SAFETY family-based program for youths after a suicide attempt
Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
This project will test whether the SAFETY family-based therapy helps 10-17-year-olds who recently attempted suicide avoid repeat attempts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 282 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 5 sites (Helsingborg and 4 other locations) |
| Trial ID | NCT06931639 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: SAFETY has shown promise in earlier work, but rigorous randomized multisite evidence for its effectiveness and cost-effectiveness is still needed.
Eligibility criteria
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 this trial is running
Helsingborg and 4 other locations
- Child and Adolescent Mental Health Services, Region Skåne — Helsingborg, Sweden (Recruiting)
- Child and Adolescent Psychiatry, Region Värmland — Karlstad, Sweden (Not_yet_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)
Study contacts
- Study coordinator: Lydia Peraza Aguiar, MSc
- Email: lydia.peraza.aguiar@ki.se
- Phone: +46735170963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.