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Completed

NCT Number: NCT01672060

BC Healthy Connections Project

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.

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Key information

Conditions

Effectiveness of Nurse-Family Partnership (NFP) in BC

Age range

Up to 24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University

Vancouver, British Columbia, V6B 5K3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 24 years or under
  • First Birth
  • Less than 27 weeks gestation
  • Competent to provide informed consent, including conversational competence in English
  • 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

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

Treatment and study plan

Nurse-Family Partnership (NFP)

Behavioral

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.

Existing services

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Prenatal substance use

    Time frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation

    Tobacco and alcohol use

  2. Child development

    Time frame: 24 months postpartum

    Cognitive ability and language development

  3. Child mental health

    Time frame: 24 months postpartum

    Behaviour problems

  4. Maternal life course

    Time frame: 2, 10, 18 and 24 months postpartum

    Number of subsequent pregnancies by 24 months postpartum

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Collaborators

  • McMaster University
  • Ministry of Children and Family Development, British Columbia
  • Ministry of Health, British Columbia
  • Public Health Agency of Canada (PHAC)
  • University of British Columbia
  • University of Victoria

Registry information

Official study title

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

Acronym: BCHCP

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Aug 24, 2012
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.