Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495762
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-24
Brief Title:
Preventing Premature Family Maladjustment an e-Health Interdisciplinary Research
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
Preventing Premature Family Maladjustment an e-Health Interdisciplinary Research
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
e-ParWelB
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 babys 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 childs 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 childs 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 estimandestimator 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
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 estimandestimator 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None