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RECRUITING
NCT06931639
NA

Suicide Preventive Psychosocial Treatment for Youths

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Official title: Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

282

Start Date

2025-05-28

Completion Date

2032-09

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

BEHAVIORAL

Safe Alternatives for Teens and Youth (SAFETY)

Please see description of experimental arm (arm one)

BEHAVIORAL

Enhanced Treatment As Usual

Please see description of active comparator arm (arm two).

Locations (5)

Child and Adolescent Mental Health Services, Region Skåne

Helsingborg, Sweden

Child and Adolescent Psychiatry, Region Värmland

Karlstad, Sweden

Child and Adolescent Mental Health Services, Region Halland

Kungsbacka, Sweden

Child and Adolescent Mental Health Services, Region Stockholm

Stockholm, Sweden

Child and Adolescent Psychiatry, Region Uppsala

Uppsala, Sweden