- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01372098
Nurse-family Partnership (NFP) Curriculum Study
June 8, 2015 updated by: Harriet L. MacMillan, McMaster University
Development and Evaluation of an Intervention for Intimate Partner Violence in the Context of Nurse Home Visits
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
492
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90005
- 600 S. Commonwealth Ave., #800
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Composite Abuse Scale (CAS)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Validated 30-item research instrument that assesses exposure to physical, sexual and emotional abuse, harassment and combined severe abuse.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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The Domestic Violence Survivor Assessment (DVSA)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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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.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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PRIME-MD Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Depression measure.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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SPAN (Startle, Physiological arousal, Anger and Numbness)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Post-Traumatic Stress Disorder measure.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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The SF-12 (v. 2)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Mental and Physical Health
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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The TWEAK
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Screening tool for alcohol abuse/dependency.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Drug Abuse Screening Tool (DAST)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Prescription and Street Drug Use.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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The Intimate Partner Violence Strategies Index (IPV Strategies)
Time Frame: Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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Specific actions women take to cope with violence.
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Baseline, 3-, 6-,12-, 18-, and 24-month postpartum
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The Childhood Experiences of Violence Questionnaire Short Form (CEVQ-SF)
Time Frame: 6-month postpartum
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Childhood maltreatment
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6-month postpartum
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The Childhood Trauma Questionnaire (CTQ)
Time Frame: 6-month postpartum
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Childhood maltreatment.
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6-month postpartum
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A modified version of the Health and Social Service Utilization questionnaire
Time Frame: 6-,12-, 18-, and 24-month postpartum
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Assessment of service utilization.
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6-,12-, 18-, and 24-month postpartum
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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
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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.
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Outcomes 1 and 2 are assessed at infant birth, 3 to 7 will be assessed at 6-, 12-, 18-, 24-month postpartum
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Child Protection Service records
Time Frame: 24-month postpartum
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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.
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24-month postpartum
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The Public Health Nurses' Responses to Women Who Are Abused
Time Frame: Collected from nurses at baseline, 12 and 24 months
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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.
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Collected from nurses at baseline, 12 and 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harriet MacMillan, MD, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
May 1, 2015
Study Registration Dates
First Submitted
June 9, 2011
First Submitted That Met QC Criteria
June 10, 2011
First Posted (ESTIMATE)
June 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 9, 2015
Last Update Submitted That Met QC Criteria
June 8, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MacMillan_NFP_IPVI_RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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