Infant Parent Support (IPS): a multidisciplinary intervention to improve the mental health of children with a social worker - a study protocol for a feasibility randomised controlled trial with embedded process evaluation.

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Jaycee Pownall, Karen Crawford, Lindsay Dalgarno, Judith Fisher, Sharon Graham, Fiona Turner, Helen Minnis, Kathleen Boyd, Abril Seyahian, Alex McConnachie, Nicola Cosgrave, Matt Forde, Carol Atkinson, Janet McCullough, Kapil Sayal, Dennis Ougrin
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引用次数: 0

Abstract

Background: In many families where children have a social worker, parents have experienced challenges in their own childhoods or have neurodevelopmental conditions. These families often endure significant stress, which is frequently worsened by financial or housing challenges. This added pressure can strain relationships and increase the risk of child maltreatment, as well as contribute to mental health issues in children. Relationship-focused interventions show promise in preventing child maltreatment, although there are currently no interventions that simultaneously address neurodevelopmental conditions and the impact of poverty. We have co-produced, alongside parent experts-by-experience, local stakeholders, and infant mental health practitioners, a new service called Infant Parent Support (IPS). IPS will i) adopt a relationship-focused approach to comprehensive understanding of family functioning, ii) incorporate child and parent mental health and neurodevelopmental awareness, and iii) ensure a poverty aware approach throughout. The aim of this phase is to investigate the feasibility of a definitive Randomised Controlled Trial (RCT) of IPS compared with services-as-usual (SAU).

Methods: The study settings are social care services in two local authorities: Glasgow City Council (Scotland) and the London Borough of Bromley (England). Our target population is children on a 'child in need' plan (or the Scottish equivalent) and eligible participants are families where i) the infant(s) are aged 0-5 years and ii) the family has an allocated social worker plus a multi-agency support plan. Thirty participants will be identified by social workers and randomised to receive either IPS or SAU. Families randomised to IPS will receive an intensive multidisciplinary attachment-focused assessment that provides a foundation for relationship-focused interventions. IPS will incorporate child and parent mental health and neurodevelopmental awareness and ensure a poverty aware approach throughout. Families randomised to SAU will receive the assessment and support that social care services normally implement. We will utilise a pre-post and 3/6-month follow-up design with embedded mixed-method process evaluation and exploratory economic analysis. The primary objective is to assess if enough families can be recruited, randomised, and retained in the trial such that a full-scale RCT is likely to be feasible. The secondary objectives are to assess the acceptability and feasibility of the planned outcome measures and the IPS intervention to families and professionals.

Conclusions: A service like IPS, that uses a relationship-focused approach to child and parent mental health, neurodevelopmental and money/housing problems, has never previously been tested. Therefore, there are several areas of uncertainty that need to be addressed before moving onto a definitive RCT. TRIAL REGISTRATION {2A AND 2B}: Registered in ClinicalTrials.gov Identifier: NCT06003582. Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children with a Social Worker. Registered 22/08/2023. https://classic.

Clinicaltrials: gov/ct2/show/NCT06003582 .

婴儿父母支持(IPS):与社会工作者一起改善儿童心理健康的多学科干预——一项具有嵌入过程评估的可行性随机对照试验的研究方案。
背景:在许多孩子有社工的家庭中,父母在自己的童年经历过挑战或有神经发育问题。这些家庭往往承受着巨大的压力,而经济或住房方面的挑战往往会使这种压力进一步恶化。这种增加的压力会使关系紧张,增加儿童遭受虐待的风险,并导致儿童出现心理健康问题。虽然目前还没有能够同时解决神经发育问题和贫困影响的干预措施,但以关系为重点的干预措施在防止儿童虐待方面显示出希望。我们与经验丰富的父母专家、当地利益相关者和婴儿心理健康从业人员共同推出了一项名为“婴儿父母支持”(IPS)的新服务。IPS将i)采取以关系为重点的方法,全面了解家庭功能;ii)纳入儿童和父母的心理健康和神经发育意识;iii)确保始终采取认识贫穷的方法。本阶段的目的是研究IPS与常规服务(SAU)的确定性随机对照试验(RCT)的可行性。方法:研究设置为两个地方当局的社会护理服务:格拉斯哥市议会(苏格兰)和伦敦布罗姆利自治市镇(英格兰)。我们的目标人群是“有需要的儿童”计划(或苏格兰同等计划)中的儿童,符合条件的参与者是以下家庭:1)婴儿年龄在0-5岁之间;2)家庭有分配的社会工作者和多机构支持计划。社会工作者将确定30名参与者,并随机分配接受IPS或SAU。随机分配到IPS的家庭将接受以依恋为重点的密集多学科评估,为以关系为重点的干预提供基础。IPS将把儿童和父母的心理健康和神经发育意识纳入其中,并确保在整个过程中采取意识到贫困的办法。被随机分配到特殊护理单位的家庭将接受社会护理服务通常实施的评估和支持。我们将采用前后和3/6个月的随访设计,其中包括嵌入式混合方法流程评估和探索性经济分析。主要目的是评估是否有足够的家庭可以被招募,随机化,并保留在试验中,这样一个全面的随机对照试验可能是可行的。第二个目标是评估计划的结果措施和IPS干预对家庭和专业人员的可接受性和可行性。结论:像IPS这样的服务,使用以关系为中心的方法来解决儿童和父母的心理健康、神经发育和金钱/住房问题,以前从未被测试过。因此,在进行最终的随机对照试验之前,有几个不确定的领域需要解决。试验注册{2A和2B}:在ClinicalTrials.gov注册,编号:NCT06003582。社工干预改善儿童心理健康的合作制作及可行性RCT。22/08/2023注册。https://classic.Clinicaltrials: gov/ct2/show/NCT06003582。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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