Clinical trial Recruiting at 4 sites Interventional Ages 10 to 17

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 typeInterventional
Ages10 Years to 17 Years
SexAll
Enrollment282 (estimated)
SponsorKarolinska Institutet
Academic / other
Locations5 sites (Helsingborg and 4 other locations)
StatusRecruiting
StartedMay 28, 2025
Main results expectedSeptember 2027
Study endsSeptember 2032
Registry record updatedOctober 23, 2026
Trial IDNCT06931639 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

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.