Woman-Mother-Child, Clinic of Neonatology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Child and Adolescent Psychiatry, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
BMJ Open. 2019 Mar 30;9(3):e026484. doi: 10.1136/bmjopen-2018-026484.
Preterm birth may generate significant distress among the parents, who often present with difficulties in appropriating their parental role. Parental stress and low perceived parental self-efficacy may interfere with the infant's socioemotional and cognitive development, particularly through disrupted parent-infant interactions. Perceived parental self-efficacy represents the belief of efficacy in caring for one's own infant and successful incarnation of the parental role, as well as the perception of one's own abilities to complete a specified task. Interventions to support parental role, as well as infant development, are needed, and parental self-efficacy represents a useful indicator to measure the effects of such early interventions.
This study protocol describes a randomised controlled trial that will test an early intervention in the neonatal intensive care unit (NICU) (JOIN: Joint Observation In Neonatology) carried out by an interdisciplinary staff team. Mothers of preterm neonates born between 28 and 32 6/7 weeks of gestational age are eligible for the study. The intervention consists of a videotaped observation by a clinical child psychologist or child psychiatrist and a study nurse of a period of care delivered to the neonate by the mother and a NICU nurse. The care procedure is followed by an interactive video guidance intended to demonstrate the neonate's abilities and resources to his parents. The primary outcome will be the difference in the perceived maternal self-efficacy between the intervention and control groups assessed by self-report questionnaires. Secondary outcomes will be maternal mental health, the perception of the parent- infant relationship, maternal responsiveness and the neurodevelopment of the infant at 6 months corrected age.
Ethical approval was granted by the Human Research Ethics Committee of the Canton de Vaud (study number 496/12). Results from this study will be disseminated at national and international conferences, and in peer-reviewed journals.
NCT02736136, Pre-results.
早产儿出生可能会给父母带来巨大的痛苦，他们常常难以适应父母的角色。父母的压力和低自我效能感可能会干扰婴儿的社会情感和认知发展，特别是通过破坏亲子互动。自我效能感是指对照顾自己孩子的效能感，成功地体现了父母的角色，以及对自己完成特定任务的能力的感知。需要干预措施来支持父母的角色和婴儿的发展，而自我效能感是衡量早期干预效果的有用指标。
本研究方案描述了一项随机对照试验，该试验将在新生儿重症监护病房（NICU）中进行一项早期干预（JOIN：联合观察新生儿学），由一个跨学科的工作人员团队实施。28 至 32 6/7 孕周出生的早产儿的母亲有资格参加这项研究。干预措施包括由临床儿童心理学家或儿童精神科医生和一名研究护士对母亲和 NICU 护士为新生儿提供的护理期进行录像观察，然后由一名研究护士对录像进行录像观察。随后是一个互动视频指导，旨在向父母展示新生儿的能力和资源。主要结果将是通过自我报告问卷评估干预组和对照组之间母亲自我效能感的差异。次要结果将是母亲的心理健康、父母-婴儿关系的感知、母亲的反应能力和婴儿在 6 个月校正年龄时的神经发育。
人类研究伦理委员会（沃州研究编号 496/12）已批准这项研究。这项研究的结果将在国家和国际会议上以及同行评议的期刊上发表。
NCT02736136，预结果。
