Title: Evaluating the long-term effectiveness, and the cost and consequences of the Family Nurse Partnership parenting support programme in reducing maltreatment in young children
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background: In the first of 3 US trials of NFP (US name for FNP), by age 2 there was verified abuse / neglect in 19% of control children compared to 4% in NFP group and 56% relative reduction in emergency department encounters for injuries and ingestions during the second year of life. By age 4, amongst maltreated children, NFP group of children exhibited fewer risks for harm than control group (e.g. fewer attendances with injuries / ingestions, safer home environment). In the 15 years after birth, mothers as perpetrators of abuse were less common in NFP vs control arm (0.29 vs 0.54; p<0.001), an effect even greater for the most vulnerable sub-group (low SES, unmarried; 0.11). Whilst the beneficial impact upon risk of state-verified first-time reports of maltreatment was experienced after age 5, this difference was earlier (age 3) for the most vulnerable sub-group of poor unmarried mothers. Design: Participants will enter this study upon exit from the Building Blocks trial (age 2 of their first born child) and followed until that child is aged 6. Half of the proposed study participants will have been offered FNP at randomisation, the other half would have continued to receive usual health and social care services locally available. Follow-up will be by data abstraction from health and social care records. Baseline and follow-up data from the Building Blocks trial will be incorporated in the proposed follow-up study analysis. Research aims & objectives: We will examine the longer-term impact of the FNP intervention upon child maltreatment (child in need status, referral to Children’s Social Care(CSC)) and associated outcomes of maltreatment (e.g. injuries and ingestions). The impact of theoretical moderators of programme effect and fidelity to programme will be assessed and will use data already collected (e.g. presence of domestic violence, baseline socio-demographics) and data collected prospectively in this study. Conceptual intermediate outcomes of programme effect will be assessed (i.e. subsequent pregnancies). Longer-term cost and consequences of the intervention (health resource usage) will be assessed. Setting & recruitment: Potential participants are currently enrolled in the Building Blocks trial. Sites encompass a mix of deprived urban and rural settings across England. Target population: Women who were aged under 20 when conceiving their first child, who planned to reside within the study area delivering FNP until their child was 2 years old, who had the capacity to consent to trial participation (including conversational English, as FNP remains to be validated for delivery via interpreters). Study sites were those identified as having the organisational capacity to support intervention delivery and a clear social and clinical need (i.e. high levels of health inequality). Intervention: FNP is an intensive parenting support programme delivered by specially trained nurses from the point at which pregnancy is confirmed until the newly born child is 2. A prescribed schedule of up to 30 visits addresses key content areas to promote improved pregnancy outcomes, child health and development and maternal economic self-sufficiency. Skilful programme delivery is facilitated by practitioner training in Motivational Interviewing, local supervision for nurses and centralised support by a Department of Health policy team. Measurement of outcome: Primary outcome: rates of children classified as a child in need. Secondary outcomes: other objective measures of maltreatment (e.g. referral to CSC), associated measures of maltreatment (including accidents and injuries), possible moderators of abuse and programme effect (e.g. domestic violence). Data will be abstracted from medical and social care records. The former will include health visitor, HES and data from the Department of Health. Services will be approached and paid to provide data. Sample size: 1645 women were recruited to the original trial. Following mandatory withdrawals, 1570 remain eligible for follow-up through records. A 10% loss to follow-up would result in 1413 participants. Assuming an underlying rate of 8%, to detect a difference of 4% in Child in Need status would require 1204 children in total (80% power; two-sided 5% alpha). Planned analyses: Analyses will be by intention to treat, comparing the two groups using multilevel modelling to allow for clustering of effect. Modelling the impact of key subgroups and different intervention elements (e.g. dosage) on outcome will be undertaken by extending the primary models and testing for interaction effects. Group differences in profile of maltreatment will be assessed (e.g. timing, category, referral source, perpetrator). Economic evaluation will consider costs and consequences of the FNP over the full time period of trial follow-up. Project timetable: Approval will be requested for data abstraction via the Confidentiality Advisory Group (section 251 approval) in 2014. Data will be abstracted at two timepoints from health and social care records. Results will be available early 2019. Stakeholder involvement: We will extend an existing model of stakeholder involvement to advise the research team which will encompass graduates of the FNP programme in England, as well as other local stakeholders.

Lay abstract: A programme of home visiting by specially trained nurses (called the Family Nurse Partnership or FNP) aims to support teenagers expecting their first child. The programme is currently being compared to usual health and social care in a study involving 18 English centres which follows children until they are two years old. This proposed study will follow up the same women (a total of 1570 remain eligible) and their children for a further four years until their child is 6. The FNP programme has been shown to reduce maltreatment of children in US studies, but has not yet been assessed for effectiveness in England where care usually provided to such families is likely to be quite different. In this proposed study we will measure whether the FNP programme reduces maltreatment by accessing medical and social care records of participating women and their children. The study will examine what aspect of programme delivery or of the participants themselves may affect outcomes. Approval will be sought to collect information from the health / social care records of existing trial participants. All information collected will be entered onto secured computer databases for analysis. The applicants include the team conducting the current effectiveness study of FNP in England which has successfully recruited the largest number of trial participants for this intervention to date in the world (n=1645). This application therefore proposes to monitor programme effectiveness over the next developmental stage in an existing group of women and children, reducing the costs over a new trial of a similar intervention.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: GENERIC HEALTH RELEVANCE