Psychological Distresse-ParWelBNCT06495762
Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research
An observational study of Psychological Distress, run by University of Milano Bicocca at 6 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- e-health assesment
- How many people
- 350 participants
- Where
- 6 sitesItaly
- Study dates
- 2 Sep 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of preterm child who were born in one of the partner NICU during the monitoring phase of the project.
Who may be able to join
- 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.
Who cannot join
- Children must not have other genetic pathologies or other pathologies not linked to the preterm birth.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Dipartimento Materno infantile, Terapia Intensiva Neonatale, Azienda Ospedaliero-Universitaria di Cagliari
Cagliari, CA, 09123
Vassilios Fanos, 07051093403 ext. +39, vafanos@tiscali.it
U.O Neonatologia e Patologia Neonatale, I.R.C.C.S. Ospedale San Raffaele
Milan, MI, 20132
Antonella Poloniato, 02 26432623, poloniato.antonella@hsr.it
S.C. Neonatologia e Terapia Intensiva Neonatale, I.R.C.C.S. Ospedale San Gerardo Monza
Monza, MB, 20900
Maria Luisa Ventura, 030392331 ext. +39, marialuisa.ventura@irccs-sangerardo.it
S.C. Neonatologia e Terapia Intensiva Neonatale, Fondazione IRCCS Policlinico San Matteo di Pavia.
Pavia, PV, 27100
Camilla Pisoni, 0382502518 ext. +39, pisoni.camilla@gmail.com
U.O.C. di Terapia Intensiva Neonatale, patologia neonatale ed assistenza al neonato sano presso il Presidio Ospedaliero di Treviso
Treviso, TV, 31100
Paola Lago, 0422322263 ext. +39, paola.lago@aulss2.veneto.it
UOSD di Terapia Intensiva e Patologia Neonatale presso l'ospedale di Vicenza (ULSS 8 Berica).
Vicenza, VI, 36100
About this study
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- e-health assesment
- Keywords
- Preterm birth, Parental well-being, Sociology of Health, Digital-Based Monitoring, Mixed-method Research, e-Health
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-health assesmentOther
This study is purely observational and does not forsee any intervention but only observational assesment of parents' wellbeing
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start2 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Alessandra Decataldo, University of Milano Bicocca
- Investigators
- Alessandra Decataldo, PhD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495762
- Sponsor's protocol ID
- 20225R7XB3
- Acronym
- e-ParWelB
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Premature Family Maladjustment: an e-Health Interdisciplinary Research
- ClinicalTrials.gov ID
- NCT06495762
- Acronym / sponsor ID
- e-ParWelB / 20225R7XB3
- Conditions
- Psychological Distress
- Keywords
- Preterm birth, Parental well-being, Sociology of Health, Digital-Based Monitoring, Mixed-method Research, e-Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- 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
- Study start
- 2 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of preterm child who were born in one of the partner NICU during the monitoring phase of the project.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Children must not have other genetic pathologies or other pathologies not linked to the preterm birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-health assesmentThis study is purely observational and does not forsee any intervention but only observational assesment of parents' wellbeing | Other | – |
Primary outcome
Postpartum Anxiety
Time frame: 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).
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).
Post-partum PTSD
Time frame: 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).
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).
Post-partum depression
Time frame: 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).
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.
Post-partum parent-child bonding
Time frame: The scale is administered once, the day of child discharge from NICU (starting from 01/09/2024 to 28/02/2025).
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).
Parenting-related stress
Time frame: 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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Decataldo, PhD principal investigator
University of Milano Bicocca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress, run by University of Milano Bicocca at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Decataldo, PhD (0264487418 ext. +39, alessandra.decataldo@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Anxiety (time frame: 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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.