Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 10, 2023
Date Accepted: Jan 11, 2024
CLINICAL RESEARCH STUDY PROTOCOL 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
ABSTRACT
Background:
Neonatal unit (NU) admissions for premature babies can last for many months and this can significantly impact parental mental health (MH) with symptoms of depression, stress and anxiety. Family Integrated Care (FICare) is a culture in the NU whereby parents are collaborators and partners in the care of their hospitalised newborn. FICare has been shown to improve infant outcomes and improve maternal MH and similar reports on fathers are limited.
Objective:
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. The secondary aim is to investigate the impact on maternal MH.
Methods:
This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of enhanced father/partner engagement in FICare on their MH involving two NUs (a tertiary and level 2). Enhanced FICare will be developed and introduced (e.g., information booklet, workbook, bitesize classes and a father peer support group) alongside standard FICare practices. Father/partner MH will be assessed by semi-structured qualitative interviews and using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU) from the first week of infant's admission to six weeks post-discharge. Similarly, mothers will be assessed by the same questionnaires and focus groups. Descriptive statistics and appropriate comparative tests such as the T-test or Mann-Whitney test, will be used to analyse the questionnaire results and to compare results between phases 1 and 2. Qualitative data will be coded line by line with the use of NVivo software and thematically analysed. Simultaneously, a systematic review of fathers’ involvement in FICare and their MH outcomes will be conducted. The study was approved by the National Research Ethics Committee (22/EM/0140). A Parent Advisory Group was formed to review/advice on the study methodology, materials, actual involvement of parents in the study and dissemination of the study findings.
Results:
A recent systematic review of qualitative study demonstrated that data saturation is achieved by interviewing 9 to 17 participants and we will study maximum of 20 parents of infants born at 22 to <33 weeks in each phase. As of October 2023, the study is ongoing. The systematic review studies have been registered with the PROSPERO database (Reference: 324275 and 306760). The projected end date for data collection is around July 2024, data analysis is November 2024 and publication in early 2025.
Conclusions:
The study hopes to demonstrate the feasibility of employing a father/partner-sensitive FICare model for fathers of premature babies with a positive impact on paternal and maternal MH. The study will demonstrate the feasibility of providing FICare to extremely premature babies while receiving intensive care. Clinical Trial: clinicaltrials.gov: NCT06022991
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