Clinical Trial

Suicide Preventive Psychosocial Treatment for Youths

Recruiting
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Summary
Suicide is the leading cause of death amongst 10-18-year-olds in Sweden. Suicide attempts are the strongest predictor of subsequent death by suicide, often lead to inpatient care, and are associated with substantial societal costs, making suicide attempts a critical target in psychiatric intervention research. Although youths attempting suicide are typically assessed and treated for potential comorbid psychiatric conditions, there is currently no trans-diagnostic evidence-based treatment specifically targeting suicidal behavior. To fill this gap, the Safe Alternatives for Teens and Youths (SAFETY) was developed. SAFETY is a transdiagnostic family-based cognitive-behavioral suicide prevention program that has shown promise but more studies are needed. The overall objective of this project is to evaluate the efficacy, durability, and cost-effectiveness of the SAFETY intervention, a scalable suicide prevention intervention that can be offered immediately following a youth suicide attempt, in a fully powered single-blind randomized controlled superiority trial. Our primary hypothesis is that the SAFETY intervention will be superior to Enhanced Treatment As Usual (enhanced with the evidence-based intervention safety planning) in reducing the proportion of suicide reattempts. Moreover, we predict that these improvements will be maintained for up to 60 months post-treatment. Finally, we expect that SAFETY will be cost-effective compared to the control intervention, both at the primary endpoint and in the longer term.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-18
Trial Details
NCT Number NCT06931639
Lead Sponsor Karolinska Institutet
Conditions Suicide Attempt, Suicidal and Self-injurious Behavior, Suicide Attempted, Suicide, Attempted
Enrollment 282 participants
Start Date 2025-05-28
Primary Completion 2027-09 (estimated)
Study Completion 2032-09 (estimated)
Updated on ClinicalTrials.gov 2026-04-17