Fathers and Partners in Family Integrated Care Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHomerton University Hospital NHS Foundation Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Babies born between 22+0 and 32+6 weeks who have two main caregivers
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Paternal mental health
Fathers' mental stress is assessed by semi-structured interviews.
Time frame
From 1st week of baby's admission to discharge from the Neonatal Unit, up to 22 weeksSecondary outcomes
1
Fathers care giving ability
This will be assessed through semi-structured interview process.
Time frame
From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge2
Parental enagement
This will be assessed by telephone interview at 6 weeks after baby's discharge fromneonatal unit.
Time frame
6 weeks post baby discharge from Neonatal Unit3
Maternal mental health
Maternal stressor will be assessed by the PSS:NICU questionnaire
Time frame
From 1st week of baby's admission to Neonatal Unit up to 6 weeks post discharge4
Paternal mental health
Parental stressor will be assessed by the PSS:NICU questionnaire.
Time frame
From 1st week of baby's admission to Neonatal Unit up to 6 weeks post dischargeSponsors and contacts
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Source ClinicalTrials.gov