Currently accepted at: JMIR Research Protocols
Date Submitted: Jun 9, 2026
Open Peer Review Period: Jun 10, 2026 - Aug 5, 2026
Date Accepted: Sep 29, 2026
(closed for review but you can still tweet)
This paper has been accepted and is currently in production.
It will appear shortly on 10.2196/104182
The final accepted version (not copyedited yet) is in this tab.
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Connecting families to improve parental self-efficacy and parent psychosocial and infant health outcomes in the NICU using an eHealth solution: the CONNECT Study Protocol
ABSTRACT
Background:
Parents of infants admitted to the neonatal intensive care unit (NICU) frequently experience high levels of psychological distress, including anxiety, depression and reduced parental self-efficacy. These challenges can negatively affect parent–infant bonding, parental engagement in care and longer-term infant and family outcomes. Digital health solutions offer a scalable opportunity to provide tailored psychosocial support, enhance parental confidence, and improve family-centered care within the NICU context. Although increased parenting self-efficacy is associated with improved psychosocial health for parents and better outcomes for infants, no studies have been adequately powered to determine effective interventions aimed at enhancing parental self-efficacy for families with infants requiring NICU care. The CONNECT Study is designed to evaluate the effectiveness and implementation of a structured health solution aimed at improving parenting self-efficacy, psychosocial outcomes and infant health outcomes.
Objective:
The primary objective is to evaluate the effectiveness of Chez NICU Home + (CNH+) eHealth tool with standard care (vs. care alone) to enhance parental self-efficacy at NICU discharge.
Methods:
This study is a Hybrid-1 multicentre stepped-wedge cluster randomized controlled trial (SWC-RCT) across four Canadian NICUs. Following ethical approval, baseline data on current care practices are to be collected across sites. Following baseline data collection, every five months one of the sites will transition into the intervention phase by implementing an eHealth solution called Chez NICU Home® (CNH), a platform which provides web-based, parent-targeted educational tools, virtual communication, and text message support throughout their infant’s NICU stay. A total of 600 parents (300 per arm) and their infants, who are expected to stay at least 14 days in the NICU, will be recruited to detect a 0.60 SD difference (MD of 6.52 points) from pre-post intervention on the Perceived Maternal Parenting Self-Efficacy (PMPS-E) (80% power and alpha of 0.05 and ICC 0.1 for clustering at site levels). Secondary outcomes include parental psychosocial and infant health outcomes. Implementation effectiveness outcomes include adoption, fidelity, penetration, feasibility, acceptability, satisfaction, appropriateness, sustainment and cost. Findings will be disseminated through peer-reviewed publications and stakeholder engagement.
Results:
The study is currently enrolling with anticipated recruitment to be complete by Spring 2027.
Conclusions:
The CONNECT Study protocol outlines a pragmatic, scalable approach to supporting families in the NICU through an integrated health solution. If effective, this intervention may contribute to improved parenting self-efficacy, psychosocial and health outcomes for parents, infants, and enhanced family-centred care practices in neonatal settings Clinical Trial: ClinicalTrials.gov, NCT05853666, https://clinicaltrials.gov/study/NCT05853666
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.