Efficacy of a school-based, universal prevention programme for depression and anxiety in adolescents (OurFutures Mental Health): a two-arm cluster-randomised controlled trial.

Abstract

Adolescence is a critical period for the onset of mental health challenges. We evaluated the efficacy of a school-based intervention (<i>OurFutures Mental Health)</i> in promoting mental health knowledge and preventing symptoms of depression and anxiety. A two-arm cluster-randomised controlled trial was conducted from 2023 to 2024 with Year 8/9 students from 10 secondary schools in Australia. Schools were randomised (1:1) to the <i>OurFutures Mental Health</i> intervention or active control (usual health education) using the <i>Blockrand</i> function in R by an external statistician. Eligible participants were Year 8/9 students enrolled at participating schools. <i>OurFutures Mental Health</i> is a six-lesson, trauma-informed and gender- and sexuality-affirming intervention, employing a cognitive-behavioural approach. The three, pre-registered primary outcomes were mental health knowledge and depressive and anxiety symptoms at 3-months post-baseline. Linear mixed-effects regression models were run on the intention to treat sample, with random intercepts for participants and schools, tested whether receiving the intervention improved knowledge and reduced depression and anxiety symptoms relative to active control. The trial was registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12622001582741. Between Dec 6, 2022 and April 12, 2024, we recruited 17 schools (1785 students), of which 10 schools (784 students) participated in the baseline assessment (mean age = 13.8 years; 467 [59.6%] male; intervention: 6 schools, 497 students; control: 4 schools, 287 students). Seven schools withdrew prior to baseline (6 control; 1 intervention). Knowledge scores were significantly higher in the intervention group post-intervention, but not at 3 months (β = 0.30, 95% CI: -0.32-0.91, p = 0.34). No significant intervention effects were observed for depressive symptoms at 3-months (β = -0.94, 95% CI: -1.88 to 0.04, p = 0.055). However, the intervention group showed a greater reduction in anxiety symptoms at 3-month follow-up compared to active control (β = -1.05, 95% CI: -1.93 to -0.12, p = 0.024). No adverse events were reported. <i>OurFutures Mental Health</i> may be an efficacious intervention to improve mental health knowledge and prevent anxiety symptoms among adolescents in the short-term. Limitations of this trial include high participant attrition and withdrawal of several schools post-randomisation, limiting generalisability. The trial was also underpowered, limiting detection of smaller intervention effects. Further research is needed to improve efficacy for prevention of depression. Paul Ramsay Foundation.