BC Healthy Connections Project

Effectiveness of Nurse-Family Partnership (NFP) in BC Clinical Trial

— BCHCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672060
• Other study ID #: 2010s0569
• Status: Completed
• Phase: N/A
• Start date: October 15, 2013
• Est. completion date: March 2022

Study information

• Verified date: May 2022
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Effectiveness of Nurse-Family Partnership (NFP) in BC

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Simon Fraser University	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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average number of childhood injuries	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	Prenatal substance use	Tobacco and alcohol use	Baseline (before 28 weeks gestation), 34-36 weeks gestation
Secondary	Child development	Cognitive ability and language development	24 months postpartum
Secondary	Child mental health	Behaviour problems	24 months postpartum
Secondary	Maternal life course	Number of subsequent pregnancies by 24 months postpartum	2, 10, 18 and 24 months postpartum

External Links

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