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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 references 32

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          Home visiting by paraprofessionals and by nurses: a randomized, controlled trial.

          To examine the effectiveness of home visiting by paraprofessionals and by nurses as separate means of improving maternal and child health when both types of visitors are trained in a program model that has demonstrated effectiveness when delivered by nurses. A randomized, controlled trial was conducted in public- and private-care settings in Denver, Colorado. One thousand one hundred seventy-eight consecutive pregnant women with no previous live births who were eligible for Medicaid or who had no private health insurance were invited to participate. Seven hundred thirty-five women were randomized to control, paraprofessional, or nurse conditions. Nurses completed an average of 6.5 home visits during pregnancy and 21 visits from birth to the children's second birthdays. Paraprofessionals completed an average of 6.3 home visits during pregnancy and 16 visits from birth to the children's second birthdays. The main outcomes consisted of changes in women's urine cotinine over the course of pregnancy; women's use of ancillary services during pregnancy; subsequent pregnancies and births, educational achievement, workforce participation, and use of welfare; mother-infant responsive interaction; families' home environments; infants' emotional vulnerability in response to fear stimuli and low emotional vitality in response to joy and anger stimuli; and children's language and mental development, temperament, and behavioral problems. Paraprofessional-visited mother-child pairs in which the mother had low psychological resources interacted with one another more responsively than their control-group counterparts (99.45 vs 97.54 standard score points). There were no other statistically significant paraprofessional effects. In contrast to their control-group counterparts, nurse-visited smokers had greater reductions in cotinine levels from intake to the end of pregnancy (259.0 vs 12.32 ng/mL); by the study child's second birthday, women visited by nurses had fewer subsequent pregnancies (29% vs 41%) and births (12% vs 19%); they delayed subsequent pregnancies for longer intervals; and during the second year after the birth of their first child, they worked more than women in the control group (6.83 vs 5.65 months). Nurse-visited mother-child pairs interacted with one another more responsively than those in the control group (100.31 vs 98.99 standard score points). At 6 months of age, nurse-visited infants, in contrast to their control-group counterparts, were less likely to exhibit emotional vulnerability in response to fear stimuli (16% vs 25%) and nurse-visited infants born to women with low psychological resources were less likely to exhibit low emotional vitality in response to joy and anger stimuli (24% vs 40% and 13% vs 33%). At 21 months, nurse-visited children born to women with low psychological resources were less likely to exhibit language delays (7% vs 18%); and at 24 months, they exhibited superior mental development (90.18 vs 86.20 Mental Development Index scores) than their control-group counterparts. There were no statistically significant program effects for the nurses on women's use of ancillary prenatal services, educational achievement, use of welfare, or their children's temperament or behavior problems. For most outcomes on which either visitor produced significant effects, the paraprofessionals typically had effects that were about half the size of those produced by nurses. When trained in a model program of prenatal and infancy home visiting, paraprofessionals produced small effects that rarely achieved statistical or clinical significance; the absence of statistical significance for some outcomes is probably attributable to limited statistical power to detect small effects. Nurses produced significant effects on a wide range of maternal and child outcomes.
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            Is home visiting an effective strategy? A meta-analytic review of home visiting programs for families with young children.

            Home visiting programs for families with young children have been in effect for many years; however, this is the first comprehensive meta-analytic effort to quantify the usefulness of home visits as a strategy for helping families across a range of outcomes. Sixty home visiting programs contributed data to analysis within 5 child and 5 parent outcome groups. Standardized effect sizes were computed for each end-of-treatment outcome measure, for each treatment versus control contrast. Weighted mean standardized effect sizes ranged from -.043 to.318; 6 of the 10 significantly differed from 0. No one program characteristic consistently affected effect sizes across outcome groups. The extent to which these findings have practical use for the field is discussed.
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              The nurse–family partnership: An evidence-based preventive intervention

               David L Olds (2006)
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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
                © 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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