Midgley Nick, Besser Sarah Jane, Dye Helen, Fearon Pasco, Gale Tim, Jefferies-Sewell Kiri, Irvine Karen, Robinson Joyce, Wyatt Solange, Wellsted David, Wood Sally
The Child Attachment and Psychological Therapies Research Unit (ChAPTRe), The Anna Freud National Centre for Children and Families, 12 Maresfield Gardens, London, NW3 5SU UK.
Research Department of Clinical, Educational and Health Psychology, University College London, Gower Street, London, WC1E 6BT UK.
Pilot Feasibility Stud. 2017 Feb 22;3:12. doi: 10.1186/s40814-017-0127-x. eCollection 2017.
A significant proportion of children in the social care system in England present with mental health problems, with the majority experiencing some form of emotional and behavioural difficulties. The most effective treatments for these children are currently unknown, partly due to a lack of robust, controlled studies. Researchers have identified a number of obstacles to conducting well-designed research with this population, making the need to test the feasibility of a randomised controlled trial especially important.
METHODS/DESIGN: This protocol outlines a two-arm, randomised control feasibility trial to explore the acceptability and credibility of mentalization-based treatment (MBT) as a treatment for reducing emotional and behavioural difficulties in looked after children and to test the possibility of addressing a number of methodological challenges to conducting high-quality research with this population. MBT is a relatively new intervention which, in the adaptation of the model tested here, includes many of the features of therapy identified in NICE guidelines as necessary to support children in care. The two arms are MBT and usual clinical care (UCC). The study will take place in Hertfordshire Partnership University NHS Foundation Trust with follow-up at 12 and 24 weeks.
This study will aim to ascertain whether it is worthwhile and feasible to progress to testing the intervention in a full-scale definitive randomised controlled trial (RCT). This study therefore has the potential to improve our understanding of the obstacles to conducting high-quality research with this very vulnerable population, and in the medium term, could help to improve the stability of foster placements and the emotional well-being of children in care.
ISRCTN90349442.
在英国社会照护系统中的相当一部分儿童存在心理健康问题,大多数儿童经历过某种形式的情绪和行为困难。目前尚不清楚针对这些儿童最有效的治疗方法,部分原因是缺乏有力的对照研究。研究人员已经确定了对这一人群进行精心设计研究的一些障碍,因此测试随机对照试验的可行性尤为重要。
方法/设计:本方案概述了一项双臂随机对照可行性试验,以探讨基于心理化的治疗(MBT)作为减少受照料儿童情绪和行为困难的治疗方法的可接受性和可信度,并测试应对针对该人群进行高质量研究的一些方法学挑战的可能性。MBT是一种相对较新的干预措施,在此处测试的模型改编中,包括了英国国家卫生与临床优化研究所(NICE)指南中确定的支持受照料儿童所需的许多治疗特征。两组分别为MBT和常规临床护理(UCC)。该研究将在赫特福德郡伙伴关系大学国民保健服务基金会信托基金进行,随访时间为12周和24周。
本研究旨在确定推进全面确定性随机对照试验(RCT)来测试该干预措施是否值得且可行。因此,本研究有可能增进我们对针对这一非常脆弱人群进行高质量研究的障碍的理解,从中期来看,有助于提高寄养安置的稳定性和受照料儿童的情绪健康。
ISRCTN90349442。