Wittkowski Anja, Cartwright Kim, Emsley Richard, Bee Penny, Calam Rachel, Cross Catherine, Abel Kathryn M, Reid Holly
Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Zochonis Building, Brunswick Street, Manchester, M13 9PL, UK.
Department of Clinical Psychology, Greater Manchester Mental Health NHS Foundation Trust, Laureate House, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LK, UK.
Trials. 2018 Sep 10;19(1):479. doi: 10.1186/s13063-018-2869-z.
There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, evidence-based parenting interventions as a matter of routine. This paper describes a study to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to evaluate a parenting and psychological intervention targeting the mother's and infant's wellbeing for mothers admitted to a MBU.
METHODS/DESIGN: This study is a multisite, single-blind feasibility trial with half the participants randomised to the Baby Triple P Positive Parenting Programme plus treatment as usual (TAU) and the other half randomised to TAU alone. Self-report and observer-rated assessments are collected at baseline, 10 weeks post-baseline and 6 months post-baseline. Participants are mothers admitted to a MBU in the Northwest of England or the Midlands. Participants are included if they are fluent in English to provide informed, written consent. Our objective is to determine whether we can recruit 66 women, randomise 60, and retain them in the intervention and study, and whether the intervention and study procedures are acceptable. As part of a nested process evaluation, qualitative interview data from trial participants and MBU staff will inform feasibility and acceptability. The feasibility of collecting data required to conduct an economic evaluation of the intervention will also be explored.
Although research has been conducted in relation to mothers with severe mental illness and MBUs, to our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake and retention alongside the potential efficacy of a parenting intervention for this population. This study is essential to examine the contextual challenges involved in this setting with this population and to identify any refinements required.
ISRCTN12765736 . Date of first registration: 2 February 2017.
对于没有严重精神疾病（SMI）的父母而言，育儿干预措施的益处有着强有力的证据基础。由于母亲患严重精神疾病会对儿童发育产生重大影响，母亲们需要获得支持，以便为自己和孩子实现最佳结果。一些患有严重精神疾病的母亲需要与婴儿一起入住母婴病房（MBU），即精神科住院病房，进行评估和治疗。然而，母婴病房目前尚未常规提供经过正式评估且基于证据的育儿干预措施。本文描述了一项研究，旨在调查开展一项随机对照试验（RCT）的可行性和可接受性，该试验旨在评估针对入住母婴病房的母亲及其婴儿福祉的育儿和心理干预措施。
方法/设计：本研究是一项多中心、单盲可行性试验，一半参与者被随机分配到“积极育儿三重P项目”（Baby Triple P Positive Parenting Programme）加常规治疗（TAU）组，另一半被随机分配到仅接受常规治疗组。在基线、基线后10周和基线后6个月收集自我报告和观察者评分评估。参与者为入住英格兰西北部或中部地区母婴病房的母亲。如果她们能流利使用英语以提供知情的书面同意书，则被纳入研究。我们的目标是确定我们是否能够招募66名女性、随机分配60名，并使她们参与干预和研究，以及干预和研究程序是否可接受。作为嵌套过程评估的一部分，来自试验参与者和母婴病房工作人员的定性访谈数据将为可行性和可接受性提供信息。还将探讨收集干预措施经济评估所需数据的可行性。
尽管已经针对患有严重精神疾病的母亲和母婴病房开展了研究，但据我们所知，这是第一项测试育儿干预措施对该人群的可行性、可接受性、参与率和保留率以及潜在疗效的对照试验。本研究对于检查该环境中涉及该人群的背景挑战以及确定所需的任何改进措施至关重要。
ISRCTN12765736。首次注册日期：2017年2月2日。
