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).

BACKGROUND: We investigated the effectiveness of Nurse-Family Partnership (NFP), a prenatal-to-age-two-years home-visiting programme, in British Columbia (BC), Canada. METHODS: For this randomised controlled trial, we recruited participants from 26 public health settings who were: <25 years, nulliparous, <28 weeks gestation and experiencing socioeconomic disadvantage. We randomly allocated participants (one-to-one; computer-generated) to intervention (NFP plus existing services) or comparison (existing services) groups. Prespecified outcomes were prenatal substance exposure (reported previously); child injuries (primary), language, cognition and mental health (problem behaviour) by age two years; and subsequent pregnancies by 24 months postpartum. Research interviewers were masked. We used intention-to-treat analyses. (ClinicalTrials.gov, NCT01672060.) RESULTS: From 2013 to 2016 we enrolled 739 participants (368 NFP, 371 comparison) who had 737 children. Counts for child injury healthcare encounters [rate per 1,000 person-years or RPY] were similar for NFP (223 [RPY 316.17]) and comparison (223 [RPY 305.43]; rate difference 10.74, 95% CI -46.96, 68.44; rate ratio 1.03, 95% CI 0.78, 1.38). Maternal-reported language scores (mean, M [SD]) were statistically significantly higher for NFP (313.46 [195.96]) than comparison (282.77 [188.15]; mean difference [MD] 31.33, 95% CI 0.96, 61.71). Maternal-reported problem-behaviour scores (M [SD]) were statistically significantly lower for NFP (52.18 [9.19]) than comparison (54.42 [9.02]; MD -2.19, 95% CI -3.62, -0.75). Subsequent pregnancy counts were similar (NFP 115 [RPY 230.69] and comparison 117 [RPY 227.29]; rate difference 3.40, 95% CI -55.54, 62.34; hazard ratio 1.01, 95% CI 0.79, 1.29). We observed no unanticipated adverse events. CONCLUSIONS: NFP did not reduce child injuries or subsequent maternal pregnancies but did improve maternal-reported child language and mental health (problem behaviour) at age two years. Follow-up of long-term outcomes is warranted given that further benefits may emerge across childhood and adolescence.

Public Health Nurses' Professional Practices to Prevent, Recognize, and Respond to Suspected Child Maltreatment in Home Visiting: An Interpretive Descriptive Study.

The purpose of this analysis was to understand public health nurses' experiences in preventing and addressing suspected child maltreatment within the context of home visiting. The principles of interpretive description guided study decisions and data were generated from interviews with 47 public health nurses. Data were analyzed using reflexive thematic analysis. The findings highlighted that public health nurses have an important role in the primary prevention of child maltreatment. These nurses described a six-step process for managing their duty to report suspected child maltreatment within the context of nurse-client relationships. When indicators of suspected child maltreatment were present, examination of experiential practice revealed that nurses developed reporting processes that maximized child safety, highlighted maternal strengths, and created opportunities to maintain the nurse-client relationship. Even with child protection involvement, public health nurses have a central role in continuing to work with families to develop safe and competent parenting skills.

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.

BACKGROUND: Nurse-Family Partnership (NFP) involves public health nurses providing frequent home visits from early pregnancy until children reach age 2 years, focusing on first-time parents experiencing socioeconomic disadvantage. Our aim was to evaluate NFP's effectiveness in improving child and maternal health. METHODS: We conducted an analysis of prenatal secondary outcomes in an ongoing randomized controlled trial in British Columbia; the data used in this analysis were collected from January 2014 to May 2017. Participants were pregnant girls and women aged 14-24 years who were preparing to parent for the first time and experiencing socioeconomic disadvantage. They were randomly allocated 1:1 to the intervention (NFP plus existing services) or control group (existing services). Prespecified prenatal secondary outcome indicators were changes in use of nicotine cigarettes and alcohol use by 34-36-weeks' gestation. We also report on prespecified exploratory cannabis and street drug use measures. We used mixed-effect models for longitudinal and clustered data to estimate intervention effects. Analyses were by intention to treat. RESULTS: The median gestational age at baseline for the 739 participants (368 participants in the intervention group, 371 in the comparison group) was 20 weeks, 6 days. By 34-36 weeks' gestation, NFP significantly reduced cigarette counts (over the past 2 d) (difference in changes [DIC] of count -1.6, 95% confidence interval [CI] -6.4 to -1.3) in those who smoked. NFP also significantly reduced rates of prenatal cannabis use (DIC -6.4, 95% CI -17.0 to -1.7), but not rates of street drug or "any" substance use. While we observed decreased rates of cigarette and alcohol use in both groups (DIC of proportions -2.8, 95% CI -15.3 to 0.6; DIC -0.5, 95% CI -8.7 to 1.8, respectively), these changes were not statistically significant. INTERPRETATION: We found no evidence that NFP was effective in reducing rates of prenatal cigarette and alcohol use; however, it led to reduced prenatal cannabis use, and in smokers it led to modest reductions in cigarette use. NFP may therefore hold promise for reducing some types of prenatal substance use in disadvantaged populations. Trial registration: ClinicalTrials.gov, no. NCT01672060.

