Nurse-family Partnership (NFP) Curriculum Study

Domestic Violence Clinical Trial

Official title:

Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372098
• Other study ID #: MacMillan_NFP_IPVI_RCT
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: June 8, 2015
• Start date: May 2011
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Domestic Violence

Intervention

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.

Locations

Country	Name	City	State
United States	600 S. Commonwealth Ave., #800	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Annie E. Casey Foundation, Centers for Disease Control and Prevention, Public Health Agency of Canada (PHAC)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Composite Abuse Scale (CAS)	Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	The Domestic Violence Survivor Assessment (DVSA)	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.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	PRIME-MD Patient Health Questionnaire (PHQ-9)	Depression measure.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	SPAN (Startle, Physiological arousal, Anger and Numbness)	Post-Traumatic Stress Disorder measure.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	The SF-12 (v. 2)	Mental and Physical Health	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	The TWEAK	Screening tool for alcohol abuse/dependency.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	Drug Abuse Screening Tool (DAST)	Prescription and Street Drug Use.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	The Intimate Partner Violence Strategies Index (IPV Strategies)	Specific actions women take to cope with violence.	Baseline, 3-, 6-,12-, 18-, and 24-month postpartum	No
Secondary	The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)	Childhood maltreatment	6-month postpartum	No
Secondary	The Childhood Trauma Questionnaire (CTQ)	Childhood maltreatment.	6-month postpartum	No
Secondary	A modified version of the Health and Social Service Utilization questionnaire	Assessment of service utilization.	6-,12-, 18-, and 24-month postpartum	No
Secondary	Child health outcomes	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.	Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum	No
Secondary	Child Protection Service records	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.	24-month postpartum	No
Secondary	The Public Health Nurses' Responses to Women Who Are Abused	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.	Collected from nurses at baseline, 12 and 24 months	No