|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 general practice (via GPES once initiated). 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 National Information Governance Board (section 251 approval) in 2012. Data will be abstracted at two timepoints from health and social care records. 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.