Retaining participants in community-based health research: a case example on standardized planning and reporting.

BACKGROUND: Effective strategies for participant retention are critical in health research to ensure validity, generalizability and efficient use of resources. Yet standardized guidelines for planning and reporting on retention efforts have been lacking. As with randomized controlled trial (RCT) and systematic review (SR) protocols, retention protocols are an opportunity to improve transparency and rigor. An RCT being conducted in British Columbia (BC), Canada provides a case example for developing a priori retention frameworks for use in protocol planning and reporting. METHODS: The BC Healthy Connections Project RCT is examining the effectiveness of a nurse home-visiting program in improving child and maternal outcomes compared with existing services. Participants (N = 739) were girls and young women preparing to parent for the first time and experiencing socioeconomic disadvantage. Quantitative data were collected upon trial entry during pregnancy and during five follow-up interviews until participants' children reached age 2 years. A framework was developed to guide retention of this study population throughout the RCT. We reviewed relevant literature and mapped essential retention activities across the study planning, recruitment and maintenance phases. Interview completion rates were tracked. RESULTS: Results from 3302 follow-up interviews (in-person/telephone) conducted over 4 years indicate high completion rates: 90% (n = 667) at 34 weeks gestation; and 91% (n = 676), 85% (n = 626), 80% (n = 594) and 83% (n = 613) at 2, 10, 18 and 24 months postpartum, respectively. Almost all participants (99%, n = 732) provided ongoing consent to access administrative health data. These results provide preliminary data on the success of the framework. CONCLUSIONS: Our retention results are encouraging given that participants were experiencing considerable socioeconomic disadvantage. Standardized retention planning and reporting may therefore be feasible for health research in general, using the framework we have developed. Use of standardized retention protocols should be encouraged in research to promote consistency across diverse studies, as now happens with RCT and SR protocols. Beyond this, successful retention approaches may help inform health policy-makers and practitioners who also need to better reach, engage and retain underserved populations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01672060. Registered on 24 August 2012.

The British Columbia Healthy Connections Project: findings on socioeconomic disadvantage in early pregnancy.

BACKGROUND: Maternal exposure to socioeconomic disadvantage increases the risk of child injuries and subsequent child developmental and mental health problems - particularly for young mothers. To inform early intervention planning, this research therefore aimed to describe the health and social adversities experienced by a cohort of girls and young women in early pregnancy in British Columbia (BC), Canada. METHODS: Participants were recruited for the BC Healthy Connections Project (BCHCP), a randomized controlled trial examining the effectiveness of Nurse-Family Partnership, a home visitation program, in improving child and maternal outcomes. Baseline data were collected from 739 participants on trial entry. Participants were selected on the basis of preparing to parent for the first time and experiencing socioeconomic disadvantage. Analyses involved descriptive statistics and age-group comparisons. RESULTS: Most participants reported having low income (84%), having limited education (52%) and being single (91%) at trial entry. Beyond these eligibility criteria, other health and social adversities included: housing instability (52%); severe anxiety or depression (47%); other diagnosed mental disorders (22%); prenatal nicotine and cannabis use (27 and 21%); physical health problems (20%); child maltreatment when younger (56%); and intimate partner violence recently (50%). As well, few (29%) had received income assistance entitlements. More than two thirds (70%) were experiencing four or more forms of adversity. Age-group differences were observed for cognitive functioning, being single, low income, limited education, psychological distress and service use (p-value ≤0.05). CONCLUSIONS: This cohort was selected on the basis of socioeconomic disadvantage. Yet all participants were experiencing substantial added adversities - at higher rates than other Canadians. Furthermore, despite Canada's public programs, these pregnant girls and young women were not being adequately reached by social services. Our study adds new data to inform early intervention planning, suggesting that unacceptably high levels of socioeconomic disadvantage exist for some young British Columbians. Therefore greater health and social supports and services are warranted for these young mothers and their children. TRIAL REGISTRATION: Registered August 24, 2012 with ClinicalTrials.gov Identifier: NCT01672060 . Active not recruiting.

Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences.

INTRODUCTION: Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants. METHODS AND ANALYSIS: Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years. ETHICS AND DISSEMINATION: The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions. TRIAL REGISTRATION NUMBER: NCT01672060; Pre-results.

Improving children's health and development in British Columbia through nurse home visiting: a randomized controlled trial protocol.

BACKGROUND: Nurse-Family Partnership is a nurse home visitation program that aims to improve the lives of young mothers and their children. The program focuses on women who are parenting for the first time and experiencing socioeconomic disadvantage. Nurse visits start as early in pregnancy as possible and continue until the child reaches age two years. The program has proven effective in the United States - improving children's mental health and development and maternal wellbeing, and showing long-term cost-effectiveness. But it is not known whether the same benefits will be obtained in Canada, where public services differ. The British Columbia Healthy Connections Project therefore involves a randomized controlled trial evaluating Nurse-Family Partnership's effectiveness compared with existing (usual) services in improving children's mental health and early development and mother's life circumstances. The trial's main aims are to: reduce childhood injuries by age two years (primary outcome indicator); reduce prenatal nicotine and alcohol use; improve child cognitive and language development and behaviour at age two years; and reduce subsequent pregnancies by 24 months postpartum. Potential explanatory factors such as maternal mental health (including self-efficacy) are also being assessed, as is the program's impact on exposure to intimate-partner violence. To inform future economic evaluation, data are also being collected on health and social service access and use. METHODS/DESIGN: Eligible and consenting participants (N = 1040) are being recruited prior to 28 weeks gestation then individually randomized to receive existing services (comparison group) or Nurse-Family Partnership plus existing services (intervention group). Nurse-Family Partnership is being delivered following fidelity guidelines. Data are being collected during in person and telephone interviews at: baseline; 34-36 weeks gestation; and two, 10, 18 and 24 months postpartum. Additional data will be obtained via linkages from provincial datasets. Recruitment commenced in October 2013 and will continue for approximately three years. DISCUSSION: This trial will provide important information about the generalizability of Nurse-Family Partnership to the Canadian context. Findings will be published in peer-reviewed journals and shared with policymakers and practitioners through extensive public health collaborations already underway. TRIAL REGISTRATION: Registered July 18, 2013 with ClinicalTrials.gov Identifier: NCT01672060 .

British Columbia Healthy Connections Project process evaluation: a mixed methods protocol to describe the implementation and delivery of the Nurse-Family Partnership in Canada.

BACKGROUND: The Nurse-Family Partnership is a home visitation program for first-time, socially and economically disadvantaged mothers. The effectiveness of this public health intervention has been well established in the United States; however, whether the same beneficial outcomes will be obtained within the Canadian context is unknown. As part of the British Columbia Healthy Connections Project, which includes a trial comparing Nurse-Family Partnership's effectiveness with existing services in British Columbia, we are conducting a process evaluation to describe and explain how the intervention is implemented and delivered across five regional Health Authorities. METHODS: A convergent parallel mixed methods research design will be used to address the process evaluation objectives. The principles of interpretive description will guide all sampling, data collection and analytic decisions in the qualitative component of the study. The full population of public health nurses and supervisors (n = 71) will discuss their experiences of implementing and delivering the program in interviews (or focus groups). Managers (n = 5-15) responsible for this portfolio will also be interviewed annually. Fidelity reports with quantitative data on the reach and the dose of the intervention will be collected and analyzed. Summaries of team meetings and supervisory sessions will be analyzed. Data will be used to compare, corroborate and explain results and variances across the five regional Health Authorities. DISCUSSION: The process evaluation results will be of immediate instrumental use to the program implementers to inform intervention delivery. Findings will contribute to the emerging body of evidence surrounding: 1) professional nurse home visitation practice issues; 2) best practices for meeting the needs of families living in rural and remote communities; 3) a deeper understanding of how health and social issues such as mental health problems including substance misuse and exposure to intimate partner violence affect a young mother's capacity to parent; and 4) strategies to support professionals from the primary care, public health and child welfare sectors to work collaboratively to meet the needs of children and families who are at risk or experiencing maltreatment.

