Clinical trial NCT06495762: Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research
Official title: Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Psychological Distress
Keywords: Preterm birth
Parental well-being
Sociology of Health
Digital-Based Monitoring
Mixed-method Research
e-Health
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: Treviso Regional Hospital
name: Ospedale San Bortolo di Vicenza
name: Azienda Ospedaliero Universitaria di Cagliari
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: IRCCS Ospedale San Raffaele
name: Azienda Ospedaliera San Gerardo di Monza
First posted: 2024-07-11
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of preterm child who were born in one of the partner NICU during the monitoring phase of the project.

Brief summary: 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.

Detailed description: Brief statement of primary study objectives and the main secondary study objectives.

The e-ParWelB project is an interdisciplinary study which, starting from the premises of the ParWelB project, aims to evaluate the well-being of preterm parents during and after hospitalization in the Neonatal Intensive Care Unit NICU using research strategies such as standardized questionnaires with internationally validated scales and psychological support with an innovative and technology-driven approach. Recently scholars have supported the use of Web-App-based support programs to monitor and prevent maladjustment of preterm families and assist parents who have difficulty transitioning from the NICU to home (Sawyer et al., 2019; Greene et al., 2020). Furthermore, the work of Garfield et al. (2016) with very low birth weight infants demonstrated that parents who received an app-based support program improved self-efficacy and their perception of preparedness for discharge.

Starting from these premises, the main objectives of our research can be summarised as follows: (1) monitor the mental health of parents of children born prematurely, with a six-month follow-up to prevent family maladjustment ; (2) deepen knowledge on the role of digital tools in monitoring and supporting the mental health of parents whose infants have been admitted to neonatal intensive care for critical health situations such as prematurity.

Brief statement of primary study outcome and primary estimand/estimator. Then describe the main secondary study outcome measures.

Considering the time and economic resources available, we estimate to intercept the families of approximately 175 children born preterm, thus roughly a sample of 350 participants.

The validated scales employed will be used to create statistical indices measuring concepts such as levels of stress, depression, parental self-efficacy and perception of social support received from parents. These variables will be correlated through statistical processing and modelling with independent socio-demographic variables (gender, age, nationality, ...), and indicators of economic, social and cultural capital.

The research assumes to find statistically significant differences in the levels of stress, anxiety and self-efficacy with respect to sample segmentations related to gender, educational background and migration variables.

Eligibility criteria: Inclusion Criteria:

* Parents of children born before 36+6 of gestational age (GA).
* The parents must be at least 18 years old
* Children must have been hospitalized in intensive or sub-intensive care for at least ten days.
* Parents must be able to speak fluent Italian or English.

Exclusion Criteria:

- Children must not have other genetic pathologies or other pathologies not linked to the preterm birth.

Primary outcomes:
measure: Postpartum Anxiety
timeFrame: The scale is administered 3 times: the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025), 30 days after child's discharge (from 01/10/2024 to 28/03/2025) and 180 days after child's discharge (from 01/03/2024 to 28/09/2025).
measure: Post-partum PTSD
timeFrame: The scale is administered 2 times: the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025) and 90 days after child's discharge (from 01/12/2024 to 28/05/2025).
measure: Post-partum depression
timeFrame: The scale is administered 2 times: the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025) and 90 days after child's discharge (from 01/12/2024 to 28/05/2025).
measure: Post-partum parent-child bonding
timeFrame: The scale is administered once, the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025).
measure: Parenting-related stress
timeFrame: The scale is administered 3 times: 30 days after child's discharge from NICU (from 01/10/2024 to 28/03/2025), 60 days after child's discharge from NICU (from 01/11/2024 to 28/04/2025) and 180 days after child's discharge (from 01/03/2024 to 28/09/2025).
Secondary outcomes:
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Dipartimento Materno infantile, Terapia Intensiva Neonatale, Azienda Ospedaliero-Universitaria di Cagliari
state: CA
city: Monza
country: Italy
facility: S.C. Neonatologia e Terapia Intensiva Neonatale, I.R.C.C.S. Ospedale San Gerardo Monza
state: MB
city: Milano
country: Italy
facility: U.O Neonatologia e Patologia Neonatale, I.R.C.C.S. Ospedale San Raffaele
state: MI
city: Pavia
country: Italy
facility: S.C. Neonatologia e Terapia Intensiva Neonatale, Fondazione IRCCS Policlinico San Matteo di Pavia.
state: PV
city: Treviso
country: Italy
facility: U.O.C. di Terapia Intensiva Neonatale, patologia neonatale ed assistenza al neonato sano presso il Presidio Ospedaliero di Treviso
state: TV
city: Vicenza
country: Italy
facility: UOSD di Terapia Intensiva e Patologia Neonatale presso l'ospedale di Vicenza (ULSS 8 Berica).
state: VI
Study officials:
affiliation: University of Milano Bicocca
name: Alessandra Decataldo, PhD
role: PRINCIPAL_INVESTIGATOR
References: