BC Healthy Connections Project (BCHCP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Simon Fraser University
Sponsor:
Collaborators:
McMaster University
Ministry of Health, British Columbia
Ministry of Children and Family Development, British Columbia
Information provided by (Responsible Party):
Dr. Charlotte Waddell, Simon Fraser University
ClinicalTrials.gov Identifier:
NCT01672060
First received: August 21, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Effectiveness of Nurse-Family Partnership (NFP) in BC
Behavioral: Nurse-Family Partnership (NFP)
Behavioral: Existing services

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia

Resource links provided by NLM:


Further study details as provided by Simon Fraser University:

Primary Outcome Measures:
  • Average number of childhood injuries [ Time Frame: 2, 10, 18 and 24 months postpartum ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Prenatal substance use [ Time Frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation ] [ Designated as safety issue: No ]
    Tobacco and alcohol use

  • Child development [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
    Cognitive ability and language development

  • Child mental health [ Time Frame: 24 months postpartum ] [ Designated as safety issue: No ]
    Behaviour problems

  • Maternal life course [ Time Frame: 2, 10, 18 and 24 months postpartum ] [ Designated as safety issue: No ]
    Number of subsequent pregnancies by 24 months postpartum


Estimated Enrollment: 1040
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nurse-Family Partnership (NFP) Behavioral: 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 Behavioral: 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.

  Eligibility

Ages Eligible for Study:   up to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672060

Contacts
Contact: Nicole Catherine, MSc, PhD 778-782-7669 nicole_catherine@sfu.ca

Locations
Canada, British Columbia
Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University Recruiting
Vancouver, British Columbia, Canada, V6B 5K3
Contact: Nicole Catherine, MSc, PhD.    778-782-7669    nicole_catherine@sfu.ca   
Principal Investigator: Charlotte Waddell, MSc, MD, CCFP, FRCPC         
Sponsors and Collaborators
Simon Fraser University
McMaster University
Ministry of Health, British Columbia
Ministry of Children and Family Development, British Columbia
Investigators
Principal Investigator: Charlotte Waddell, MSc, MD, CCFP, FRCPC Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Charlotte Waddell, Associate Professor and Canada Research Chair (CRC) in Children's Health Policy, Director Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University, Simon Fraser University
ClinicalTrials.gov Identifier: NCT01672060     History of Changes
Other Study ID Numbers: 2010s0569
Study First Received: August 21, 2012
Last Updated: January 22, 2014
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 28, 2014