Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research

The consequences of preterm birth extend beyond the clinical conditions of the newborn, profoundly impacting the functioning and well-being of families. Although various research examines changes in parents' well-being and perception of self-efficacy during the stay in NICU, there is a lack of research analyzing what happens in the delicate transition phase at home after the baby's discharge. Recently, scholars have advocated for the use of web-based and app-based support programs both to monitor and prevent preterm family maladjustment and to assist parents struggling with the transition home. The main aim of this interdisciplinary research project is to develop a socio-psychological model focused on assessing the well-being of parents of premature infants during and after their stay in a NICU. Specifically, the study aims to (1) monitor the mental health of parents of premature infants, both at the time of the child's discharge from the NICU and in the first six months after discharge to prevent family maladjustment, (2) deepen our understanding of the role of digital tools in monitoring and supporting the well-being of parents of premature infants, and (3) study the potential impact of the relationship with healthcare professionals on the overall well-being of parents. The project combines mixed methods of social research and psychological support with an e-health approach. The well-being of parents of premature infants will be assessed using validated scales administered through a questionnaire to parents of preterm infants within six NICUs at the time of the child's discharge. Subsequently, a follow-up assessment of parental well-being will be implemented through the administration of the validated scales in a web app. Additionally, an ethnographic phase will be conducted in the NICUs, involving observation of the interaction between healthcare professionals and parents, as well as narrative interviews with healthcare staff. It is expected to shed light on the determinants of well-being among parents of premature infants, in relation to varying levels of prematurity severity, socio-demographic characteristics such as gender, age, and socioeconomic status, and parental involvement in NICU care practices. With the follow-up phase via web app, the project also aims to prevent family maladjustment by providing psychological support and utilizing an e-health tool.

NCT Number	NCT06495762
Lead Sponsor	University of Milano Bicocca Collaborators: Catholic University of the Sacred Heart, Treviso Regional Hospital, Ospedale San Bortolo di Vicenza, Azienda Ospedaliero Universitaria di Cagliari, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Ospedale San Raffaele, Azienda Ospedaliera San Gerardo di Monza
Conditions	Psychological Distress
Enrollment	350 participants
Start Date	2024-09-02
Primary Completion	2025-08-31 (estimated)
Study Completion	2025-10-01 (estimated)
Updated on ClinicalTrials.gov	2024-07-11