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Stage 1 Registered report
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Category: Other
Description: Internalising mental health difficulties, characterised by disturbances in mood and/or emotion, significantly impair quality of life, and their prevalence increases significantly during the transition from childhood to adolescence. The objective of this parallel cluster randomised controlled trial was to determine whether a universal, school-based social and emotional learning intervention (Passport: Skills for Life) could reduce internalising symptoms (primary outcome) and related outcomes compared to the usual school curriculum (control). Passport is implemented by trained class teachers, who deliver 18 weekly lessons across 5 modules (emotions; relationships and helping each other; difficult situations; fairness, justice and what is right; and, change and loss). Mainstream primary schools (clusters) were the unit of randomisation. Allocation took place following completion of baseline measures, with minimisation ensuring balance across trial arms in school size and the proportion of children eligible for free school meals. A total of k = 62 schools (N = 2242 children, aged 8-9) were randomly allocated to intervention (Passport; k = XX; N = XXXX [to be reported in Stage 2 submission]) or control (k = YY; N = YYYY [to be reported in Stage 2 submission]) conditions. The trial’s lead data analyst was masked to school allocation, but trial participants, schools, and the remaining authors were not. The intention-to-treat analysis of the primary outcome (internalising symptoms) revealed that control and intervention schools differed by [estimated effect size and its precision to be reported in Stage 2 submission]. Secondary outcome intention-to-treat analyses revealed [estimated effect sizes and their precision to be reported in Stage 2 submission]. [Statement on adverse events to be reported in Stage 2 submission]. [Statement on general interpretation of results to be reported in Stage 2 submission].