Rubinstein Rupa, Gallagher Katie, Ho John, Bose Julian, Khashu Minesh, Aladangady Narendra
Neonatal Unit, Homerton Healthcare NHS Foundation Trust, London, United Kingdom.
Blizard Institute, Queen Mary University London, London, United Kingdom.
JMIR Res Protoc. 2024 Mar 25;13:e53160. doi: 10.2196/53160.
Neonatal unit (NU) admissions for premature babies can last for months, which can significantly impact parental mental health (MH) with symptoms of depression, stress, and anxiety. Literature suggests fathers experience comparable MH symptoms to mothers. Family integrated care (FICare) is a culture where parents are collaborators and partners in caring for their hospitalized newborns. FICare improves infant outcomes and maternal MH. Similar reports on fathers are limited.
The primary aim of this study is to investigate the impact of supporting father or partner engagement in FICare of preterm infants on their MH up to 6 weeks postdischarge. The secondary aim is to investigate the impact on maternal MH.
This is a 2-phase study: phase 1 to gather baseline information and phase 2 to assess the impact of enhanced father or partner engagement in FICare on their MH, involving 2 NUs (tertiary and level 2). Enhanced FICare will be developed and introduced (eg, information booklet, workbook, classes, and a father peer-support group) alongside standard FICare practices. Father or partner MH will be assessed with semistructured qualitative interviews and validated questionnaires: Generalized Anxiety Disorder Assessment, Patient Health Questionnaire, and Parental Stressor Scale: Neonatal Intensive Care Unit from NU admission to 6 weeks postdischarge. Mothers will be assessed by focus groups and the same questionnaires. Descriptive statistics and appropriate comparative tests, such as the 2-tailed t test, will be used to analyze and compare phase 1 and 2 data. Qualitative data will be coded line by line with the use of NVivo (Lumivero) and thematically analyzed. Simultaneously, systematic reviews (SRs) of fathers' experiences of FICare and their MH outcomes will be conducted. The study was approved by the National Research Ethics Committee (22/EM/0140) in August 2022. A parent advisory group was formed to advise on the study methodology, materials, involvement of participant parents, and dissemination of study findings.
A recent SR demonstrated that data saturation is likely to be achieved by interviewing 9 to 17 participants. We will study a maximum of 20 parents of infants born at less than 33 weeks' gestation in each phase. As of October 2023, the study was ongoing. The SR studies are registered with the PROSPERO database (324275 and 306760). The projected end date for data collection is July 2024; data analysis will be conducted in November 2024 and publication will occur in 2025.
The study aims to demonstrate the feasibility of using a father or partner-sensitive FICare model for parents of premature babies with a positive impact on their MH. It will demonstrate the feasibility of providing FICare to extremely premature babies receiving intensive care. This study may support the development of inclusive FICare guidelines for nonbirthing parents and their extremely premature infants.
ClinicalTrials.gov: NCT06022991; https://classic.clinicaltrials.gov/ct2/show/NCT06022991.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53160.
早产儿入住新生儿病房（NU）的时间可能长达数月，这会对父母的心理健康（MH）产生重大影响，出现抑郁、压力和焦虑症状。文献表明，父亲经历的心理健康症状与母亲相当。家庭综合护理（FICare）是一种父母作为照顾住院新生儿的合作者和伙伴的文化。FICare可改善婴儿结局和母亲的心理健康。关于父亲的类似报告有限。
本研究的主要目的是调查支持父亲或伴侣参与早产儿FICare对其出院后6周内心理健康的影响。次要目的是调查对母亲心理健康的影响。
这是一项分两阶段的研究：第一阶段收集基线信息，第二阶段评估加强父亲或伴侣参与FICare对其心理健康的影响，涉及2个新生儿病房（三级和二级）。将在标准FICare实践的基础上制定并引入强化FICare（如信息手册、工作手册、课程和父亲同伴支持小组）。将通过半结构化定性访谈和经过验证的问卷对父亲或伴侣的心理健康进行评估：广泛性焦虑症评估、患者健康问卷和父母压力源量表：新生儿重症监护病房，从入住新生儿病房到出院后6周。将通过焦点小组和相同问卷对母亲进行评估。将使用描述性统计和适当的比较测试，如双尾t检验，来分析和比较第一阶段和第二阶段的数据。定性数据将使用NVivo（Lumivero）逐行编码并进行主题分析。同时，将对父亲参与FICare的经历及其心理健康结果进行系统评价（SRs）。该研究于2022年8月获得国家研究伦理委员会批准（22/EM/0140）。成立了一个家长咨询小组，就研究方法、材料、参与研究的家长以及研究结果的传播提供建议。
最近的一项系统评价表明，通过采访9至17名参与者可能实现数据饱和。我们将在每个阶段最多研究20名孕周小于33周的婴儿的父母。截至2023年10月，该研究正在进行中。系统评价研究已在PROSPERO数据库注册（324275和306760）。预计数据收集的结束日期为2024年7月；数据分析将于2024年11月进行，结果将于2025年发表。
该研究旨在证明对早产儿父母使用对父亲或伴侣敏感的FICare模型对其心理健康产生积极影响的可行性。它将证明为接受重症监护的极早产儿提供FICare的可行性。本研究可能支持制定针对非生育父母及其极早产儿的包容性FICare指南。
ClinicalTrials.gov：NCT06022991；https://classic.clinicaltrials.gov/ct2/show/NCT06022991。
国际注册报告标识符（IRRID）：DERR1-10.2196/53160。
