Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research

NCT06495762 | Not Yet Recruiting

• 1 other identifier: 20225R7XB3
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 6

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.

Conditions

Psychological Distress

Keywords

Preterm birth; Parental well-being; Sociology of Health; Digital-Based Monitoring; Mixed-method Research; e-Health

Outcome Measures

Primary Outcomes (5)

• 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).

Interventions

e-health assesment OTHER

This study is purely observational and does not forsee any intervention but only observational assesment of parents' wellbeing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Catholic University of the Sacred Heart: collaborator
• Treviso Regional Hospital: collaborator
• Ospedale San Bortolo di Vicenza: collaborator
• Azienda Ospedaliero Universitaria di Cagliari: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• IRCCS Ospedale San Raffaele: collaborator
• Azienda Ospedaliera San Gerardo di Monza: collaborator

Study Sites (6)

Dipartimento Materno infantile, Terapia Intensiva Neonatale, Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, CA, 09123, Italy

Location

S.C. Neonatologia e Terapia Intensiva Neonatale, I.R.C.C.S. Ospedale San Gerardo Monza

Monza, MB, 20900, Italy

Location

U.O Neonatologia e Patologia Neonatale, I.R.C.C.S. Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

S.C. Neonatologia e Terapia Intensiva Neonatale, Fondazione IRCCS Policlinico San Matteo di Pavia.

Pavia, PV, 27100, Italy

Location

U.O.C. di Terapia Intensiva Neonatale, patologia neonatale ed assistenza al neonato sano presso il Presidio Ospedaliero di Treviso

Treviso, TV, 31100, Italy

Location

UOSD di Terapia Intensiva e Patologia Neonatale presso l'ospedale di Vicenza (ULSS 8 Berica).

Vicenza, VI, 36100, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Alessandra Decataldo, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Decataldo, PhD

CONTACT

0264487418; alessandra.decataldo@unimib.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 11, 2024
• Study Start: September 2, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)