Title	Living with Loss: Study protocol for a randomised controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death
Trial registration	Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12621000631808, registered prospectively on 27/05/2021 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381231&isReview=true. ANZCTR collects and publicly displays the WHO Trial Registration Data Set.
Protocol version	14th March 2022; version 1.1
Funding	The Living with Loss project is supported by the Australian Government’s Medical Research Future Fund (MRFF) Rapid Applied Research Translation program grant awarded to Health Translation Queensland (formerly Brisbane Diamantina Health Partners; BDHP).
Author affiliations	1NHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane QLD AUSTRALIA 2Institute for Social Science Research, The University of Queensland, 80 Meiers Rd, Indooroopilly QLD AUSTRALIA 3School of Medicine, Griffith University, Parklands Drive; 4Gold Coast University Hospital, 1 Hospital Drive, Southport QLD AUSTRALIA 5La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC AUSTRALIA 6Monash University, 553 St Kilda Road, Melbourne VIC AUSTRALIA 7The University of Queensland, St Lucia QLD AUSTRALIA 8Faculty of Medicine and Health, The University of Sydney, Camperdown NSW AUSTRALIA
Name and contact information for the trial sponsor	Funding is administered by The University of Queensland for Health Translation Queensland (formerly Brisbane Diamantina Health Partners) and sub-contracted to the Centre of Research Excellence in Stillbirth (Stillbirth CRE), Mater Research Institute-University of Queensland. Research office located at: Cumbrae Stewart building 72, St Lucia campus, Brisbane Queensland Australia; Phone: +61 7 3365 3560
Role of sponsor	The sponsor has no role in the design of this study and will not have any role during its execution, analyses, interpretation of data, or decision to submit results.
Composition, roles and responsibilities	Coordinating centre and data management team: The Centre of Research Excellence in Stillbirth (Stillbirth CRE), Mater Research Institute-University of Queensland based in Brisbane Queensland Australia is responsible for the overarching conduct and coordination of this study. The coordinating research team (SL, SC, AL, CA, FB, DE, VF) are based at the Stillbirth CRE and are responsible for the day-to-day conduct of the study including participant monitoring and data management. Steering committee: An advisory group has been established to oversee and review conduct of this study with meetings scheduled every three months, and monthly updates provided via email correspondence. This steering group includes bereaved parents, health care professionals, clinicians, researchers, and parent support and advocacy organisations. The role of this group is to provide specialist knowledge of perinatal bereavement care and mental health, lived experience of perinatal loss, and trial support and advice throughout all stages of the study, including development, evaluation, and dissemination of findings.