Suicide Preventive Psychosocial Treatment for Youths

NCT06931639 | Recruiting DMC

• 2 other identifiers: SAFETYRCT20252024-00196
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Safe Alternatives for Teens and Youths; Self-injurious Behavior; Suicide Attempt; Suicidal Behavior

Outcome Measures

Primary Outcomes (1)

• Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records

  Any report of suicide attempt, using data collected from: 1. Youth-report of the C-SSRS. The C-SSRS is a 22-item structured clinical interview assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. 2. Caregiver-report of the C-SSRS (reduced 4-item version including only the suicidal behavior section). 3. Electronic medical records.

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

Secondary Outcomes (8)

• Nonsuicidal self-injury - any report from The Deliberate Self Harm Inventory - Youth version (DSHI-Y)

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

• Work and Social Adjustment Scale, youth version (WSAS-Y)

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

• Children's global assessment scale (CGAS)

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

• Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25)

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

• Beck's Hopelessness Scale (BHS)

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

Other Outcomes (23)

• Self-harm

  Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

• Borderline Personality Feature Scale for Children-11 (BPFS-C-11)

  Pre-treatment

• Levels of Personality Functioning Questionnaire 12-18 (LoPF-Q 12-18)

  Pre-treatment

Study Arms (2)

Safe Alternatives for Teens and Youth (SAFETY)

EXPERIMENTAL

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.

Behavioral: Safe Alternatives for Teens and Youth (SAFETY)

Enhanced Treatment As Usual

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Treatment As Usual

Interventions

Enhanced Treatment As Usual BEHAVIORAL

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

Enhanced Treatment As Usual

Safe Alternatives for Teens and Youth (SAFETY) BEHAVIORAL

Please see description of experimental arm (arm one)

Safe Alternatives for Teens and Youth (SAFETY)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Symptoms obstructing participation in assessments or treatment
• Insufficient understanding of the Swedish language in youth and/or caregiver
• Enrolled in Dialectical Behavioral Therapy

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (5)

Child and Adolescent Mental Health Services, Region Skåne

Helsingborg, 25225, Sweden

RECRUITING

Child and Adolescent Psychiatry, Region Värmland

Karlstad, Sweden

NOT YET RECRUITING

Child and Adolescent Mental Health Services, Region Halland

Kungsbacka, 301 85, Sweden

RECRUITING

Child and Adolescent Mental Health Services, Region Stockholm

Stockholm, 118 51, Sweden

RECRUITING

Child and Adolescent Psychiatry, Region Uppsala

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Self-Injurious Behavior

Interventions

Safety

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Central Study Contacts

Lydia Peraza Aguiar, MSc

CONTACT

+46735170963; lydia.peraza.aguiar@ki.se

Moa Karemyr, MSc

CONTACT

+46723950443; moa.karemyr@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be informed that they will be allocated to one of two psychosocial interventions addressing suicidality. Participants cannot be completely blinded; however, information about the two interventions will be kept to a minimum in the informed consent to avoid nocebo. Therapists who recruit participants and outcomes assessors will be blinded to the randomization sequence, and outcomes assessors will also be blinded to time-point. All participants will receive instructions not to reveal their treatment condition to the outcomes assessor. To assess the integrity of the blinded ratings, the blinded assessors will be instructed to record if the family accidentally revealed the condition, guess the participant's treatment allocation and motivation for their guess. If an assessor becomes unblinded, subsequent assessments for that participant will be conducted by a different assessor. Blinding will be broken after FU3 but masked assessors will remain blinded through follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-blind parallel-group randomized controlled multisite trial

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 17, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2032
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)