Building Blocks II – Evaluating the long-term effectiveness, and the cost and consequences of the Family Nurse Partnership parenting support programme in reducing maltreatment in young children


Lead investigator
Mike Robling
Background

Co-contributors: K Hood, A Kemp, C Butler, J Sanders, S Holland, J Segrott

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.
Aims & objectives
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.
Study design
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.

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.

Start date
July 2016
End date
December 2018
Funders

Scottish Government

Amount
£183,137