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Fathers and Partners in Family Integrated Care Study

NCT06022991 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

  • Mental Health Wellness 1
  • Premature Birth

Sponsors & Collaborators

  • Homerton University Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Narendra Aladangady, PhD · Homerton Healthcare NHS Foundation Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022991 on ClinicalTrials.gov