Actively Recruiting
Fathers and Partners in Family Integrated Care Study
Led by Homerton University Hospital NHS Foundation Trust · Updated on 2023-09-05
40
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fathers and Partners in Family Integrated Care Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents of infants born between 22+0 and 32+6 weeks gestation
- Infant age from day one to 7 days old
- Infant has two primary caregivers; father's or partner's participation is required, and ideally both parents participate
- Parents must be able to speak conversational English
You will not qualify if you...
- Infant has a life-limiting condition or no realistic chance of survival
- Infant likely to be transferred to a non-participating center within 4 weeks of age
- Parents are under 16 years old
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Neonatal Unit, Whipps Cross University Hospital
London, United Kingdom, E11 1NR
Actively Recruiting
2
Neonatal Unit, Homerton University Hospital
London, United Kingdom, E9 6SR
Actively Recruiting
Research Team
R
Rupa Rubinstein, MRCPCH
CONTACT
N
Narendra Aladangady, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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