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      Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial

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          Summary

          Background

          Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.

          Methods

          We did a pragmatic, non-blinded, randomised controlled, parallel-group trial in community midwifery settings at 18 partnerships between local authorities and primary and secondary care organisations in England. Eligible participants were nulliparous and aged 19 years or younger, and were recruited at less than 25 weeks' gestation. Field-based researchers randomly allocated mothers (1:1) via remote randomisation (telephone and web) to FNP plus usual care (publicly funded health and social care) or to usual care alone. Allocation was stratified by site and minimised by gestation (<16 weeks vs ≥16 weeks), smoking status (yes vs no), and preferred language of data collection (English vs non-English). Mothers and assessors (local researchers at baseline and 24 months' follow-up) were not masked to group allocation, but telephone interviewers were blinded. Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy, birthweight of the baby, the proportion of women with a second pregnancy within 24 months post-partum, and emergency attendances and hospital admissions for the child within 24 months post-partum. Analyses were by intention to treat. This trial is registered with ISRCTN, number ISRCTN23019866.

          Findings

          Between June 16, 2009, and July 28, 2010, we screened 3251 women. After enrolment, 823 women were randomly assigned to receive FNP and 822 to usual care. All follow-up data were retrieved by April 25, 2014. 304 (56%) of 547 women assigned to FNP and 306 (56%) of 545 assigned to usual care smoked at late pregnancy (adjusted odds ratio [AOR] 0·90, 97·5% CI 0·64–1·28). Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g (SD 618·0), whereas birthweight of 768 babies assigned to usual care was 3197·5 g (SD 581·5; adjusted mean difference 20·75 g, 97·5% CI −47·73 to 89·23. 587 (81%) of 725 assessed children with mothers assigned to FNP and 577 (77%) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday (AOR 1·32, 97·5% CI 0·99–1·76). 426 (66%) of 643 assessed women assigned to FNP and 427 (66%) 646 assigned to usual care had a second pregnancy within 2 years (AOR 1·01, 0·77–1·33). At least one serious adverse event (mainly clinical events associated with pregnancy and infancy period) was reported for 310 (38%) of 808 participants (mother–child) in the usual care group and 357 (44%) of 810 in the FNP group, none of which were considered related to the intervention.

          Interpretation

          Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes. Programme continuation is not justified on the basis of available evidence, but could be reconsidered should supportive longer-term evidence emerge.

          Funding

          Department of Health Policy Research Programme.

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          Most cited references25

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          The environment of poverty: multiple stressor exposure, psychophysiological stress, and socioemotional adjustment.

          The one in five children growing up in poverty in America have elevated risk for socioemotional difficulties. One contributing factor to their elevated risk may be exposure to multiple physical and psychosocial stressors. This study demonstrated that 8- to 10-year-old, low-income, rural children (N = 287) confront a wider array of multiple physical (substandard housing, noise, crowding) and psychosocial (family turmoil, early childhood separation, community violence) stressors than do their middle-income counterparts. Prior research on self-reported distress among inner-city minority children is replicated and extended among low-income, rural White children with evidence of higher levels of self- and parent-reported psychological distress, greater difficulties in self-regulatory behavior (delayed gratification), and elevated psychophysiological stress (resting blood pressure, overnight neuroendocrine hormones). Preliminary mediational analyses with cross-sectional data suggest that cumulative stressor exposure may partially account for the well-documented, elevated risk of socioemotional difficulties accompanying poverty.
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            Effectiveness of home visiting programs on child outcomes: a systematic review

