title: First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse.
abstract: BACKGROUND
  Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness.
  
  
  METHODS
  The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged < 20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. 'Low educational qualifications' is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment.The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services.
  
  
  CONCLUSIONS
  This is the first study of the effectiveness of gFNP in the UK. Results should inform decision-making about its delivery alongside universal services, potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting.
  
  
  BACKGROUND
  ISRCTN78814904.
authors.affiliation: Birkbeck, University of London, London, UK. jacqueline.barnes@bbk.ac.uk.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Barnes
authors.forename: Dipti
authors.initials: D
authors.lastname: Aistrop
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Allen
authors.forename: Jane
authors.initials: J
authors.lastname: Barlow
authors.forename: Diana
authors.initials: D
authors.lastname: Elbourne
authors.forename: Geraldine
authors.initials: G
authors.lastname: Macdonald
authors.forename: Edward
authors.initials: E
authors.lastname: Melhuish
authors.forename: Stavros
authors.initials: S
authors.lastname: Petrou
authors.forename: Joshua
authors.initials: J
authors.lastname: Pink
authors.forename: Claire
authors.initials: C
authors.lastname: Snowdon
authors.forename: Helen
authors.initials: H
authors.lastname: Spiby
authors.forename: Jane
authors.initials: J
authors.lastname: Stuart
authors.forename: Joanna
authors.initials: J
authors.lastname: Sturgess
mesh_terms: D000223:Adaptation, Psychological; D002649:Child Abuse / Q000517:prevention & control* / Q000523:psychology; D002985:Clinical Protocols; D004522:Educational Status; D004739:England; D022143:Family Nursing; D005260:Female; D006126:Group Processes; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008423:Maternal Age; D008425:Maternal Behavior; D009034:Mother-Child Relations; D009035:Mothers / Q000523:psychology*; D016487:Parenting; D010342:Patient Acceptance of Health Care; D011247:Pregnancy; D011314:Preventive Health Services / Q000379:methods*; D015397:Program Evaluation; D011788:Quality of Life; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012944:Social Support; D013315:Stress, Psychological / Q000175:diagnosis / Q000523:psychology; D013997:Time Factors; D016896:Treatment Outcome; D014741:Video Recording; D055815:Young Adult