Ginsberg Kristin H, Alsweiler Jane, Rogers Jen, Cavadino Alana, Douglas Meihana, Serlachius Anna
Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
Department of Paediatrics: Child and Youth Health, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.
Contemp Clin Trials. 2024 May;140:107519. doi: 10.1016/j.cct.2024.107519. Epub 2024 Mar 27.
Parents with babies in the neonatal intensive care unit (NICU) experience high levels of stress, anxiety, and depression. The NICU experience may also lead to impaired parenting and early childhood socio-emotional problems. Psychosocial interventions can reduce NICU parent distress. Yet many are time-intensive and costly to deliver. Acceptance and Commitment Therapy (ACT), an evidence-based psychological therapy, may address these needs. ACT has been shown to be effective in reducing distress of parents of children with chronic illnesses, particularly when combined with parent education. Therefore, the primary aim of this study is to determine if a digital intervention that uses a brief form of ACT plus parent education will reduce the stress of primary caregivers with preterm babies in the NICU more than a digital education-only intervention or standard care control group.
In a randomised controlled cluster trial design, participants will be randomly assigned to one of three groups: ACT plus education; education-only; or standard care control. The primary outcome will be parental/caregiver stress levels, measured on the Parental Stress Scale: Neonatal Intensive Care Unit. Secondary outcomes include overall stress, anxiety, and depression. Outcome measures will be evaluated at baseline, two weeks after enrolment, discharge to home, and 3-months post-discharge.
This study will explore the efficacy of a digital ACT plus education intervention on parental stress levels. While position papers have advocated for the use of ACT with NICU parents, this study will be the first to test ACT as a stand-alone intervention with this population.
This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry on 14 June 2023 (ACTRN12623000641695p).
新生儿重症监护病房（NICU）中患儿的父母承受着高度的压力、焦虑和抑郁。NICU的经历还可能导致育儿能力受损以及儿童早期社会情感问题。心理社会干预可以减轻NICU患儿父母的痛苦。然而，许多干预措施实施起来耗时且成本高昂。接纳与承诺疗法（ACT）是一种循证心理疗法，可能满足这些需求。ACT已被证明能有效减轻患有慢性病儿童的父母的痛苦，特别是与家长教育相结合时。因此，本研究的主要目的是确定一种采用简短形式的ACT加家长教育的数字干预措施，是否比仅进行数字教育的干预措施或标准护理对照组更能减轻NICU中早产儿主要照料者的压力。
在一项随机对照整群试验设计中，参与者将被随机分配到三组中的一组：ACT加教育组；仅教育组；或标准护理对照组。主要结局将是父母/照料者的压力水平，采用《父母压力量表：新生儿重症监护病房版》进行测量。次要结局包括总体压力、焦虑和抑郁。结局指标将在基线、入组两周后、出院回家时以及出院后3个月进行评估。
本研究将探讨数字ACT加教育干预对父母压力水平的疗效。虽然立场文件主张对NICU患儿父母使用ACT，但本研究将是首次对这一人群单独测试ACT干预措施。
本试验于2023年6月14日在澳大利亚新西兰临床试验注册中心进行了前瞻性注册（ACTRN12623000641695p）。
