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

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.