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临床试验/NCT06022991
NCT06022991招募中不适用

TARGET Study: faThers And paRtners in Family inteGrated carE sTudy- A Prospective Multicentre Multiphase Study Investigating Father/Partner Involvement in Family Integrated Care in Neonatal Units

Homerton University Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Paternal mental health

研究概览

简要总结

AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary aims are to investigate the impact on maternal MH.

METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of improved father/partner engagement in FICare involving two NUs (a tertiary and level 2). 20 families of infants born at <33 weeks will be studied in each phase (40 fathers, 40 mothers, 40 babies).

Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be assessed by the same questionnaires and focus groups.

The Neonatal DadPad materials will be updated using information from phase 1 study, systematic review of Fathers experiences of FICare and advice from parent advisory group. Father's engagement in FICare will be enhanced using Neonatal DadPad information booklet and app, father-specific peer support and bitesize teaching on caring for NU babies (Phase 2).

Thematic analysis of the qualitative data will be performed. Phase 1 and Phase 2 study findings will be compared by performing appropriate statistical analysis.

详细描述

BACKGROUND: Family-integrated care (FIC) is a culture whereby parents are viewed as collaborators in their baby's care in neonatal units. This can be challenging for fathers/non-birthing partners as they face competing demands on their time to try and allow the mother to focus on her baby.

KEY AIMS AND OBJECTIVES:

Aims To undertake an in-depth longitudinal study of the engagement of fathers/partners in FiCare and their experience and mental health (MH) from neonatal unit admission to 6 weeks post discharge of their premature baby born at <33 weeks gestation.

Objectives:

  1. To assess baseline fathers' experiences in the NU, their involvement in FICare, and MH status during babies NU admission up to 6 weeks post-discharge
  2. To conduct systematic review (SR) of published articles on 'Fathers and FiCare in NU' and 'Fathers' MH in the NU'.
  3. To develop a programme to enhance involvement of fathers in FiCare.
  4. To introduce the programme developed to enhance fathers' involvement in FiCare and explore their experiences and effect on their MH.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Paternal mental health

时间窗: From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeks

Fathers' mental stress is assessed by semi-structured interviews.

次要结局

  • Fathers care giving ability(From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge)
  • Paternal mental health(From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge)
  • Parental enagement(6 weeks post baby discharge from Neonatal Unit)
  • Paternal depression(From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge)
  • Maternal mental health(From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge)
  • Paternal anxiety(From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge)

研究者

发起方
Homerton University Hospital NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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