Mothers' experiences in the Nurse-Family Partnership program: a qualitative case study.

BACKGROUND: Few studies have explored the experiences of low income mothers participating in nurse home visiting programs. Our study explores and describes mothers' experiences participating in the Nurse-Family Partnership (NFP) Program, an intensive home visiting program with demonstrated effectiveness, from the time of program entry before 29 weeks gestation until their infant's first birthday. METHODS: A qualitative case study approach was implemented. A purposeful sample of 18 low income, young first time mothers participating in a pilot study of the NFP program in Hamilton, Ontario, Canada partook in one to two face to face in-depth interviews exploring their experiences in the program. All interviews were digitally recorded and transcribed verbatim. Conventional content analysis procedures were used to analyze all interviews. Data collection and initial analysis were implemented concurrently. RESULTS: The mothers participating in the NFP program were very positive about their experiences in the program. Three overarching themes emerged from the data: 1. Getting into the NFP program; 2. The NFP nurse is an expert, but also like a friend providing support; and 3. Participating in the NFP program is making me a better parent. CONCLUSIONS: Our findings provide vital information to home visiting nurses and to planners of home visiting programs about mothers' perspectives on what is important to them in their relationships with their nurses, how nurses and women are able to develop positive therapeutic relationships, and how nurses respond to mothers' unique life situations while home visiting within the NFP Program. In addition our findings offer insights into why and under what circumstances low income mothers will engage in nurse home visiting and how they expect to benefit from their participation.

The effect of delivery method on breastfeeding initiation from the The Ontario Mother and Infant Study (TOMIS) III.

OBJECTIVE: To report on the relationship between delivery method (cesarean vs. vaginal) and type (planned vs. unplanned) and breastfeeding initiation in hospital and continuation to 6 weeks postpartum as self-reported by study participants. DESIGN: Quantitative sequential mixed methods design. SETTING: Women were recruited from 11 hospital sites in Ontario, Canada. PARTICIPANTS: Participants included 2,560 women age 16 years or older who delivered live, full-term, singleton infants. METHODS: Data were collected from an in-hospital questionnaire, hospital records, and a 6-week postpartum interview. RESULTS: Ninety-two percent of women reported initiating breastfeeding, and 74% continued to 6 weeks. The method of delivery, when defined as cesarean versus vaginal, was not a determining factor in breastfeeding initiation in hospital or in the early postdischarge period. An unexpected delivery method (i.e., unplanned cesarean or instrument-assisted vaginal deliveries) was associated, at a statistically significant level, with an increased likelihood of initiating breastfeeding and continuation to 6 weeks postdischarge. CONCLUSION: Breastfeeding can be considered a coping strategy that serves to normalize an abnormal experience and allows the individual to once again assume control. These unexpected results warrant further investigation to understand why women make the decision to initiate breastfeeding, why they choose to continue breastfeeding, and how they can be supported to achieve exclusive breastfeeding as recommended for infants in the first 6 months.

Adaptation and implementation of the nurse-family partnership in Canada.

OBJECTIVES: International agencies are required to adapt, pilot and then evaluate the effectiveness of the Nurse-Family Partnership (NFP) prior to broad implementation of this public health intervention. The objectives of this qualitative case study were to: 1) determine whether the NFP can be implemented in Canada with fidelity to the US model, and 2) identify the adaptations required to increase the acceptability of the intervention for service providers and families. PARTICIPANTS: 108 low-income, first-time mothers in Hamilton, Ontario, received the NFP intervention. In-depth interviews were conducted with NFP clients (n=38), family members (n=14) and community professionals (n=24). SETTING: Hamilton, Ontario.INTERVENTION AND DATA COLLECTION: An intensive nurse home visitation program delivered to women starting early in pregnancy and continuing until the child was two years old. Processes to adapt and implement the NFP were explored across seven focus groups with public health nurses and managers. Eighty documents were reviewed to identify implementation challenges. Data were analyzed using directed content analysis. OUTCOMES: The NFP model elements are acceptable to Canadian health care providers, public health nurses and families receiving the intervention. The primary adaptation required was to reduce nurse caseloads from 25 to 20 active clients. Recommendations for adapting and implementing all model elements are described. CONCLUSION: The NFP model requires minor adaptations to increase the acceptability of the intervention to Canadian stakeholders. A consistent approach to adapting the NFP program in Canada is necessary as provincial jurisdictions commit themselves to supporting an experimental evaluation of the effectiveness of the NFP.

