- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01672060
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
Status
Completed
Intervention / Treatment
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
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British Columbia
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Vancouver, British Columbia, Canada, V6B 5K3
- Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
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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:
- 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)
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)
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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.
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Active Comparator: Existing services
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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.
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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
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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
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2, 10, 18 and 24 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prenatal substance use
Time Frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation
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Tobacco and alcohol use
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Baseline (before 28 weeks gestation), 34-36 weeks gestation
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Child development
Time Frame: 24 months postpartum
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Cognitive ability and language development
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24 months postpartum
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Child mental health
Time Frame: 24 months postpartum
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Behaviour problems
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24 months postpartum
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Maternal life course
Time Frame: 2, 10, 18 and 24 months postpartum
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Number of subsequent pregnancies by 24 months postpartum
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2, 10, 18 and 24 months postpartum
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- 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. Erratum In: CMAJ Open. 2021 Nov 23;9(4):E1040.
- 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.
- 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.
- 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.
- 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.
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.
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