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Recruiting Not applicable NCT06931639

Suicide Preventive Psychosocial Treatment for Youths

No applicable phase (e.g. observational)
Conditions: Suicide Attempt Suicidal and Self-injurious Behavior Suicide Attempted Suicide, Attempted

Sponsor: Karolinska Institutet

trial.available_in: БГ
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.
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.
Who can participate
Inclusions criteria: 1. Suicide attempt in the last 3 months 2. Age 10-17 years 3. At least one primary caregiver (multiple is allowed) willing to participate in treatment Exclusion criteria: 1. Symptoms obstructing participation in assessments or treatment 2. Insufficient understanding of the Swedish language in youth and/or caregiver 3. Enrolled in Dialectical Behavioral Therapy
Interventions
Safe Alternatives for Teens and Youth (SAFETY)
BEHAVIORAL
Enhanced Treatment As Usual
BEHAVIORAL
Locations 5
Sweden (5)
Child and Adolescent Mental Health Services, Region Skåne
Helsingborg
Eva Serlachius, MD, PhD
Child and Adolescent Psychiatry, Region Värmland
Karlstad
NOT_YET_RECRUITING
Maria Unenge Hallerbäck, MD, Ph.D.
Child and Adolescent Mental Health Services, Region Halland
Kungsbacka
Anna Santesson, MD, PhD
Child and Adolescent Mental Health Services, Region Stockholm
Stockholm
Anna Ohlis, MD, PhD
Child and Adolescent Psychiatry, Region Uppsala
Uppsala
Mia Ramklint, MD, PhD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
10 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
28.05.2025
Completion date
01.09.2032
Registry ID
NCT06931639
Source
clinicaltrials.gov
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