Clinical trial NCT01672060: BC Healthy Connections Project
Official title: A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness of Nurse-Family Partnership (NFP) in BC
Lead sponsor: Simon Fraser University
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Ministry of Health, British Columbia
name: Ministry of Children and Family Development, British Columbia
name: University of British Columbia
name: University of Victoria
name: Public Health Agency of Canada (PHAC)
First posted: 2012-08-24
Enrollment: 739
Sex: FEMALE
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Average number of childhood injuries
timeFrame: 2, 10, 18 and 24 months postpartum
Secondary outcomes:
measure: Prenatal substance use
timeFrame: Baseline (before 28 weeks gestation), 34-36 weeks gestation
measure: Child development
timeFrame: 24 months postpartum
measure: Child mental health
timeFrame: 24 months postpartum
measure: Maternal life course
timeFrame: 2, 10, 18 and 24 months postpartum
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
state: British Columbia
Study officials:
affiliation: Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
name: Charlotte Waddell, MSc, MD, CCFP, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Catherine NLA, Boyle M, Zheng Y, McCandless L, Xie H, Lever R, Sheehan D, Gonzalez A, Jack SM, Gafni A, Tonmyr L, Marcellus L, Varcoe C, Cullen A, Hjertaas K, Riebe C, Rikert N, Sunthoram A, Barr R, MacMillan H, Waddell C. Nurse home visiting and prenatal substance use in a socioeconomically disadvantaged population in British Columbia: analysis of prenatal secondary outcomes in an ongoing randomized controlled trial. CMAJ Open. 2020 Oct 27;8(4):E667-E675. doi: 10.9778/cmajo.20200063. Print 2020 Oct-Dec.
citation: Catherine NLA, Lever R, Marcellus L, Tallon C, Sheehan D, MacMillan H, Gonzalez A, Jack SM, Waddell C. Retaining participants in community-based health research: a case example on standardized planning and reporting. Trials. 2020 May 11;21(1):393. doi: 10.1186/s13063-020-04328-9.
citation: Catherine NLA, Lever R, Sheehan D, Zheng Y, Boyle MH, McCandless L, Gafni A, Gonzalez A, Jack SM, Tonmyr L, Varcoe C, MacMillan HL, Waddell C; British Columbia Healthy Connections Project Scientific Team. The British Columbia Healthy Connections Project: findings on socioeconomic disadvantage in early pregnancy. BMC Public Health. 2019 Aug 22;19(1):1161. doi: 10.1186/s12889-019-7479-5.
citation: Gonzalez A, Catherine N, Boyle M, Jack SM, Atkinson L, Kobor M, Sheehan D, Tonmyr L, Waddell C, MacMillan HL; Healthy Foundations Study Team. Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences. BMJ Open. 2018 Jan 26;8(1):e018915. doi: 10.1136/bmjopen-2017-018915.
citation: Catherine NL, Gonzalez A, Boyle M, Sheehan D, Jack SM, Hougham KA, McCandless L, MacMillan HL, Waddell C; British Columbia Healthy Connections Project Scientific Team. Improving children's health and development in British Columbia through nurse home visiting: a randomized controlled trial protocol. BMC Health Serv Res. 2016 Aug 4;16(a):349. doi: 10.1186/s12913-016-1594-0.