Right from the start: protocol for a pilot study for a randomised trial of the New Baby Programme for improving outcomes for children born to socially vulnerable mothers.

作者信息

Macdonald Geraldine, Alderdice Fiona, Clarke Mike, Perra Oliver, Lynn Fiona, McShane Theresa, Millen Sharon

机构信息

1School for Policy Studies, University of Bristol, 8 Priory Road, Bristol, BS8 4BQ UK.

2National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Oxford, OX3 7LF UK.

出版信息

Pilot Feasibility Stud. 2018 Feb 2;4:44. doi: 10.1186/s40814-018-0235-2. eCollection 2018.

DOI:10.1186/s40814-018-0235-2

PMID:29435357

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5797371/

Abstract

BACKGROUND

Children born to mothers who experience social complexity (e.g. substance misuse, intimate partner violence, mental ill health, a history of maltreatment) are at increased risk for a range of adverse outcomes at birth and during development. Home visiting programmes have been advocated as a strategy for improving outcomes for disadvantaged mothers and children, such as the Nurse-Family Partnership for young, socially disadvantaged first-time mothers. However, no evidence-based programme is available for multiparous women or older first-time mothers. The New Baby Programme was developed in Northern Ireland. It augments the universal health visiting service available in the UK with a content designed to promote maternal health and well-being in pregnancy, maximise secure attachments of children and parents and enhance sensitive parenting and infant cognitive development.

METHODS/DESIGN: This pilot study is designed to investigate whether it is possible to recruit and retain socially vulnerable mothers in a randomised trial that compares the effects of the New Baby Programme with standard antenatal and postnatal care. Feasibility issues include the referral/recruitment pathway (including inclusion and exclusion criteria), the consent and randomisation, the ability to maintain researcher blinding, the acceptability of the intervention to participants, and the feasibility and acceptability of the outcome measures. The results of the study will inform a definitive phase-3 RCT.

DISCUSSION

Trials of complex social interventions often encounter challenges that lead to the trial being abandoned (e.g. because of problems in recruitment) or present considerable analytic challenges relating to dropout, attrition and bias. This pilot study aims to maximise the chances of successful implementation.