Fathers and Partners in Family Integrated Care Study

Recruiting now

Conditions studied: Mental Health Wellness 1, Premature Birth

In brief

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.

Key facts

Study ID

NCT06022991

Run by

Homerton University Hospital NHS Foundation Trust

People needed

40

Starts

2022-11-01

Expected to finish

2026-10-30

Last updated by the study team

2023-09-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parents of 22+0 to 32+6 weeks preterm infants.
• Infant from day one to 7 days of age.
• Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal.
• The parents should have conversational English.

You may not qualify if…

• Infant with life-limiting condition or no realistic chance of survival.
• Infant is likely to be transferred to non-participating centre within 4 weeks of age.
• Parents under the age of 16 years.

Where it is running

• Neonatal Unit, Whipps Cross University Hospital — London, United Kingdom (enrolling)
• Neonatal Unit, Homerton University Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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