Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY): A Randomized Clinical Trial of a Psychosocial Intervention

Suicide is the leading cause of death among 10–18-year-olds in Sweden. Suicide attempt is the most robust predictor of future attempts and suicide. Yet, no evidence-based treatment currently exists for preventing suicide reattempts.

Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable family-based cognitive-behavioural suicide prevention program designed to fill this critical gap. SAFETY has shown promise in reducing suicide attempts.

In the present trial we aim to evaluate the effect of SAFETY on youth suicide attempts by comparing SAFETY to the active control condition “Enhanced Treatment as Usual” in a randomized clinical trial (RCT; N=282), recruiting from five sites across Sweden. The analyses will be conducted on an intention-to-treat basis.

The primary outcome is the difference in the proportion of individuals with a new suicide attempt between the two groups at 3- (primary end-point) and 12-month post-treatment, analyzed using Pearson´s chi-squared test. Patients will be enrolled and treated between 2025 and 2027.

Our initial findings from a feasibility RCT of SAFETY (N=30) in Stockholm indicate that our research protocol, including participant recruitment and treatment conditions, is feasible.

The present study will investigate the impact of SAFETY on suicide attempts, evaluate the durability of the effects, and evaluate the cost-effectiveness of the intervention. The pilot and planning for the RCT have already been partially funded by other sources.