Role of resilience in the pilot cluster randomized controlled trial on school-based group interventions for preventing adolescents’ anxiety and depression in Nepal: Statistical Analysis Plan (SAP)

Despite depression and anxiety being the leading causes of disease burden among young people globally, there is a lack of evidence on effective prevention strategies for adolescent depression and anxiety in low- and middle-income countries (LMICs), where 90% of the world's adolescent population resides. As a part of the ALIVE research project (Lund et al., 2023), the ALIVE pilot trial intends to pilot interventions that focus both on reducing the impact of poverty and on addressing depression and anxiety in three low-resource settings, including Nepal. The ALIVE selective prevention intervention for depression and anxiety intervenes on both poverty and self-regulation among adolescents living in urban poverty. Overall, the pilot ALIVE cluster Randomised Controlled Trial (cRCT) evaluates the feasibility and acceptability of intervention and research procedures before engaging in a fully-powered cRCT. Despite growing evidence on the benefits of psychosocial interventions for youth in low- and middle-income countries (LMICs), there remains limited understanding of how these interventions reduce mental health symptoms like depression and anxiety (Morina et al., 2017; Purgato et al., 2018). To strengthen intervention design, it is essential to explore mediators, particularly resilience, defined as the dynamic process enabling positive outcomes despite adversity (Tol et al., 2008; Betancourt et al., 2013). Ecological resilience is a key framework in psychosocial interventions, emphasizing dynamic interactions between risk, protective, and promotive factors across individual, family, and community levels (Betancourt et al., 2013; Ungar, 2012; Ungar et al., 2013; Tol et al., 2013). It supports children’s adaptive development in adversity by enhancing feelings of safety, coping, hope and social support, shifting focus from deficits to strengths for improved psychological well-being (Wessels, 2015; Wessels, 2018). Mediation analyses of 11 RCTs (Purgato et al., 2018) suggest that focused psychosocial support improves coping, hope, and social support—core elements of resilience, which may in turn reduce psychological symptoms. Rooted in ecological resilience theory, this approach emphasizes shifting from a clinical-deficit model to a strengths-based model that harnesses adolescents' capacity to navigate resources (both external and internal) to cope with adversity, underlining resilience as a key pathway of change. The current study aims to test an ecological resilience pathway for the ALIVE interventions. We hypothesize that the ALIVE interventions lead to an increased resilience (internal and external), which in turn reduces adolescent depressive and anxiety symptoms. In this study, resilience refers to both an individual trait and a product of the environmental support systems that help an individual to endure adversities (Ungar, 2011; Jefferies et al., 2019; Jefferies et al., 2022). This is a statistical analysis plan (SAP) for our study embedded within a larger research project (ALIVE pilot cRCT). While data collection for the baseline and post-intervention phases has been completed, the 12-month follow-up is yet to be completed. This SAP describes the planned statistical methods and analyses to be used.