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Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
Suicide is the leading cause of death in the age span 10-19 years in Sweden. The most robust predictor of future suicide attempt and suicide death is prior suicide attempt. Yet, most youths presenting with suicidal behavior to the Child and Adolescent Mental Health Services (CAMHS) in Stockholm, Sweden are not offered evidence-based care directly targeting suicide risk. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap. SAFETY is a cognitive behavioral family treatment incorporating elements from Dialectical Behavior Therapy and Multisystemic Therapy. SAFETY has shown promise in reducing suicide attempts in two small-N trials. In a randomized controlled feasibility trial, the investigators will examine the feasibility of SAFETY and an active control condition named Supportive Therapy at post-treatment, 3 and 12 months after treatment on youth suicidal behavior. Evaluations of feasibility, acceptability, and safety based on data from this pilot trial will guide and inform the design of a full-scale randomized controlled trial.
Research questions: 1. Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS? 2. Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS? 3. Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible? 4. What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively? 5. Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)? 6. Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)? 7. How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?
Age
10 - 17 years
Sex
ALL
Healthy Volunteers
No
Stockholm Regional Council
Stockholm, Stockholm County, Sweden
Start Date
December 2, 2022
Primary Completion Date
May 13, 2024
Completion Date
February 13, 2025
Last Updated
April 11, 2025
30
ACTUAL participants
Safe Alternatives for Teens and Youths (SAFETY)
BEHAVIORAL
Supportive Therapy
BEHAVIORAL
Lead Sponsor
Region Stockholm
Collaborators
Data Source & Attribution
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