Suicide Preventive Psychosocial Treatment for Youths
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Safe Alternatives for Teens and Youth (SAFETY), Enhanced Treatment As Usual.
- Who it may be relevant to
- Registry conditions: Suicide Attempt, Suicidal and Self-injurious Behavior, Suicide Attempted, Suicide, Attempted. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
Overview
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.
Detailed description
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 single-blind randomized controlled multisite superiority trial.
PRIMARY OBJECTIVE To determine the clinical efficacy of SAFETY for reducing suicide re-attempt in youths with a recent suicide attempt, compared with enhanced treatment as usual within child and adolescent mental health care (E-TAU). The primary endpoint is the follow-up 3 months post-treatment.
SECONDARY OBJECTIVES
1. To determine the clinical efficacy of SAFETY for nonsuicidal self-injury, global functioning, anxiety, depression, and hopelessness in youths with a recent suicide attempt, compared with E-TAU. The primary endpoint is the follow-up 3 months post-treatment. 2. To evaluate the clinical efficacy of SAFETY for a composite outcome of suicide attempts and nonsuicidal self-injury, in order to enable comparison with other studies. 3. To establish the 12-month durability of the treatment effects. 4. To conduct a health-economic evaluation of SAFETY for youth with a recent suicide attempt, compared with E-TAU, from multiple perspectives, both in the short term (primary endpoint) and the long term (12-month follow-up). 5. To test predictors and moderators of treatment effect, including factors related to baseline levels of the outcomes, comorbidity, personality, family functioning, parental factors, school experience, peer support, and traumatic experiences. 6. Test whether emotion regulation, thwarted belongingness and perceived burdensomeness, parental invalidation, and family functioning mediate treatment outcome. 7. Long-term follow-up from post-treatment to 60-month post-treatment including patient-reports and parent-reports, as well as psychiatric disorders, clinical care consumption, pharmacological prescriptions, employment status, and academic performance retrieved from registries.
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).
Primary outcome measures
- Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
Secondary outcome measures (8)
- Nonsuicidal self-injury - any report from The Deliberate Self Harm Inventory - Youth version (DSHI-Y) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Work and Social Adjustment Scale, youth version (WSAS-Y) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Children's global assessment scale (CGAS) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Beck's Hopelessness Scale (BHS) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Child Health Utility 9D (CHU-9D) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Recovering Quality of Life (ReQoL) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P) [Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
Eligibility criteria
Inclusions criteria:
- Suicide attempt in the last 3 months
- Age 10-17 years
- At least one primary caregiver (multiple is allowed) willing to participate in treatment
Exclusion criteria
- Symptoms obstructing participation in assessments or treatment
- Insufficient understanding of the Swedish language in youth and/or caregiver
- Enrolled in Dialectical Behavioral Therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 5 centers
- Child and Adolescent Mental Health Services, Region Skåne — Helsingborg
- Child and Adolescent Psychiatry, Region Värmland — Karlstad
- Child and Adolescent Mental Health Services, Region Halland — Kungsbacka
- Child and Adolescent Mental Health Services, Region Stockholm — Stockholm
- Child and Adolescent Psychiatry, Region Uppsala — Uppsala
Identifiers
NCT: NCT06931639 · SAFETYRCT2025 · 2024-00196