Effectiveness of Nurse-Family Partnership (NFP) in BCBCHCPNCT01672060
BC Healthy Connections Project
A study testing Nurse-Family Partnership (NFP) and Existing services in people with Effectiveness of Nurse-Family Partnership (NFP) in BC, run by Simon Fraser University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 24 years, women only
- Conditions the study is for
- Effectiveness of Nurse-Family Partnership (NFP) in BC
- What is being tested?
- Nurse-Family Partnership (NFP) and Existing services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2013to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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):
Show all 12Show fewer
- 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)?
Who cannot join
- Planning to have the child adopted
- Planning to leave the NFP catchment area (for three months or longer)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
Vancouver, British Columbia, V6B 5K3
About this study
Official title: 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.
- Being tested
- Nurse-Family Partnership (NFP), Existing services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Family Partnership (NFP)Behavioural
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 servicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Family Partnership (NFP) | Experimental | Not described Receives: Behavioral: Nurse-Family Partnership (NFP) |
| Existing services | Active comparator | Not described Receives: Behavioral: Existing services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2, 10, 18 and 24 months postpartum
Secondary outcomes (4)
Prenatal substance use
Tobacco and alcohol use
Measured: Baseline (before 28 weeks gestation), 34-36 weeks gestation
Child development
Cognitive ability and language development
Measured: 24 months postpartum
Child mental health
Behaviour problems
Measured: 24 months postpartum
Maternal life course
Number of subsequent pregnancies by 24 months postpartum
Measured: 2, 10, 18 and 24 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study start15 Oct 2013
- Primary completionDec 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Effectiveness of Nurse-Family Partnership (NFP) in BCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Fraser University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Ministry of Health, British Columbia, Ministry of Children and Family Development, British Columbia, University of British Columbia, University of Victoria, Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Dr. Charlotte Waddell, Simon Fraser University
- Investigators
- Charlotte Waddell, MSc, MD, CCFP, FRCPC, Principal investigator, Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672060
- Sponsor's protocol ID
- 2010s0569
- Acronym
- BCHCP
- Status last verified
- May 2022
- First submitted
- 21 Aug 2012
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Catherine NLA, Zheng Y, Xie H, Boyle M, Jack SM, MacMillan H, Waddell C. Effectiveness of Nurse-Family Partnership on child outcomes by patterns of program intensity: Secondary evidence from a randomized controlled trial (British Columbia Healthy Connections Project). Child Abuse Negl. 2025 Sep;167:107600. doi: 10.1016/j.chiabu.2025.107600. Epub 2025 Jul 24.
PubMed 40712198Catherine NLA, MacMillan H, Jack S, Zheng Y, Xie H, Boyle M, Sheehan D, Gonzalez A, Gafni A, Tonmyr L, Barr R, Marcellus L, Varcoe C, Waddell C. Effects of nurse-home visiting on intimate partner violence and maternal income, mental health and self-efficacy by 24 months postpartum: a randomised controlled trial (British Columbia Healthy Connections Project). BMJ Open. 2025 Jan 6;15(1):e083147. doi: 10.1136/bmjopen-2023-083147.
PubMed 39762105Catherine NLA, MacMillan H, Cullen A, Zheng Y, Xie H, Boyle M, Sheehan D, Lever R, Jack SM, Gonzalez A, Gafni A, Tonmyr L, Barr R, Marcellus L, Varcoe C, Waddell C. Effectiveness of nurse-home visiting in improving child and maternal outcomes prenatally to age two years: a randomised controlled trial (British Columbia Healthy Connections Project). J Child Psychol Psychiatry. 2024 May;65(5):644-655. doi: 10.1111/jcpp.13846. Epub 2023 Jul 19.
PubMed 37464862Catherine 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.
PubMed 33109532Catherine 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.
PubMed 32393334Catherine 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.
PubMed 31438906Gonzalez 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.
PubMed 29374668Catherine 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.
PubMed 27488474
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia
- ClinicalTrials.gov ID
- NCT01672060
- Acronym / sponsor ID
- BCHCP / 2010s0569
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Simon Fraser UniversityUniversity, hospital or other
- Collaborators
- McMaster University, Ministry of Health, British Columbia, Ministry of Children and Family Development, British Columbia, University of British Columbia, University of Victoria, Public Health Agency of Canada (PHAC)
- Study start
- 15 Oct 2013 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-Family Partnership (NFP) | Experimental | Behavioral: Nurse-Family Partnership (NFP) |
| Existing services | Active comparator | Behavioral: Existing services |
Who may qualify
- Ages
- Up to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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):
Key exclusion criteria (2 listed)
- Planning to have the child adopted
- Planning to leave the NFP catchment area (for three months or longer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Nurse-Family Partnership (NFP) |
| Existing servicesParticipants 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. | Behavioural | Existing services |
Primary outcome
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
4 secondary outcomes
Prenatal substance use
Time frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation
Child development
Time frame: 24 months postpartum
Child mental health
Time frame: 24 months postpartum
Maternal life course
Time frame: 2, 10, 18 and 24 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 40712198Catherine NLA, Zheng Y, Xie H, Boyle M, Jack SM, MacMillan H, Waddell C. Effectiveness of Nurse-Family Partnership on child outcomes by patterns of program intensity: Secondary evidence from a randomized controlled trial (British Columbia Healthy Connections Project). Child Abuse Negl. 2025 Sep;167:107600. doi: 10.1016/j.chiabu.2025.107600. Epub 2025 Jul 24.
- Derived from this study: PubMed 39762105Catherine NLA, MacMillan H, Jack S, Zheng Y, Xie H, Boyle M, Sheehan D, Gonzalez A, Gafni A, Tonmyr L, Barr R, Marcellus L, Varcoe C, Waddell C. Effects of nurse-home visiting on intimate partner violence and maternal income, mental health and self-efficacy by 24 months postpartum: a randomised controlled trial (British Columbia Healthy Connections Project). BMJ Open. 2025 Jan 6;15(1):e083147. doi: 10.1136/bmjopen-2023-083147.
- Derived from this study: PubMed 37464862Catherine NLA, MacMillan H, Cullen A, Zheng Y, Xie H, Boyle M, Sheehan D, Lever R, Jack SM, Gonzalez A, Gafni A, Tonmyr L, Barr R, Marcellus L, Varcoe C, Waddell C. Effectiveness of nurse-home visiting in improving child and maternal outcomes prenatally to age two years: a randomised controlled trial (British Columbia Healthy Connections Project). J Child Psychol Psychiatry. 2024 May;65(5):644-655. doi: 10.1111/jcpp.13846. Epub 2023 Jul 19.
- Derived from this study: PubMed 33109532Catherine 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.
- Derived from this study: PubMed 32393334Catherine 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.
- Derived from this study: PubMed 31438906Catherine 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.
- Derived from this study: PubMed 29374668Gonzalez 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.
- Derived from this study: PubMed 27488474Catherine 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Waddell, MSc, MD, CCFP, FRCPC principal investigator
Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Family Partnership (NFP) and Existing services in people with Effectiveness of Nurse-Family Partnership (NFP) in BC, run by Simon Fraser University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of childhood injuries (time frame: 2, 10, 18 and 24 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672060, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.