            Background The effectiveness of paraprofessional home-visitations on improving the circumstances of disadvantaged families is unclear. The purpose of this paper is to systematically review the effectiveness of paraprofessional home-visiting programs on developmental and health outcomes of young children from disadvantaged families. Methods A comprehensive search of electronic databases (e.g., CINAHL PLUS, Cochrane, EMBASE, MEDLINE) from 1990 through May 2012 was supplemented by reference lists to search for relevant studies. Through the use of reliable tools, studies were assessed in duplicate. English language studies of paraprofessional home-visiting programs assessing specific outcomes for children (0-6 years) from disadvantaged families were eligible for inclusion in the review. Data extraction included the characteristics of the participants, intervention, outcomes and quality of the studies. Results Studies that scored 13 or greater out of a total of 15 on the validity tool (n = 21) are the focus of this review. All studies are randomized controlled trials and most were conducted in the United States. Significant improvements to the development and health of young children as a result of a home-visiting program are noted for particular groups. These include: (a) prevention of child abuse in some cases, particularly when the intervention is initiated prenatally; (b) developmental benefits in relation to cognition and problem behaviours, and less consistently with language skills; and (c) reduced incidence of low birth weights and health problems in older children, and increased incidence of appropriate weight gain in early childhood. However, overall home-visiting programs are limited in improving the lives of socially high-risk children who live in disadvantaged families. Conclusions Home visitation by paraprofessionals is an intervention that holds promise for socially high-risk families with young children. Initiating the intervention prenatally and increasing the number of visits improves development and health outcomes for particular groups of children. Future studies should consider what dose of the intervention is most beneficial and address retention issues.
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              Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial.

              Interest in home-visitation services as a way of improving maternal and child outcomes has grown out of the favorable results of a trial in semirural New York. The findings have not been replicated in other populations. To test the effect of prenatal and infancy home visits by nurses on pregnancy-induced hypertension, preterm delivery, and low birth weight; on children's injuries, immunizations, mental development, and behavioral problems; and on maternal life course. Randomized controlled trial. Public system of obstetric care in Memphis, Tenn. A total of 1139 primarily African-American women at less than 29 weeks' gestation, with no previous live births, and with at least 2 sociodemographic risk characteristics (unmarried, <12 years of education, unemployed). Nurses made an average of 7 (range, 0-18) home visits during pregnancy and 26 (range, 0-71) visits from birth to the children's second birthdays. Pregnancy-induced hypertension, preterm delivery, low birth weight, children's injuries, ingestions, and immunizations abstracted from medical records; mothers' reports of children's behavioral problems; tests of children's mental development; mothers' reports of subsequent pregnancy, educational achievement, and labor-force participation; and use of welfare derived from state records. In contrast to counterparts assigned to the comparison condition, fewer women visited by nurses during pregnancy had pregnancy-induced hypertension (13% vs 20%; P=.009). During the first 2 years after delivery, women visited by nurses during pregnancy and the first 2 years of the child's life had fewer health care encounters for children in which injuries or ingestions were detected (0.43 vs 0.55; P=.05); days that children were hospitalized with injuries or ingestions (0.03 vs 0.16; P<.001); and second pregnancies (36% vs 47%; P=.006). There were no program effects on preterm delivery or low birth weight; children's immunization rates, mental development, or behavioral problems; or mothers' education and employment. This program of home visitation by nurses can reduce pregnancy-induced hypertension, childhood injuries, and subsequent pregnancies among low-income women with no previous live births.
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                Author and article information

                Contributors
                Journal
                Lancet
                Lancet
                Lancet (London, England)
                Elsevier
                0140-6736
                1474-547X
                09 January 2016
                09 January 2016
                : 387
                : 10014
                : 146-155
                Affiliations
                [a ]South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK
                [b ]School of Medicine, Cardiff University, Cardiff, UK
                [c ]School of Healthcare Sciences, Cardiff University, Cardiff, UK
                [d ]York Trials Unit, University of York, York, UK
                [e ]Department of Health Sciences, University of York, York, UK
                [f ]Centre for Health Economics, University of York, York, UK
                [g ]Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK
                [h ]Faculty of Life Sciences and Education, University of South Wales, Pontypridd, UK
                [i ]Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
                [j ]Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK
                Author notes
                [* ]Correspondence to: Dr Michael Robling, South East Wales Trials Unit, Cardiff University, Cardiff CF14 4YS, UKCorrespondence to: Dr Michael RoblingSouth East Wales Trials UnitCardiff UniversityCardiffCF14 4YSUK roblingmr@ 123456cardiff.ac.uk
                Article
                S0140-6736(15)00392-X
                10.1016/S0140-6736(15)00392-X
                4707160
                26474809
                c4ed0d29-9c1c-4efa-be18-5a39f84fb96f
                © 2016 Robling et al. Open Access article distributed under the terms of CC BY-NC-ND

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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