Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06022991 |
| Other study ID # |
152449 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2022 |
| Est. completion date |
October 30, 2026 |
Study information
| Verified date |
September 2023 |
| Source |
Homerton University Hospital NHS Foundation Trust |
| Contact |
Rupa Rubinstein, MRCPCH |
| Phone |
02085105555 |
| Email |
rupa.rubinstein[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
Methods
Study design:
This is a prospective multi-centre and multi-phase pilot study. Phase 1 will assess baseline
fathers' experiences in the NU, their involvement in FICare and MH status during babies' NU
admission up to 6 weeks post-discharge. Simultaneously, a systematic review of fathers'
involvement in FICare and their MH outcomes will be conducted. A programme to enhance the
involvement of fathers in FICare will be developed using information from phase-1 study,
systematic review, existing DadPad app and advice from parent advisory group (PAG). In
phase-2 study, enhanced father involvement programme in FICare will be implemented and
similar assessments as in phase-1 will be conducted (Figure 1). Regular debrief sessions, and
research updates/newsletters to keep staff engaged and supportive of the project will be
provided. This support will be continued throughout the study.
Study Centres: The study will be conducted at a tertiary neonatal unit (level 3) and a local
neonatal unit (level 2) as defined by the Department of Health, from East London, UK. The
Parent Advisory Group (PAG) will help to update the existing Neonatal DadPad app and booklet.
They will provide support in finalising topic guides for fathers' education classes for
phase-2 study. The PAG will also support in dissemination of the study findings to research
participants and the wider neonatal community.
Phase 1 study. Baseline Data Collection: 9 months
1. Prior to the introduction of the study to wider NU clinical staff members, staff
knowledge, experiences and opinions about the role of fathers and FICare will be
assessed by a questionnaire.
2. Once a parent is recruited, the Parental Stressor Scale: NICU (PSS:NICU)20, and MH
questionnaires (Generalised Anxiety Disorder Assessment (GAD-7)21 and, Patient Health
Questionnaire (PHQ-922)) will be given to complete within 7 days.
3. Fathers/partners will be invited to participate in 2 semi-structured interviews, within
2 weeks of recruitment and immediately prior to discharge. The interviews will explore
their MH, experiences of bonding with baby, understanding the neonatal environment, and
reflecting on their service expectations. Based on father's/partner's preference,
interviews will be undertaken either in a private room on the NU or virtually via MS
Teams at a mutually convenient time. Interviews will be digitally recorded and are
anticipated to last up to one hour. Data saturation is expected at around 12-15 fathers.
4. The parents will be asked to complete the PSS:NICU, GAD7 and PHQ9 questionnaires at 3
weekly intervals, finishing on the week of discharge, to monitor their MH through their
NU stay.
5. Up to 4 groups of 5 mothers will be invited to participate in a focus group to assess
their wellbeing, experience of the NU and their perspective on support for and from
their partners. This will occur in a room in the NU at a time convenient to the mothers.
Groups will be organised until data saturation is reached.
6. Telephone/online questionnaires will be completed by parents at 4-6 weeks post-discharge
to assess family confidence and bonding after NU discharge.
Washout, Phase 2 Preparation: 4 months
1. The existing Neonatal DadPad app/booklet (which is currently used in several NHS Trusts
to guide fathers through their NU journey) will be updated using phase-1 and systematic
review study findings with guidance from the PAG, and a programme to enhance father
participation within the FICare model will be developed.
2. Teaching sessions undertaken to educate and upskill all clinical NU staff on study aims,
recruitment, phase-1 study findings and upcoming phase-2 study, highlighting the
importance of fathers' role in the FICare (e.g., teaching parents how to safely give
nasogastric feeds, nappy changes in a ventilated baby).
Phase 2 study. Enhanced Father involvement in FICare: 9 months. Once a family is recruited,
the programme developed to enhance father involvement in FICare will be implemented to take
place at the parents' pace. The NU experience and MH status of both parents will be assessed
as in phase-1 study. At the end of phase-2 study, staff knowledge, experiences and opinions
about fathers and FICare will be re-assessed and compared to the start of the study.
