Nurse-family Partnership (NFP) Curriculum Study

NCT ID: NCT01372098

Last Updated: 2015-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2015-05-31

Brief Summary

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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

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Conditions

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Domestic Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

NFP + IPV intervention

Intervention Type BEHAVIORAL

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 (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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

Annie E. Casey Foundation

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Harriet L. MacMillan

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harriet MacMillan, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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600 S. Commonwealth Ave., #800

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34057734 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31012933 (View on PubMed)

Other Identifiers

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MacMillan_NFP_IPVI_RCT

Identifier Type: -

Identifier Source: org_study_id

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