Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research (e-ParWelB)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychological Distress
• Intervention / Treatment: Other: e-health assesment

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.

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Alessandra Decataldo, PhD; Phone Number: +39 0264487418; Email: alessandra.decataldo@unimib.it

Study Locations

• Italy
  • CA
    • Cagliari, CA, Italy, 09123
      • Dipartimento Materno infantile, Terapia Intensiva Neonatale, Azienda Ospedaliero-Universitaria di Cagliari
      • Contact: Vassilios Fanos; Phone Number: +39 07051093403; Email: vafanos@tiscali.it
  • MB
    • Monza, MB, Italy, 20900
      • S.C. Neonatologia e Terapia Intensiva Neonatale, I.R.C.C.S. Ospedale San Gerardo Monza
      • Contact: Maria Luisa Ventura; Phone Number: +39 030392331; Email: marialuisa.ventura@irccs-sangerardo.it
  • MI
    • Milano, MI, Italy, 20132
      • U.O Neonatologia e Patologia Neonatale, I.R.C.C.S. Ospedale San Raffaele
      • Contact: Antonella Poloniato; Phone Number: 02 26432623; Email: poloniato.antonella@hsr.it
  • PV
    • Pavia, PV, Italy, 27100
      • S.C. Neonatologia e Terapia Intensiva Neonatale, Fondazione IRCCS Policlinico San Matteo di Pavia.
      • Contact: Camilla Pisoni; Phone Number: +39 0382502518; Email: pisoni.camilla@gmail.com
  • TV
    • Treviso, TV, Italy, 31100
      • U.O.C. di Terapia Intensiva Neonatale, patologia neonatale ed assistenza al neonato sano presso il Presidio Ospedaliero di Treviso
      • Contact: Paola Lago; Phone Number: +39 0422322263; Email: paola.lago@aulss2.veneto.it
  • VI
    • Vicenza, VI, Italy, 36100
      • UOSD di Terapia Intensiva e Patologia Neonatale presso l'ospedale di Vicenza (ULSS 8 Berica).

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Anxiety	Measured through Postpartum Specific Anxiety Scale (PSAS). Most of the literature on postpartum anxiety (Glasheen, Richardson, & Fabio, 2010; Lostein, 2007; Meades & Ayers, 2011) refers to measures of generalised anxiety which can often prove problematic from a psychometric point of view. To date, the only questionnaire available that specifically measures postpartum anxiety is the Postpartum Specific Anxiety Scale (PSAS). The instrument also demonstrated excellent psychometric properties (ω between 0.72 and 0.90 in the four scales and λ4 between 0.71 and 0.92 in the four scales). For these reasons, the research team believed it was the most sensitive and suitable tool for capturing the construct under investigation in the target population (parents of children born preterm).	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).
Post-partum PTSD	Measured through City Birth Trauma Scale (City BiTS). The scale is an instrument specifically developed to measure birth-related post-traumatic stress disorder according to the recent DSM-5 criteria and is, to the authors' knowledge, the only instrument with this specificity. This instrument has previously demonstrated excellent reliability (Cronbach's a = 0.92). For these reasons, the research team believed it was the most sensitive and suitable tool for capturing the construct under investigation in the target population (parents of children born preterm).	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).
Post-partum depression	Measured through Edinbugh Postnatal Depression Scale (EPDS). Postnatal depression is the most widely measured disorder in the postpartum population which in Italy is mostly subject to routine checks. The Edinburgh Postnatal Depression Scale (EPDS) is the most widely used self-report questionnaire to measure postpartum depression given the simplicity of administration, ease of cultural adaptation and excellent psychometric properties demonstrated. The validated Italian version demonstrated good validity and reliability (Cronbach's α =0.7894), confirming the validity of the EPDS in identifying postnatal depression.	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).
Post-partum parent-child bonding	Measured through Postpartum Bonding Questionnaire (PBQ) (in T0). The scale aims to measure the quality of the bond between parents and children and identify if there are problems in the relationship. The Italian adaptation of the PBQ, edited by Rosario Montirosso, Claudia Fedeli, Livio Provenzi and Ian Brockington was developed using the back-translation procedure (Montirosso et al., 2009). Studies show that the Italian version of the PBQ has good psychometric properties and can be implemented in the Italian cultural context to assess early mother-child relational difficulties (Busonera et al., 2017).	The scale is administered once, the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025).
Parenting-related stress	Measured through Parenting Stress Index (PSI). The literature on existing research has highlighted the possibility of identifying stressful "child-parent" systems early in order to develop interventions aimed at reducing stress that can reduce the frequency and the intensity of emotional and behavioral disorders of children in our society (Cash et al., 2006; van Ijzendoorn et al., 2005). The Parenting Stress Index (PSI) was developed in response to the need for a measure to assess these characteristics.	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).

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: Catholic University of the Sacred Heart; Azienda Ospedaliera San Gerardo di Monza; Fondazione IRCCS Policlinico San Matteo di Pavia; Treviso Regional Hospital; Ospedale San Bortolo di Vicenza; Azienda Ospedaliero Universitaria di Cagliari; IRCCS Ospedale San Raffaele
• Investigators: Principal Investigator: Alessandra Decataldo, PhD, University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Estimated): September 2, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 24, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Preterm birth; e-Health; Parental well-being; Sociology of Health; Digital-Based Monitoring; Mixed-method Research
• Other Study ID Numbers: 20225R7XB3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No