Evaluating the Family Nurse Partnership in England: a randomised controlled trial South East Wales Trials Unit, Cardiff University Dr Julia Sanders Consultant Midwife / Senior Project Manager

Family Nurse Partnership Programme

Who are Family Nurses? Registered Nurses or Midwives Health Visitors School Nurses Additional training programme Central team at Department of Health

Family Nurse Partnership Programme A structured, intensive home visiting programme delivered by Family Nurses to pregnant teenagers Programme runs through pregnancy and until babys second birthday. Licensed programme developed and tested in the USA with fidelity measures to ensure replication of original research

Visiting Schedule 1/week first month Every other week during pregnancy 1/week first 6 weeks after delivery Every other week until 21 months Once a month until age 2

Content of visits 6 domains Personal health – womens health practices and mental health Environmental health – adequacy of home and neighbourhood Life course development – womens future goals Maternal role – skills and knowledge to promote health and development of their child Family and friends – helping to deal with relationship issues and enhance social support Health and human services – linking to other services

7 FNP GOALS 1.Improve pregnancy outcomes 2.Improve child health and development and future school readiness and achievement 3.Improve parents economic self- sufficiency

8 FNP Structure 1.Small teams of Family Nurses (max 6) 2.A FNP supervisor to each team 3.Training and supervision provided directly by DoH

US trials of NFP N = 400 Low-income whites Semi-rural N = 1,138 Low-income blacks Urban Elmira, NY 1977 Memphis, TN 1987 Denver, CO 1994 N = 735 Large portion of Hispanics Nurse v para- professional visitors

Improvements in womens antenatal health Reductions in childrens injuries Fewer subsequent pregnancies Greater intervals between births Increases in fathers involvement Increases in employment Reductions in welfare and food stamps Improvements in school readiness Consistent positive effects across at least two trials

Sept 2006: Action Plan for Social Exclusion - proposal for 10 test sites of NFP £30M support allocated ( to ) Pilot running from March 2007 (10 sites): evaluation reported July 2008 US NFP adapted for English setting – Family Nurse Partnership 18 new sites invited to apply to be part of RCT – selected March 2008 Developing the Family Nurse Partnership In England

Family Nurse Partnership An introductory DVD

Overview of Trial Design

Overview of the Trial Design: Individually randomised controlled trial Participants: 2400 women aged 19 or under, recruited to RCT by 24 weeks and expecting first child Randomisation: Following baseline assessment by automated telephone allocation Stratification by site, gestation, smoking status and language of data collection

Trial Sites Barnsley Cornwall Coventry Cumbria Derby City Berkshire East Hull Lambeth Leeds Liverpool Manchester Northamptonshire South Birmingham Southwark Sunderland South East Essex Tower Hamlets Walsall

Eligibility Criteria Women will be included if they: Are aged 19 or under Live within the catchment area covered by the local FNP team Are expecting their first child (women whose previous pregnancy ended in miscarriage, stillbirth or termination are eligible for the trial) Can be recruited at no later than 24 weeks gestation Are Gillick competent to provide adequate informed consent to research participation (including competence in English at conversational level or higher). But excluded if they: Plan to have their child adopted Plan to leave the FNP area during the time of the trial either for 3+ months Women who would require an interpreter to receive the FNP programme

Outcome domain Changes in prenatal tobacco use (maternal measure) Birth weight (child measure) Pregnancy & birth Child health & development Maternal life course and economic self- sufficiency Emergency attendances / admissions within two years of birth Proportion of women with a second pregnancy within two years of first birth Intention to breastfeed Prenatal attachment Injuries & ingestions Breast feeding (initiation & duration) Language development Education Employment Health status Social support Paternal involvement PrimarySecondary Overview of the Trial Study Outcomes

Executive Management Group Lead applicant:Mike Robling Snr Project Mgr:Julia Sanders Co-applicants:Chris Butler Alison Kemp Joyce Kenkre Alan Montgomery Kate Pickett David Torgerson WP managers:Eleri Owen-Jones Ria Poole Economist (tbc) Dir, SEWTU:Kerry Hood

Progress Update Ethics MREC Approval granted Global Governance Checks completed Contracts R & D Required with 41 PCTs and NHS Trusts Eight variations have been required to cover different models of working Researchers Being employed by CLRNs, Trusts, PCTs, Joint Trusts Recruitment women recruited to date

Project Timetable Train local researchers (From May 2009) Recruit / randomise participants (June 2009 – Feb 2010) urine collection Consultation recordings (Jul 2009 – Jun 2012) Initial Service Mapping Interviews (Oct 2008 – Jun 2009) Focus groups (Feb 2010 – Aug 2010 / Dec 2011 – Jun 2012) 2 year FUP interview (Aug 2011 – Jun 2012) Reporting Jan 2013

Katy Addison, Study Administrator South East Wales Trials Unit, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS Dr Eleri Owen-Jones, Trial Manager Dr Julia Sanders, Midwife & Senior Project Manager Dr Mike Robling, Chief Investigator Research team details