NCT01372098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

June 9, 2011

Last Update Submit

June 8, 2015

Conditions

Domestic Violence

Keywords

Domestic ViolenceSpouse Abuse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • The Composite Abuse Scale (CAS)

    Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

  • The Domestic Violence Survivor Assessment (DVSA)

    Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

  • PRIME-MD Patient Health Questionnaire (PHQ-9)

    Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

  • SPAN (Startle, Physiological arousal, Anger and Numbness)

    Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

  • The SF-12 (v. 2)

    Baseline, 3-, 6-,12-, 18-, and 24-month postpartum

  • +9 more secondary outcomes

Study Arms (2)

NFP + IPV intervention

EXPERIMENTAL

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

NFP (standard care)

NO INTERVENTION

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.

Interventions

NFP + IPV interventionBEHAVIORAL

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.

NFP + IPV intervention

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Woman who cannot communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

600 S. Commonwealth Ave., #800

Los Angeles, California, 90005, United States

Location

Related Publications (2)

  • 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.

    PMID: 34057734DERIVED

  • 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.

    PMID: 31012933DERIVED

MeSH Terms

Interventions

Neurofilament Proteins

Intervention Hierarchy (Ancestors)

Intermediate Filament ProteinsBiopolymersPolymersMacromolecular SubstancesCytoskeletal ProteinsProteinsAmino Acids, Peptides, and ProteinsNerve Tissue Proteins

Study Officials

  • Harriet MacMillan, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 13, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations

US(1)