Preventing suicide with Safe Alternatives for Teens and Youths (SAFETY): a randomised feasibility trial.

Abstract

Background: Suicide attempts are common in youth and have potentially lethal outcomes. Effective treatments targeting suicide attempts are scarce.

Objective: To assess the feasibility and preliminary efficacy of a family-based cognitive behavioural treatment relative to an active control for youth with suicidal behaviour.

Methods: 30 youths (93% female; mean (SD) age=14.6 (1.5) years) residing in Sweden with recent suicidal behaviour (last 3 months) and at least one available parent were randomised to 12 weeks of the family-based cognitive behavioural treatment Safe Alternatives for Teens and Youths (SAFETY) or supportive therapy, an active control treatment. Primary endpoint was 3-month post-treatment. Feasibility outcomes included treatment and assessment compliance, adverse events, treatment credibility and treatment satisfaction. Secondary outcomes included suicide attempt, non-suicidal self-injury, anxiety, depression, quality of life and emotion dysregulation.

Findings: Both treatments showed high compliance, satisfaction, credibility and session completion, with few adverse events and dropouts as well as low attrition (7% at primary endpoint). At the primary endpoint, two (14%) participants in SAFETY and four (27%) in supportive therapy had attempted suicide. Non-suicidal self-injury was reduced by 95% (incidence rate ratio=0.05 (95% CI 0.01 to 0.20)) in SAFETY and 69% (incidence rate ratio=0.31 (0.11 to 0.83)) in supportive therapy. Participation in SAFETY, but not in supportive therapy, was associated with moderate-to-large within-group improvements in anxiety and depression (Cohen's d=0.85 [0.33 to 1.40]), quality of life (d=1.01 [0.48 to 1.56]) and emotion dysregulation (d=1.22 [0.45 to 2.03]).

Conclusions: The results suggest that SAFETY is feasible and promising for youth with suicidal behaviour.

Clinical implications: A large randomised controlled trial is warranted to further examine the efficacy of SAFETY.

Trial registration number: NCT05537623.