NCT06022991 Fathers and Partners in Family Integrated Care Study
| NCT ID | NCT06022991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Homerton University Hospital NHS Foundation Trust |
| Condition | Mental Health Wellness 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2022-11-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Parents of preterm infants will be recruited to the study. Inclusion criteria: 1. Parents of 22+0 to 32+6 weeks preterm infants. 2. Infant from day one to 7 days of age. 3. Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal. 4. The parents should have conversational English. Exclusion criteria: 1. Infant with life-limiting condition or no realistic chance of survival. 2. Infant is likely to be transferred to non-participating centre within 4 weeks of age. 3. Parents under the age of 16 years.
Contact & Investigator
Narendra Aladangady, PhD
STUDY DIRECTOR
Homerton Healthcare NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT06022991 clinical trial?
This trial is open to participants of all sexes, studying Mental Health Wellness 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06022991 currently recruiting?
Yes, NCT06022991 is actively recruiting participants. Contact the research team at rupa.rubinstein@nhs.net for enrollment information.
Where is the NCT06022991 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06022991 clinical trial?
NCT06022991 is sponsored by Homerton University Hospital NHS Foundation Trust. The principal investigator is Narendra Aladangady, PhD at Homerton Healthcare NHS Foundation Trust. The trial plans to enroll 40 participants.