<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672060</url>
  </required_header>
  <id_info>
    <org_study_id>2010s0569</org_study_id>
    <nct_id>NCT01672060</nct_id>
  </id_info>
  <brief_title>BC Healthy Connections Project</brief_title>
  <acronym>BCHCP</acronym>
  <official_title>A Scientific Evaluation of the Nurse-Family Partnership (NFP) Program in British Columbia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Simon Fraser University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Children and Family Development, British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Agency of Canada (PHAC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Simon Fraser University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nurse-Family Partnership (NFP) is a primary prevention program that was developed by Dr.&#xD;
      David Olds in the United States (US) with the goal of helping vulnerable young first-time&#xD;
      mothers and their children. The program involves public health nurses (PHNs) visiting mothers&#xD;
      in their homes, providing intensive supports starting in pregnancy and continuing until&#xD;
      children reach their second birthday. Studies in the US have shown that NFP significantly&#xD;
      reduces child maltreatment and child behaviour problems, while also improving children's&#xD;
      early learning and mother's economic self-sufficiency. Economic studies have also shown that&#xD;
      the program pays for itself over the long-term. However, NFP has never been tested in Canada.&#xD;
      Due to major differences in our populations and in our public services, we do not know&#xD;
      whether NFP will show the same benefits here. We therefore plan to conduct a scientific&#xD;
      evaluation of NFP's effectiveness in British Columbia (BC), in close collaboration with the&#xD;
      BC government and BC's Health Authorities. Using randomized-controlled trial methods, NFP's&#xD;
      effectiveness will be specifically evaluated in comparison with existing perinatal services&#xD;
      in BC regarding outcomes across three fundamental domains: 1) pregnancy and birth; 2) child&#xD;
      health and development; and 3) maternal health and life course. Findings from this evaluation&#xD;
      will be used to improve the NFP program - to better meet the needs of vulnerable young&#xD;
      mothers and their children in BC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2013</start_date>
  <completion_date type="Actual">March 2022</completion_date>
  <primary_completion_date type="Actual">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average number of childhood injuries</measure>
    <time_frame>2, 10, 18 and 24 months postpartum</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prenatal substance use</measure>
    <time_frame>Baseline (before 28 weeks gestation), 34-36 weeks gestation</time_frame>
    <description>Tobacco and alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child development</measure>
    <time_frame>24 months postpartum</time_frame>
    <description>Cognitive ability and language development</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child mental health</measure>
    <time_frame>24 months postpartum</time_frame>
    <description>Behaviour problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal life course</measure>
    <time_frame>2, 10, 18 and 24 months postpartum</time_frame>
    <description>Number of subsequent pregnancies by 24 months postpartum</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">739</enrollment>
  <condition>Effectiveness of Nurse-Family Partnership (NFP) in BC</condition>
  <arm_group>
    <arm_group_label>Nurse-Family Partnership (NFP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing services</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nurse-Family Partnership (NFP)</intervention_name>
    <description>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.</description>
    <arm_group_label>Nurse-Family Partnership (NFP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Existing services</intervention_name>
    <description>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.</description>
    <arm_group_label>Existing services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 24 years or under&#xD;
&#xD;
          2. First Birth&#xD;
&#xD;
          3. Less than 27 weeks gestation&#xD;
&#xD;
          4. Competent to provide informed consent, including conversational competence in English&#xD;
&#xD;
          5. Experiencing socioeconomic disadvantage (must meet 5a or 5b):&#xD;
&#xD;
        5a. Aged 19 years or younger (eligible) 5b. Aged 20-24 (eligible if has TWO of the&#xD;
        following):&#xD;
&#xD;
          -  5.1. Lone parent (is not married or living common-law, i.e., not living with the same&#xD;
             person for more than one year)&#xD;
&#xD;
          -  5.2. Less than grade 12 (does not have BC's Dogwood certificate, General Education&#xD;
             Development [GED] Credential or other diploma equivalent to grade 12; note that the&#xD;
             Evergreen Certificate is not equivalent to grade 12)&#xD;
&#xD;
          -  5.3. Low income (based on answering &quot;yes&quot; to any ONE of the following)&#xD;
&#xD;
          -  5.3a. Do you receive income assistance (e.g., disability, social assistance,&#xD;
             employment insurance, or BC Medical Services Plan Premium Assistance)?&#xD;
&#xD;
          -  5.3b. Do you find it very difficult to live on your total household income,&#xD;
             particularly regarding food and rent?&#xD;
&#xD;
          -  5.3c. Do you live in a group home, shelter, or institutional facility (e.g., treatment&#xD;
             center)?&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planning to have the child adopted&#xD;
&#xD;
          2. Planning to leave the NFP catchment area (for three months or longer)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charlotte Waddell, MSc, MD, CCFP, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6B 5K3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://childhealthpolicy.ca/bc-healthy-connections-project/</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Simon Fraser University</investigator_affiliation>
    <investigator_full_name>Dr. Charlotte Waddell</investigator_full_name>
    <investigator_title>University Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672060
org study id: 2010s0569
nct id: NCT01672060
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Average number of childhood injuries
time frame: 2, 10, 18 and 24 months postpartum
description: 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
measure: Prenatal substance use
time frame: Baseline (before 28 weeks gestation), 34-36 weeks gestation
description: Tobacco and alcohol use
measure: Child development
time frame: 24 months postpartum
description: Cognitive ability and language development
measure: Child mental health
time frame: 24 months postpartum
description: Behaviour problems
measure: Maternal life course
time frame: 2, 10, 18 and 24 months postpartum
description: Number of subsequent pregnancies by 24 months postpartum
arm group label: Nurse-Family Partnership (NFP)
arm group type: Experimental
arm group label: Existing services
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Nurse-Family Partnership (NFP)
description: 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.
arm group label: Nurse-Family Partnership (NFP)
intervention type: Behavioral
intervention name: Existing services
description: 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.
arm group label: Existing services
criteria: 
gender: Female
minimum age: N/A
maximum age: 24 Years
healthy volunteers: No
last name: Charlotte Waddell, MSc, MD, CCFP, FRCPC
role: Principal Investigator
affiliation: Director, Children's Health Policy Centre, Faculty of Health Sciences, Simon Fraser University
facility: 
country: Canada
url: http://childhealthpolicy.ca/bc-healthy-connections-project/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Simon Fraser University
investigator full name: Dr. Charlotte Waddell
investigator title: University Professor