Clinical trial NCT01372098: Nurse-family Partnership (NFP) Curriculum Study
Official title: Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Keywords: Domestic Violence
Spouse Abuse
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Public Health Agency of Canada (PHAC)
name: Annie E. Casey Foundation
First posted: 2011-06-13
Enrollment: 492
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in WHO Quality of Life-BREF at 6, 12, 18, and 24 months
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
Secondary outcomes:
measure: The Composite Abuse Scale (CAS)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: The Domestic Violence Survivor Assessment (DVSA)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: PRIME-MD Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: SPAN (Startle, Physiological arousal, Anger and Numbness)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: The SF-12 (v. 2)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: The TWEAK
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: Drug Abuse Screening Tool (DAST)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: The Intimate Partner Violence Strategies Index (IPV Strategies)
timeFrame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
measure: The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)
timeFrame: 6-month postpartum
measure: The Childhood Trauma Questionnaire (CTQ)
timeFrame: 6-month postpartum
measure: A modified version of the Health and Social Service Utilization questionnaire
timeFrame: 6-,12-, 18-, and 24-month postpartum
measure: Child health outcomes
timeFrame: Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum
measure: Child Protection Service records
timeFrame: 24-month postpartum
measure: The Public Health Nurses' Responses to Women Who Are Abused
timeFrame: Collected from nurses at baseline, 12 and 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 600 S. Commonwealth Ave., #800
state: California
Study officials:
affiliation: McMaster University
name: Harriet MacMillan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalra N, Hooker L, Reisenhofer S, Di Tanna GL, Garcia-Moreno C. Training healthcare providers to respond to intimate partner violence against women. Cochrane Database Syst Rev. 2021 May 31;5(5):CD012423. doi: 10.1002/14651858.CD012423.pub2.
citation: Jack SM, Boyle M, McKee C, Ford-Gilboe M, Wathen CN, Scribano P, Davidov D, McNaughton D, O'Brien R, Johnston C, Gasbarro M, Tanaka M, Kimber M, Coben J, Olds DL, MacMillan HL. Effect of Addition of an Intimate Partner Violence Intervention to a Nurse Home Visitation Program on Maternal Quality of Life: A Randomized Clinical Trial. JAMA. 2019 Apr 23;321(16):1576-1585. doi: 10.1001/jama.2019.3211.