从一开始：一项针对“新婴儿计划”随机试验的试点研究方案，该计划旨在改善社会弱势母亲所生孩子的结局。

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.

TRIAL REGISTRATION

ISRCTN35456296 retrospectively registered.

摘要

背景

母亲经历社会复杂性（如药物滥用、亲密伴侣暴力、心理健康问题、虐待史）的儿童在出生时及发育过程中出现一系列不良后果的风险会增加。家庭访视计划已被倡导为改善弱势母亲和儿童结局的一种策略，例如针对年轻、社会处境不利的初产妇的护士-家庭伙伴关系计划。然而，目前尚无基于证据的计划可供经产妇或年龄较大的初产妇使用。“新宝宝计划”是在北爱尔兰制定的。它在英国现有的全民健康访视服务基础上进行扩充，其内容旨在促进孕期母亲的健康和幸福，最大化儿童与父母之间的安全依恋关系，并加强敏感性养育和婴儿认知发展。

方法/设计：这项试点研究旨在调查是否有可能在一项随机试验中招募并留住社会弱势母亲，该试验将比较“新宝宝计划”与标准产前和产后护理的效果。可行性问题包括转诊/招募途径（包括纳入和排除标准）、同意和随机分组、保持研究人员盲法的能力、干预措施对参与者的可接受性，以及结局指标的可行性和可接受性。该研究结果将为确定性的3期随机对照试验提供信息。