BC Healthy Connections Project (BCHCP)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01672060 |
Recruitment Status :
Active, not recruiting
First Posted : August 24, 2012
Last Update Posted : January 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Effectiveness of Nurse-Family Partnership (NFP) in BC | Behavioral: Nurse-Family Partnership (NFP) Behavioral: Existing services | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 739 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia |
Actual Study Start Date : | October 15, 2013 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
---|---|
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. |
- 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
- Prenatal substance use [ Time Frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation ]Tobacco and alcohol use
- Child development [ Time Frame: 24 months postpartum ]Cognitive ability and language development
- Child mental health [ Time Frame: 24 months postpartum ]Behaviour problems
- Maternal life course [ Time Frame: 2, 10, 18 and 24 months postpartum ]Number of subsequent pregnancies by 24 months postpartum

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Ages Eligible for Study: | up to 24 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672060
Canada, British Columbia | |
Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University | |
Vancouver, British Columbia, Canada, V6B 5K3 |
Principal Investigator: | Charlotte Waddell, MSc, MD, CCFP, FRCPC | Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Charlotte Waddell, University Professor, Simon Fraser University |
ClinicalTrials.gov Identifier: | NCT01672060 |
Other Study ID Numbers: |
2010s0569 |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | January 3, 2020 |
Last Verified: | January 2020 |