Safety planning and transdiagnostic cognitive behavioral therapy for adolescent suicide prevention in Mozambique: study protocol for the SPI/TCBT-S hybrid effectiveness/implementation cluster randomized trial.

Background: More than 75% of suicide deaths occur in low-and middle-income countries (LMICs) and almost 90% of adolescents who die by suicide live in LMICs. Globally, suicide is the fourth leading cause of death for youth aged 15-29. Six of the top 10 countries by suicide rates in the world are in the African region. Despite this, there are few to no evidence-based youth suicide prevention packages developed for, and tested in, the African context. To address this gap, this study aims to test effectiveness and implementation outcomes for the brief Safety Planning Intervention (SPI) and the more resource-intensive multi-session Transdiagnostic Cognitive Behavioral Therapy Intervention for Suicide Prevention (TCBT-S) delivered by non-specialists in Mozambican secondary schools.

Methods: Using a three-arm, parallel, Hybrid Type-1 cluster randomized trial design, we will randomize 7 secondary schools each to Enhanced Usual Care (EUC), SPI alone, and TBCT-S (21 schools total) to evaluate effects on suicidal behaviors (primary) and suicidal ideation/depressive symptoms (secondary). Exploratory structural equation modeling will examine potential mechanisms of intervention effects. Implementation outcomes, barriers, and facilitators to EUC, SPI, and TCBT-S implementation will be assessed using the RE-AIM evaluation and CFIR determinant frameworks. Costs and cost-effectiveness will be evaluated using a Markov model parameterized with cost and trial outcomes data and be applied to projecting budget impact and potential scale-up to provincial and national levels.

Discussion: This study is innovative in being the first, to our knowledge, to rigorously test SPI and TCBT-S for adolescent suicide prevention in Sub-Saharan Africa. By simultaneously testing the brief SPI alone - as well as integrated into a more resource-intensive TCBT-S - this study will examine whether the potential gains in effectiveness with the more resource intensive TCBT-S justify its scale-up versus the brief SPI intervention. If effective, SPI or TCBT-S have a large potential to be rapidly scaled up to safeguard youth mental health in Mozambique and other similar LMICs.

Trial registration: ClinicalTrials.gov; NCT06465381; https://clinicaltrials.gov/study/NCT06465381 .