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dc.contributor.authorLoughnan, Siobhan A
dc.contributor.authorBoyle, Frances M
dc.contributor.authorEllwood, David
dc.contributor.authorCrocker, Sara
dc.contributor.authorLancaster, Ann
dc.contributor.authorAstell, Chrissie
dc.contributor.authorDean, Julie
dc.contributor.authorHorey, Dell
dc.contributor.authorCallander, Emily
dc.contributor.authorJackson, Claire
dc.contributor.authorShand, Antonia
dc.contributor.authorFlenady, Vicki
dc.date.accessioned2022-11-24T04:53:10Z
dc.date.available2022-11-24T04:53:10Z
dc.date.issued2022
dc.identifier.issn1745-6215en_US
dc.identifier.doi10.1186/s13063-022-06363-0en_US
dc.identifier.urihttp://hdl.handle.net/10072/419693
dc.description.abstractBackground: Stillbirth and neonatal death are devastating pregnancy outcomes with long-lasting psychosocial consequences for parents and families, and wide-ranging economic impacts on health systems and society. It is essential that parents and families have access to appropriate support, yet services are often limited. Internet-based programs may provide another option of psychosocial support for parents following the death of a baby. We aim to evaluate the efficacy and acceptability of a self-guided internet-based perinatal bereavement support program “Living with Loss” (LWL) in reducing psychological distress and improving the wellbeing of parents following stillbirth or neonatal death. Methods: This trial is a two-arm parallel group randomized controlled trial comparing the intervention arm (LWL) with a care as usual control arm (CAU). We anticipate recruiting 150 women and men across Australia who have experienced a stillbirth or neonatal death in the past 2 years. Participants randomized to the LWL group will receive the six-module internet-based program over 8 weeks including automated email notifications and reminders. Baseline, post-intervention, and 3-month follow-up assessments will be conducted to assess primary and secondary outcomes for both arms. The primary outcome will be the change in Kessler Psychological Distress Scale (K10) scores from baseline to 3-month follow-up. Secondary outcomes include perinatal grief, anxiety, depression, quality of life, program satisfaction and acceptability, and cost-effectiveness. Analysis will use intention-to-treat linear mixed models to examine psychological distress symptom scores at 3-month follow-up. Subgroup analyses by severity of symptoms at baseline will be undertaken. Discussion: The LWL program aims to provide an evidence-based accessible and flexible support option for bereaved parents following stillbirth or neonatal death. This may be particularly useful for parents and healthcare professionals residing in rural regions where services and supports are limited. This RCT seeks to provide evidence of the efficacy, acceptability, and cost-effectiveness of the LWL program and contribute to our understanding of the role digital services may play in addressing the gap in the availability of specific bereavement support resources for parents following the death of a baby, particularly for men. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12621000631808. Registered prospectively on 27 May 2021.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.publisherBMCen_US
dc.relation.ispartofpagefrom464en_US
dc.relation.ispartofjournalTrialsen_US
dc.relation.ispartofvolume23en_US
dc.subject.keywordsScience & Technologyen_US
dc.subject.keywordsLife Sciences & Biomedicineen_US
dc.subject.keywordsMedicine, Research & Experimentalen_US
dc.subject.keywordsResearch & Experimental Medicineen_US
dc.subject.keywordsStillbirthen_US
dc.titleLiving with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal deathen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationLoughnan, SA; Boyle, FM; Ellwood, D; Crocker, S; Lancaster, A; Astell, C; Dean, J; Horey, D; Callander, E; Jackson, C; Shand, A; Flenady, V, Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death, Trials, 2022, 23, pp. 464en_US
dcterms.dateAccepted2022-04-26
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/en_US
dc.date.updated2022-11-24T04:50:17Z
dc.description.versionVersion of Record (VoR)en_US
gro.rights.copyright© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.en_US
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gro.griffith.authorEllwood, David A.


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