NCT06931639 Suicide Preventive Psychosocial Treatment for Youths
| NCT ID | NCT06931639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Suicide Attempt |
| Study Type | INTERVENTIONAL |
| Enrollment | 282 participants |
| Start Date | 2025-05-28 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 282 participants in total. It began in 2025-05-28 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06931639 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Suicide Attempt. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931639 currently recruiting?
Yes, NCT06931639 is actively recruiting participants. Contact the research team at lydia.peraza.aguiar@ki.se for enrollment information.
Where is the NCT06931639 trial being conducted?
This trial is being conducted at Helsingborg, Sweden, Karlstad, Sweden, Kungsbacka, Sweden, Stockholm, Sweden and 1 additional location.
Who is sponsoring the NCT06931639 clinical trial?
NCT06931639 is sponsored by Karolinska Institutet. The trial plans to enroll 282 participants.