Division of Biostatistics and Study Methodology, Children's Research Institute, Children's National Health System, 111 Michigan Ave NW, Washington, DC 20010, USA.
Department of Neonatology, Children's National Health System, 111 Michigan Ave NW, Washington, DC 20010, USA; Center for Translational Science, Children's Research Institute, Children's National Health System, 111 Michigan Ave NW, Washington, DC 20010, USA.
Contemp Clin Trials. 2018 Jul;70:117-134. doi: 10.1016/j.cct.2018.05.004. Epub 2018 May 5.
Parents of infants hospitalized in a neonatal intensive care unit (NICU) experience increased anxiety and stress, which may persist after discharge. The rationale and design of a randomized clinical trial assessing the impact of a 1-year, post-discharge, peer support intervention (parent navigation) on parental mental health and infant health care utilization is described. Qualitative methods guided the adaptation of an existing parent support program to target emotional and resource-related needs of NICU families. Approximately 300 parent-infant dyads were enrolled at discharge and randomized to either receive a care notebook (control group) or a parent navigator and a care notebook (intervention group). We aim to determine if the parent navigator intervention: 1) increases self-efficacy and decreases stress in parents, 2) decreases overall levels of anxiety and depression in parents, 3) decreases infant hospitalizations and emergency department visits, and 4) increases adherence to infant vaccination recommendations during 1 year of follow-up. Standardized, self-reported psychological scales to assess parent depression, anxiety, self-efficacy and social support were administered at baseline (NICU discharge) and at 1-week, 1-, 3-, 6- and 12-month intervals. Infant immunization status and health care utilization during the study period were also assessed. This paper reviews challenges and successes during implementation. If this intervention improves outcomes, NICUs may choose to provide similar parent navigation services for infants and families transitioning from the NICU to home. This study was registered with ClinicalTrials.gov (NCT02643472) on December 31, 2015.
将婴儿住院于新生儿重症监护病房（NICU）的父母经历增加的焦虑和压力，这可能会持续到出院后。本文描述了一项随机临床试验的原理和设计，该试验评估了为期 1 年的出院后同伴支持干预（家长导航）对父母心理健康和婴儿保健利用的影响。定性方法指导了对现有家长支持计划的改编，以满足 NICU 家庭的情感和资源相关需求。大约 300 对母婴对在出院时入组并随机分为接受护理笔记本（对照组）或家长导航员和护理笔记本（干预组）。我们旨在确定家长导航员干预：1）是否增加父母的自我效能感并减轻其压力，2）是否降低父母的总体焦虑和抑郁水平，3）是否降低婴儿住院和急诊就诊次数，以及 4）在 1 年的随访期间是否增加婴儿疫苗接种建议的依从性。在基线（NICU 出院时）和 1 周、1、3、6 和 12 个月时，使用标准化的自我报告心理量表评估父母的抑郁、焦虑、自我效能感和社会支持。还评估了研究期间婴儿的免疫接种状况和医疗保健利用情况。本文回顾了实施过程中的挑战和成功。如果这种干预措施改善了结果，NICU 可能会选择为从 NICU 过渡到家庭的婴儿和家庭提供类似的家长导航服务。该研究于 2015 年 12 月 31 日在 ClinicalTrials.gov（NCT02643472）注册。
