Suicide Preventive Psychosocial Treatment for Youths

NCT ID: NCT06931639

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2032-09-30

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.

Detailed 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 (as measured by the masked assessor-administered C-SSRS) 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.

Conditions

Suicide Attempt; Suicidal and Self-injurious Behavior; Suicide Attempted; Suicide, Attempted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Safe Alternatives for Teens and Youth (SAFETY)

SAFETY is a transdiagnostic cognitive-behavioral family treatment informed by Dialectical Behavior Therapy (DBT) and Multisystemic Therapy (MST). The twelve week long treatment is principle based, structured in phases, and individually tailored based on a cognitive-behavioral fit analysis that specifies key risk and protective processes. Each session contains one individual component for youth and parents respectively, and one family component where youth and parents work together with therapists to practice skills identified as critical for preventing future suicidal behavior. Treatment targets are arranged in a SAFETY Pyramid, consisting of (a) safe settings; (b) safe people; (c) safe activities and actions; (d) safe thought; and (e) safe stress reactions, emphasizing strengthening protective support and validation within the family and/or social environment surrounding the youth.

Group Type: EXPERIMENTAL

Safe Alternatives for Teens and Youth (SAFETY)

Intervention Type: BEHAVIORAL

Please see description of experimental arm (arm one)

Enhanced Treatment As Usual

Enhanced Treatment As Usual (ETAU) consists of treatment as usual delivered by community clinicians enhanced by the evidence-informed Stanley-Brown Safety Planning Intervention, adapted for adolescents (e.g. involving both youth and parents) and to a Swedish context by the Swedish Association for Child and Adolescent Psychiatry and supervised by the research group. The adapted Safety Planning intervention include an assessment of current and future risk and protective factors for suicide, current and future suicide risk, and an individualized safety plan. We will ensure that the control intervention Safety Planning is delivered in a safe and comparable way across regions. Patients in both conditions will have access to standard care (including pharmaceutical treatment), as well as inpatient care as deemed necessary. The level of standard care will be carefully measured throughout the trial and included in statistical sensitivity analyses.

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment As Usual

Intervention Type: BEHAVIORAL

Please see description of active comparator arm (arm two).

Interventions

Safe Alternatives for Teens and Youth (SAFETY)

Please see description of experimental arm (arm one)

Intervention Type: BEHAVIORAL

Enhanced Treatment As Usual

Please see description of active comparator arm (arm two).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Johan Bjureberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Child and Adolescent Mental Health Services, Region Skåne

Helsingborg, , Sweden

Site Status: NOT_YET_RECRUITING

Child and Adolescent Psychiatry, Region Värmland

Karlstad, , Sweden

Site Status: NOT_YET_RECRUITING

Child and Adolescent Mental Health Services, Region Halland

Kungsbacka, , Sweden

Site Status: NOT_YET_RECRUITING

Child and Adolescent Mental Health Services, Region Stockholm

Stockholm, , Sweden

Site Status: RECRUITING

Child and Adolescent Psychiatry, Region Uppsala

Uppsala, , Sweden

Site Status: NOT_YET_RECRUITING

Countries

Sweden

Central Contacts

Lydia Peraza Aguiar, MSc

Role: CONTACT

lydia.peraza-aguiar@regionstockholm.se

+46735170963

Moa Karemyr, MSc

Role: CONTACT

moa.karemyr@ki.se

+46723950443

Facility Contacts

Eva Serlachius, MD, PhD

Role: primary

eva.serlachius@med.lu.se

Maria Unenge Hallerbäck, MD, PhD

Role: primary

maria.unenge.hallerback@regionvarmland.se

Anna Santesson, MD, PhD

Role: primary

anna.santesson@regionhalland.se

Anna Ohlis, MD, PhD

Role: primary

anna.ohlis@ki.se

Mia Ramklint, MD, PhD

Role: primary

mia.ramklint@uu.se

Other Identifiers

2024-00196

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAFETYRCT2025

Identifier Type: -

Identifier Source: org_study_id