Trials. 2025 Sep 24;26(1):351. doi: 10.1186/s13063-025-09118-9.
ABSTRACT
BACKGROUND: This update outlines amendments to the MAPSS trial protocol in response to both the COVID-19 pandemic and broader feasibility considerations. While many changes were necessary to navigate pandemic-related disruptions-such as school closures and remote learning-others were made to improve feasibility in the school-based setting, independent of COVID-19. The protocol was updated to align with public health guidelines and general school practices, ensuring feasibility for continued school participation and increased support and flexibility for school communities.
METHODS: Key adjustments included changes to participant-facing documentation, including implementing digital consent processes, extending timelines for participant recruitment and participation, and enhancing remote engagement strategies. Modifying outcome measures and risk management protocols, including adverse event reporting, ensured both participant safety and data continuity. Lastly, new study measures were added, such as a custom-designed questionnaire to assess study acceptability. Despite the updates, the core trial design, eligibility criteria, and primary outcomes remained unchanged.
CONCLUSION: These protocol amendments reflect the pragmatic challenges of conducting school-based mental health research during a global pandemic and as part of ongoing efforts to enhance feasibility. The adjustments enabled the trial to proceed safely, prioritizing participant engagement and maintaining alignment with public health measures.
TRIAL REGISTRATIONS: Australian New Zealand Clinical Trial Registry, ACTRN12621000279820, originally registered on 12 March 2021, and currently awaiting update approval. Australian New Zealand Clinical Trial Registry, ACTRN12621000770864, originally registered on 21st June 2021, and updated on 16th February 2025.
PMID:40993694 | DOI:10.1186/s13063-025-09118-9
