SAFETY family-based program for youths after a suicide attempt
Official title: Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
Run by Karolinska Institutet · NCT06931639 · Data updated 2026-11-12
This project will test whether the SAFETY family-based therapy helps 10-17-year-olds who recently attempted suicide avoid repeat attempts.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 17 Years |
| Sex | All |
| Enrollment | 282 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 5 sites (Helsingborg and 4 other locations) |
| Status | Recruiting |
| Started | May 28, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2032 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06931639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 10–17-year-olds who made a suicide attempt within the past 3 months and have at least one caregiver willing to participate and understand Swedish.
✕Probably not a fit
Patients with symptoms that obstruct participation, insufficient Swedish language comprehension, or those already enrolled in Dialectical Behavior Therapy are unlikely to benefit from joining this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-blind, randomized, multisite superiority trial comparing the SAFETY transdiagnostic family-based cognitive-behavioral program to enhanced treatment as usual for youths aged 10–17 who have attempted suicide within the past 3 months. Participants and at least one caregiver receive the SAFETY intervention soon after the attempt, with the primary endpoint at 3 months post-treatment and a 12-month follow-up to assess durability. Outcomes include suicide re-attempts (primary), nonsuicidal self-injury, global functioning, anxiety, depression, hopelessness, a composite self-harm outcome, and health-economic analyses. The trial will also test predictors and moderators of treatment effect to guide targeting and scale-up.
Why it matters
Potential benefit: If successful, SAFETY could reduce repeat suicide attempts and related inpatient care among teens and provide a scalable family-based prevention option.
How similar studies have gone: SAFETY has shown promise in earlier work, but rigorous randomized multisite evidence for its effectiveness and cost-effectiveness is still needed.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Child and Adolescent Mental Health Services, Region Skåne
Helsingborg, Sweden Recruiting -
Child and Adolescent Mental Health Services, Region Halland
Kungsbacka, Sweden Recruiting -
Child and Adolescent Mental Health Services, Region Stockholm
Stockholm, Sweden Recruiting -
Child and Adolescent Psychiatry, Region Uppsala
Uppsala, Sweden Recruiting -
Child and Adolescent Psychiatry, Region Östergötland
Linköping, Sweden Not yet recruiting
Study contacts
- Study coordinator: Lydia Peraza Aguiar, MSc
- Email: lydia.peraza.aguiar@ki.se
- Phone: +46735170963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.