title: Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Department of Health Policy Research Programme.
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK. Electronic address: roblingmr@cardiff.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Robling
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Marie-Jet
authors.initials: MJ
authors.lastname: Bekkers
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: Kerry
authors.initials: K
authors.lastname: Bell
authors.affiliation: Nuffield Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Butler
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Cannings-John
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Channon
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: Belen Corbacho
authors.initials: BC
authors.lastname: Martin
authors.affiliation: School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: John W
authors.initials: JW
authors.lastname: Gregory
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Kerry
authors.initials: K
authors.lastname: Hood
authors.affiliation: School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Kemp
authors.affiliation: Faculty of Life Sciences and Education, University of South Wales, Pontypridd, UK.
authors.forename: Joyce
authors.initials: J
authors.lastname: Kenkre
authors.affiliation: Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK; Bristol Randomised Trials Collaboration, University of Bristol, Bristol, UK.
authors.forename: Alan A
authors.initials: AA
authors.lastname: Montgomery
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Gwenllian
authors.initials: G
authors.lastname: Moody
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK.
authors.forename: Eleri
authors.initials: E
authors.lastname: Owen-Jones
authors.affiliation: Department of Health Sciences, University of York, York, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Pickett
authors.affiliation: Centre for Health Economics, University of York, York, UK.
authors.forename: Gerry
authors.initials: G
authors.lastname: Richardson
authors.affiliation: School of Medicine, Cardiff University, Cardiff, UK.
authors.forename: Zoë E S
authors.initials: ZE
authors.lastname: Roberts
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ronaldson
authors.affiliation: School of Healthcare Sciences, Cardiff University, Cardiff, UK.
authors.forename: Julia
authors.initials: J
authors.lastname: Sanders
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: Eugena
authors.initials: E
authors.lastname: Stamuli
authors.affiliation: York Trials Unit, University of York, York, UK.
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
mesh_terms: D000293:Adolescent; D001724:Birth Weight; D001942:Breast Feeding; D002657:Child Development; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D004739:England / Q000453:epidemiology; D022143:Family Nursing; D005260:Female; D006699:Home Care Services; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007229:Infant Welfare; D007231:Infant, Newborn; D016389:Maternal-Child Nursing; D011247:Pregnancy; D020377:Self Efficacy; D012907:Smoking / Q000453:epidemiology; D012944:Social Support; D055815:Young Adult