Where do young children in specialty care come from?: a preliminary investigation of the role of primary care physicians.

INTRODUCTION: Young children with mental health and developmental problems may not receive appropriate or timely interventions. Primary care physicians are well positioned to play an important role in the early identification and referral of such children. The objective of this pilot study was to explore the role primary care physicians played for a group of such children. METHODS: A single mailing of 1196 self-report questionnaires were sent to parents/caregivers of children under six years of age at four specialty centers in Ontario and Alberta. Key items on the survey included the role of primary care physicians (family physicians and community paediatricians). RESULTS: Twenty percent of parents/caregivers returned questionnaires. All children saw either a family physician or a community paediatrician, while 65% saw both. Families were more likely to have come to the specialty centre via a referral from a community paediatrician than a family physician. Ten percent reportedly received no referrals from a primary care physician, while 21% did not receive a referral to a specialty centre from these providers. CONCLUSIONS: The majority of children received at least one referral from a primary care physician. Further inquiry is required to determine the timeliness and appropriateness of these referrals.

Brief report: pilot investigation of service receipt by young children with autistic spectrum disorders.

Whether children with autistic spectrum disorders (ASD) and their families are receiving recommended assessments and services is poorly known. This pilot study examined service receipt as reported by parents of young children with ASD (n = 64) from four specialty centers in Canada. While almost all children had a speech and language assessment (94%), less than half had psychological (42%), or genetic (31%) testing. Speech and language (88%) and occupational (78%) therapies were the most frequently received treatments. Overall, certain findings did not correspond to recent recommended practice guidelines. Future studies should obtain more detailed information on assessments and treatments received from larger and more representative samples to better determine the quality of care received by families with children with ASD.

The impact of a new universal postpartum program on breastfeeding outcomes.

The Ontario Mother and Infant Study II examined changes in postpartum health outcomes, including breastfeeding initiation and discontinuation, for mothers and their infants and compared these results to data collected prior to the initiation of the Universal Hospital Stay and Postpartum Home Visiting Program policy change in 1998. Data were collected using cross-sectional surveys before discharge and at 4 weeks postdischarge. Ninety percent of the women surveyed at 4 weeks postpartum initiated breastfeeding. Of these, 84% were still breastfeeding at 4 weeks postpartum. None of the 3 major program components-extended length of stay, a postpartum phone call from a public health worker, or a postpartum in-home visit-were associated with breastfeeding continuation to 4 weeks. Discontinuation before 4 weeks postdischarge was associated with maternal attitudes toward breastfeeding, formula feeding or supplementation in hospital, infant readmission, and use of walk-in clinics for infant care.

A cross-sectional study of early identification of postpartum depression: implications for primary care providers from The Ontario Mother & Infant Survey.

BACKGROUND: This survey's objective was to provide planning information by examining utilization patterns, health outcomes and costs associated with existing practices in the management of postpartum women and their infants. In particular, this paper looks at a subgroup of women who score >or= 12 on the Edinburgh Postnatal Depression Survey (EPDS). METHODS: The design is cross-sectional with follow-up at four weeks after postpartum hospital discharge. Five Ontario hospitals, chosen for their varied size, practice characteristics, and geographic location, provided the setting for the study. The subjects were 875 women who had uncomplicated vaginal deliveries of live singleton infants. The main outcome measures were the EPDS, the Duke UNC Functional Social Support Questionnaire and the Health and Social Services Utilization Questionnaire. RESULTS: EPDS scores of >or= 12 were found in 4.3 to 15.2% of otherwise healthy women. None of these women were being treated for postpartum depression. Best predictors of an EPDS score of >or= 12 were lack: of confident support, lack of affective support, household income of <20,000 dollars, wanting to stay in hospital longer, identification of learning needs while in hospital, self-identified care needs for an emotional/mental health problem that have not been met and mother's rating of own and baby's health as fair or poor. CONCLUSIONS: Primary care physicians, midwives, and public health nurses need to screen for depression at every opportunity early in the postpartum period. A mother's expression of undue concern about her own or her baby's health may be predictive of postpartum depression. Flexible, mother-focused support from community providers may decrease the prevalence of postpartum depression.