle, Physiological arousal, Anger and Numbness) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Post-Traumatic Stress Disorder measure.

  • The SF-12 (v. 2) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Mental and Physical Health

  • The TWEAK [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Screening tool for alcohol abuse/dependency.

  • Drug Abuse Screening Tool (DAST) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Prescription and Street Drug Use.

  • The Intimate Partner Violence Strategies Index (IPV Strategies) [ Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Specific actions women take to cope with violence.

  • The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF) [ Time Frame: 6-month postpartum ] [ Designated as safety issue: No ]
    Childhood maltreatment

  • The Childhood Trauma Questionnaire (CTQ) [ Time Frame: 6-month postpartum ] [ Designated as safety issue: No ]
    Childhood maltreatment.

  • A modified version of the Health and Social Service Utilization questionnaire [ Time Frame: 6-,12-, 18-, and 24-month postpartum ] [ Designated as safety issue: No ]
    Assessment of service utilization.

  • Child health outcomes [ Time Frame: Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum ] [ Designated as safety issue: No ]
    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.

  • Child Protection Service records [ Time Frame: 24-month postpartum ] [ Designated as safety issue: No ]
    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 Public Health Nurses' Responses to Women Who Are Abused [ Time Frame: Collected from nurses at baseline, 12 and 24 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 510
Study Start Date: May 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: NFP + IPV intervention
The intervention focuses on helping women stay safe in a relationship. Strategies for overcoming barriers to using and accessing community resources and services, and community agency interventions for women exposed to IPV is built into the intervention.
No Intervention: NFP (standard care)
The NFP nurses currently receive some training regarding IPV, but it is minimal. Between intake and when the child is 3 months and 12 months old, there is a brief instruction that the nurse assess for IPV. If the client acknowledges current abuse when completing the Abuse Assessment Screen, the nurse should "assist her to evaluate threats to personal safety and make referrals as needed". There is a prompt to be mindful of client safety, and to make referrals as needed.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Woman who cannot communicate in English

  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: NCT01372098

Locations
United States, California
600 S. Commonwealth Ave., #800
Los Angeles, California, United States, 90005
Sponsors and Collaborators
McMaster University
Public Health Agency of Canada (PHAC)
Annie E. Casey Foundation
Investigators
Principal Investigator: Harriet MacMillan, MD McMaster University
  More Information

No publications provided

Responsible Party: Harriet L. MacMillan, Professor of Pediatrics, McMaster University
ClinicalTrials.gov Identifier: NCT01372098     History of Changes
Other Study ID Numbers: MacMillan_NFP_IPVI_RCT
Study First Received: June 9, 2011
Last Updated: February 27, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Domestic Violence
Spouse Abuse

ClinicalTrials.gov processed this record on August 18, 2014