BC Healthy Connections Project (BCHCP)

May 3, 2022 updated by: Dr. Charlotte Waddell, Simon Fraser University

A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia

Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr. David Olds in the United States (US) with the goal of helping vulnerable young first-time mothers and their children. The program involves public health nurses (PHNs) visiting mothers in their homes, providing intensive supports starting in pregnancy and continuing until children reach their second birthday. Studies in the US have shown that NFP significantly reduces child maltreatment and child behaviour problems, while also improving children's early learning and mother's economic self-sufficiency. Economic studies have also shown that the program pays for itself over the long-term. However, NFP has never been tested in Canada. Due to major differences in our populations and in our public services, we do not know whether NFP will show the same benefits here. We therefore plan to conduct a scientific evaluation of NFP's effectiveness in British Columbia (BC), in close collaboration with the BC government and BC's Health Authorities. Using randomized-controlled trial methods, NFP's effectiveness will be specifically evaluated in comparison with existing perinatal services in BC regarding outcomes across three fundamental domains: 1) pregnancy and birth; 2) child health and development; and 3) maternal health and life course. Findings from this evaluation will be used to improve the NFP program - to better meet the needs of vulnerable young mothers and their children in BC.

Study Overview

Study Type

Interventional

Enrollment (Actual)

739

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

    • British Columbia
      • Vancouver, British Columbia, Canada, V6B 5K3
        • Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University

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

No older than 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Aged 24 years or under
  2. First Birth
  3. Less than 27 weeks gestation
  4. Competent to provide informed consent, including conversational competence in English
  5. Experiencing socioeconomic disadvantage (must meet 5a or 5b):

5a. Aged 19 years or younger (eligible) 5b. Aged 20-24 (eligible if has TWO of the following):

  • 5.1. Lone parent (is not married or living common-law, i.e., not living with the same person for more than one year)
  • 5.2. Less than grade 12 (does not have BC's Dogwood certificate, General Education Development [GED] Credential or other diploma equivalent to grade 12; note that the Evergreen Certificate is not equivalent to grade 12)
  • 5.3. Low income (based on answering "yes" to any ONE of the following)
  • 5.3a. Do you receive income assistance (e.g., disability, social assistance, employment insurance, or BC Medical Services Plan Premium Assistance)?
  • 5.3b. Do you find it very difficult to live on your total household income, particularly regarding food and rent?
  • 5.3c. Do you live in a group home, shelter, or institutional facility (e.g., treatment center)?

Exclusion Criteria:

  1. Planning to have the child adopted
  2. Planning to leave the NFP catchment area (for three months or longer)

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-Family Partnership (NFP)
Trained Public Health Nurses (PHNs) will deliver Nurse-Family Partnership (NFP) using specified pregnancy, infancy and toddler curricula. Following enrollment in the study, NFP PHNs will provide regular home visits to participants throughout the remainder of the participant's pregnancy, continuing through until the child's second birthday. In addition to offering standard care during each visit, PHNs will deliver NFP content using program materials relevant to the following domains: personal health, maternal role, environmental health, family and friends, life course development, and health and human services.
Active Comparator: Existing services
Participants allocated to the comparison group will receive all the usual perinatal programs and services offered within their Health Authority, including primary care and specialist physician services covered under BC's public healthcare system. These services vary across the province but may include: standard primary healthcare services; public health programs including prenatal classes, pregnancy outreach and home visiting by nurses or paraprofessionals; and a variety of targeted and universal parenting and early child development programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average number of childhood injuries
Time Frame: 2, 10, 18 and 24 months postpartum
The average number of physician/health care provider encounters per child for injuries (intentional or unintentional), measured in community/outpatient, emergency room (ER) and hospital settings, from birth through 24 months postpartum
2, 10, 18 and 24 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal substance use
Time Frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation
Tobacco and alcohol use
Baseline (before 28 weeks gestation), 34-36 weeks gestation
Child development
Time Frame: 24 months postpartum
Cognitive ability and language development
24 months postpartum
Child mental health
Time Frame: 24 months postpartum
Behaviour problems
24 months postpartum
Maternal life course
Time Frame: 2, 10, 18 and 24 months postpartum
Number of subsequent pregnancies by 24 months postpartum
2, 10, 18 and 24 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charlotte Waddell, MSc, MD, CCFP, FRCPC, Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser 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

Helpful Links

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 (Actual)

October 15, 2013

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 24, 2012

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2010s0569

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.

Clinical Trials on Nurse-Family Partnership (NFP)

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