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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Neonatal Unit, Homerton University Hospital
RECRUITING
London
Neonatal Unit, Whipps Cross University Hospital
RECRUITING
London
Contact Information
Primary
Rupa Rubinstein, MRCPCH
rupa.rubinstein@nhs.net
02085105555
Backup
Narendra Aladangady, PhD
n.aladangady@nhs.net
02085105555
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 40
Related Therapeutic Areas
Sponsors
Leads: Homerton University Hospital NHS Foundation Trust

This content was sourced from clinicaltrials.gov