2.8. Adaptation of Study Protocols
The COVID-19 pandemic posed (from March 2020 onwards) considerable challenges to the trial study in all six countries. Largely due to ethical considerations put forward by the project’s International Advisory and Ethics Board (IAEB), namely the possibility to continue to offer support to AYCs during the pandemic via their participation in the ME-WE project, combined with more pragmatic concerns to avoid costly trial closures, deviations from the original study protocol were considered unavoidable by the research team. Amendments to the study protocols were prepared and submitted for approval to competent local ethics committees. To comply with the restrictions and precautionary measures introduced at national levels, the study was virtualised, to include remote enrolment, screening, consent and data collection, as well as a fully online delivery of the ME-WE intervention [Partners amended the original study protocol in the second half of 2020, which involved a few changes to the intervention delivery, while the core contents of the intervention remained the same. Specifically, the fully face-to-face method, planned for Italy, Slovenia and the UK was replaced by online sessions using secure video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g., Zoom, Microsoft Teams). In addition, the prior “blended delivery approach” in use in Sweden, Switzerland and the Netherlands and including a combination of face-to-face and online sessions supported by an app developed ad hoc for the project and co-designed with AYCs was replaced solely by online meetings using the ME-WE mobile app and supported with the Zoom video-conferencing system.