NCT05537623

Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)

Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Region Stockholm · Other Government
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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?

Conditions

• Suicide and Self-harm

Interventions

Type	Name	Description
BEHAVIORAL	Safe Alternatives for Teens and Youths (SAFETY)	Please see description of experimental arm (arm one)
BEHAVIORAL	Supportive Therapy	Please see description of active comparator arm (arm two)

Timeline

• Start date: 2022-12-02
• Primary completion: 2024-05-13
• Completion: 2025-02-13
• First posted: 2022-09-13
• Last updated: 2025-04-11

Locations

1 site across 1 country: Sweden