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RECRUITING
NCT06022991

Fathers and Partners in Family Integrated Care Study

Sponsor: Homerton University Hospital NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2022-11-01

Completion Date

2026-10-30

Last Updated

2023-09-05

Healthy Volunteers

No

Locations (2)

Neonatal Unit, Whipps Cross University Hospital

London, United Kingdom

Neonatal Unit, Homerton University Hospital

London, United Kingdom