跳至主要内容
临床试验/NCT06116747
NCT06116747Enrolling By Invitation不适用

Strengthening First-time Fathers' Engagement in Early Parenthood When Having a Preterm Infant - The SUPPORTED Study.

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 532 人开始时间: 2023年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
532
试验地点
2
主要终点
Paternal confidence: Karitane Parenting Confidence Scale (KPCS),

研究概览

简要总结

The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships. Improve paternal confidence by involving, knowledge sharing, and guiding them in their premature infants' emotional, nutritional, and developmental needs.

The study operates with two study populations: a) first-time fathers, their premature infants, and families, b) health care professionals working with new families in neonatal intensive care units and maternity units and the families' health visitors from the secondary health care sectors. Seven hospitals located in Denmark's five regions participates.

Four studies address the key questions for the father's involvement in supportive health care: 1) How do fathers experience their participation in father-groups in the NICU, 2) What are the first-time fathers' needs and preferences for supporting health care, 3) Development of an intervention based on the identified need to support the fathers in early parenting, 4) Study the process and effect of the intervention on paternal confidence and stress.

The first question is explored in a qualitative evaluation of an ongoing father-group intervention in a neonatal intensive care unit. The following three questions are studied through an action research approach, identifying first-time fathers' needs for support and the current practices among health professionals towards new first-time fathers of premature infants. Secondly, developing guiding principles for health care professionals to strengthen fathers' partnership in health care. Finally, conducting a quasi-experimental study to evaluate the process and effect of the proposed approaches. The study of this paternal supportive programme, involves perspectives that have not yet been studied in Denmark or internationally.

详细描述

Project description The overall aim of this research study is to identify, develop and evaluate whether supportive strategies for first-time fathers (FTF) of preterm infants will improve parental confidence, mood and anxiety as well as increasing paternal reflective function, and improve infants social-emotional competencies during admission in the Neonatal Intensive Care Unit (NICU), or Maternity Unit (MU) and follow up at home by health visitors in the municipalities in all five regions in Denmark. Thus, improve paternal confidence in the father role by involving, knowledge sharing, and guiding them in their infants' emotional, nutritional, and developmental needs.

Background Developing paternal confidence and engaging in the paternal role is pivotal to men's transition into fatherhood (1). The change in fatherhood culture from breadwinner to being involved in the care of the infant is challenging (2-4). Among first-time parents, fathers express more insecurity than mothers (5). Fathers of preterm infants experience even more insecurity as it is more difficult to read the infant's cues (6). Fathers have unique support needs that are frequently unmet (5,7), which may result in decreased mental health, father-infant interaction, and parenting confidence (7). In the health care system, they often feel like bystanders (4) even though they want a participating role to attach to the infant (8).

In Denmark, about 4.200 of 60.000 infants (7%) are born preterm (9). Preterm infants are admitted to the hospital for weeks or months due to immaturity of the organs. Information, emotional and practical support from healthcare professionals (HCP) are needed to enhance parents' experiences, well-being, caring, and confidence during admission and at home (10). Studies on fathers' involvement in early interventions of their preterm infant are limited (11). Generally, interventions that extend over a long period of time and include both primary and secondary sectors are the most effective (12). Studies have addressed parental relationships and insecurity and sought interventions to improve parents' opportunities to actively participate in care, showing positive effects, e.g., skin-to-skin helps fathers gain confidence in the paternal role (13). Across sections nurses, midwives, and health visitors provide early parenting support to all new families. There is a need to change the culture among HCP to increase the engagement of the father in a family-focused approach, and this requires the identification of changeable factors among HCPs in primary and secondary sectors like knowledge, attitudes, and behavior (14). Perceptions of fathers as important as the mother in early parenting are associated with favorable attitudes toward including them in family interventions; this association is mediated by the professionals' perception of their confidence (15).

Health- and socio-economic arguments exist for improving early paternal engagement, and fathers want to be engaged, attentive, and caring (16). Their involvement in fatherhood can benefit the health and well-being of both himself, the mother, and the infant (17). Fathers' engagement has been shown to improve social and relational functioning in childhood, decrease behavioral problems in adolescence, and increase educational outcomes (18,19).

Even though the Nordic countries have been at the forefront of involving fathers in pregnancy and delivery, evidence shows that fathers are still not included and approached by HCP equally to mothers. This project which works at and within all levels in the healthcare sector and across the country, has the potential to take the next step to a partnership with FTF of preterm infants by changing practice and culture to benefit the fathers, preterm infants, and families.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • First-time fathers of preterm infants
  • Co-habitating with the mother of the infant
  • Neonatal Admission for more than seven days
  • Danish language
  • Infants born before the 37 week of gestation

排除标准

  • Infant receiving palliative treatment and care
  • parents not discharged for home
  • parental mental illness

结局指标

主要结局

Paternal confidence: Karitane Parenting Confidence Scale (KPCS),

时间窗: 2 weeks, 4 month, 9 month corrected age

15 items, 0-1 year postpartum. (Črnčec et al., 2008, 2010).

次要结局

  • Infant social-emotional competence(4 month, 9 month corrected age)
  • Depression(2 weeks, 9 month corrected age)
  • Paternaty leave(4 month and 9 moths corrected age)
  • PSS: Parental Stress Scale(2 weeks, 4 month corrected age)
  • Paternal mentalizing competence: The Parental Reflective Functioning Questionnaire (PRFQ)(4 month corrected age)
  • Exclusive breastfeeding direct from the breast (2 items)(2 weeks, 4 month, 9 moths correced age)
  • FAD: Family Assessment Device(4 month corrected age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Brodsgaard

Professor

Hvidovre University Hospital

研究点 (2)

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