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.

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.

Afternoon cortisol provides a link between self-regulated anger and peer-reported aggression in typically developing children in the school context.

Aggression jeopardizes positive development in children and predicts social and academic maladjustment in school. The present study determined the relationships among anger dysregulation (a marker of emotion regulation), cortisol activity (a biomarker of stress), and peer-nominated aggression in typically developing children in their everyday classroom setting (N = 151, Mean age = 10.86, SD =.74). Salivary cortisol was collected at 09:15, 11:45, and 14:45 hr across 4 consecutive days. Children provided self-reports of anger regulation; peers reported proactive and reactive aggressive behaviors. Hierarchical linear regression analyses, followed by a bootstrapping analysis identified basal afternoon cortisol as a significant mediator between anger regulation and peer-reported aggression. More dysregulated anger significantly predicted lower afternoon cortisol, which in turn predicted increased peer-reported aggression. These results align with previous research on links among hypocortisolism, emotional regulation, and behavior, and suggest a possible meditational pathway between emotion and behavior regulation via decreased afternoon cortisol levels.

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 .

Children's perceptions and comforting strategies to infant crying: relations to age, sex, and empathy-related responding.

This study aimed to examine child characteristics associated with the understanding of and responses to infant crying. Seven hundred and twenty-four 1st to 7th grade children (383 boys, 341 girls) were shown a picture depicting a crying infant, whereupon they were asked to generate the potential causes for infant crying along with the action responses that they might utilize to assist a crying baby. Self-reports of children's empathy-related responding were also obtained. As hypothesized, an age-related increase in the number, variety, and quality for causes for infant crying and strategies to help a crying infant were observed. Girls generated a higher mean number and variety of causes compared to boys. For older children (grades 4-7), dimensions of empathy-related responding, namely sympathy and perspective taking, were significantly associated with the number and variety of causes for infant crying and caregiving strategies. The findings support the conclusion for a developmental progression of understanding of facial expressions of infant crying across middle childhood.

Getting the word out: advice on crying and colic in popular parenting magazines.

The objective of this study is to determine whether advice in parenting magazines reflects current evidence-based understanding of early infant crying and colic, where (1) "colic" is the upper end of a spectrum of crying behavior reflective of normal infant development, and (2) physical abuse--in particular, shaken baby syndrome (SBS)--is a serious medical consequence of early crying. All available issues of 11 popular Canadian parenting magazines published between January 2000 and December 2004 were hand-searched and systematically reviewed. Fifty-one articles were found with information on: (1) causes of, (2) responses to, and/or (3) mention of SBS or abuse as a consequence of crying and/or colic. There were 105 specific causes suggested, but almost no agreement concerning the causes of crying and colic. Similarly, there were 231 specific responses to crying and colic mentioned, but little agreement among the suggested responses. For both crying and colic together, the consequence of abuse was mentioned only 7 times, and SBS only twice. Making the advice literature a truly helpful vehicle for parents concerning normal behavioral development and its consequences for their new infant seems to be a significant challenge. Arguably, this is an important shared responsibility of physicians, researchers, and journalists.

Inverse association between the effect of carbohydrates on blood glucose and subsequent short-term food intake in young men.

BACKGROUND: A primary mechanism by which carbohydrates are thought to regulate satiety and food intake is through their effect on blood glucose. OBJECTIVES: The objectives were to describe the effect of defined carbohydrate preloads on food intake and blood glucose and to determine the association between food intake and blood glucose. DESIGN: Three experiments were conducted in which selected carbohydrates as 1255-kJ isovolumetric beverages were administered to young men after an overnight fast. Measurements of blood glucose and appetite were made at specified times during the next 60 min. Food intake was measured at 60 min. RESULTS: Glucose resulted in the highest glycemic response, which was followed, in order, by the responses to polycose, sucrose, amylopectin, a fructose-glucose mixture, and amylose. The high-glycemic-index preloads (glucose, polycose, and sucrose) resulted in lower mealtime energy intake during a test meal at 1 h, but the low-glycemic-index preloads (amylose, amylopectin, and a fructose-glucose mixture) did not. An inverse relation was observed between the blood glucose concentrations in the area under the curve and the subjective appetite (r = -0.23, P < 0.05) and food intake at 60 min (r = -0.24, P < 0.05). CONCLUSIONS: Food intake and subjective appetite are inversely associated with blood glucose response in the 60 min after consumption of carbohydrates. Carbohydrates with a high glycemic index (glucose, polycose, and sucrose) suppress subjective appetite and food intake in the short term, but those with a low glycemic index (amylose and amylopectin) do not.