Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)

NCT05537623 | Completed

• 1 other identifier: SAFETY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide is the leading cause of death in the age span 10-19 years in Sweden. The most robust predictor of future suicide attempt and suicide death is prior suicide attempt. Yet, most youths presenting with suicidal behavior to the Child and Adolescent Mental Health Services (CAMHS) in Stockholm, Sweden are not offered evidence-based care directly targeting suicide risk. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable suicide prevention program designed to fill this critical gap. SAFETY is a cognitive behavioral family treatment incorporating elements from Dialectical Behavior Therapy and Multisystemic Therapy. SAFETY has shown promise in reducing suicide attempts in two small-N trials. In a randomized controlled feasibility trial, the investigators will examine the feasibility of SAFETY and an active control condition named Supportive Therapy at post-treatment, 3 and 12 months after treatment on youth suicidal behavior. Evaluations of feasibility, acceptability, and safety based on data from this pilot trial will guide and inform the design of a full-scale randomized controlled trial.

Conditions

Suicide and Self-harm

Outcome Measures

Primary Outcomes (13)

• Number of completed assessments at week 12

  Defined as number of completed assessments at end of intervention (week 12)

  week 12

• Number of completed assessments at 3 months follow-up

  Defined as number of completed assessments 3 months after end of intervention

  3 months follow-up

• Number of completed assessments at 12 months follow-up

  Defined as number of completed assessments 12 months after end of intervention

  12 months follow-up

• The fraction of eligible participants who consent to inclusion and randomization

  The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.

  week 12

• Compliance

  Compliance will be defined as number of completed sessions.

  week 12

• Credibility/Expectancy Scale (CEQ)

  The CEQ is a 6-item measure of treatment credibility and expectancy. Scale points ranges from 0-9 and 0-100%, where a higher score indicates a better outcome.

  week 1 (youth and parent reported)

• Client Satisfaction Questionnaire (CSQ)

  The CSQ-8 is an 8-item self-rated 4-point scale, measuring different aspects of satisfaction with treatment, e.g. perception of quality of treatment, if the treatment adequately addressed their needs and overall satisfaction. Total range is 8 to 32, with higher values indicating higher satisfaction. Mean in total satisfaction scores on the CSQ-8 for each treatment group at end of treatment will be reported.

  week 12 (youth and parent reported)

• Adverse events

  Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.

  week 12 (youth and parent reported)

• Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome

  The C-SSRS is a 22-item measure assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm. The C-SSRS will be administered as a clinical interview at baseline (week 0).

  week 0 (clinician reported)

• Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome

  See description above (outcome 9). The C-SSRS will be administered as a self-rated measure for weekly assessments during treatment.

  once every week during treatment (week 1-11 after baseline; youth reported)

• Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome

  See description above (outcome 9), The C-SSRS will be administered as a clinical interview.

  week 12 (end of treatment; clinician reported)

• Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome

  See description above (outcome 9), The C-SSRS will be administered as a clinical interview.

  3 months after end of treatment (clinician reported)

• Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome

  See description above (outcome 9), The C-SSRS will be administered as a clinical interview.

  12 months after end of treatment (clinician reported)

Secondary Outcomes (24)

• Difficulties In Emotion Regulation Scale (DERS)

  Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)

• Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)

  Change from baseline, once every week during treatment (week 1-11; youth reported)

• Cognitive Emotion Regulation Questionnaire (CERQ)

  Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)

• Behavioral Emotion Regulation Questionnaire (BERQ)

  Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)

• Emotion Beliefs Questionnaire (EBQ)

  Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)

Study Arms (2)

Safe Alternatives for Teens and Youths (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 Youths (SAFETY)

Supportive Therapy

ACTIVE COMPARATOR

Supportive Therapy is a manualized client-centered therapy. The Supportive Therapy will be adapted to match SAFETY to control for nonspecific treatment factors such as therapist characteristics, time, and treatment exposure. The Supportive Therapy program consists of twelve weekly individual sessions with the youth, focusing on the therapeutic supporting relationship between the therapist and the youth, and follow-ups with parents. Therapeutic strategies include acceptance and validation, to increase feelings of connectedness and belonging and counteract thwarted belongingness, helplessness, and hopelessness. Cognitive-behavioral techniques (e.g., active modeling, problem-solving training, cognitive restructuring) are not allowed.

Behavioral: Supportive Therapy

Interventions

Safe Alternatives for Teens and Youths (SAFETY) BEHAVIORAL

Please see description of experimental arm (arm one)

Safe Alternatives for Teens and Youths (SAFETY)

Supportive Therapy BEHAVIORAL

Please see description of active comparator arm (arm two)

Supportive Therapy

Eligibility Criteria

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

You may qualify if:

• Suicidal behavior (defined as suicide attempt, interrupted suicide attempt, aborted suicide attempt, or preparatory behavior) in the last 3 months
• Age 10-17 years
• At least one primary caregiver willing to participate in treatment

You may not qualify if:

• Symptoms requiring other immediate treatment (e.g. psychosis, severe anorexia nervosa)
• Ongoing treatment with DBT
• Individual or life circumstances that could complicate or make treatment participation impossible, or that require immediate intervention (e.g., violence in close relationships; intellectual disability)
• Insufficient understanding of the Swedish language

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Stockholm Regional Council

Stockholm, Stockholm County, 12177, Sweden

Location

Related Publications (1)

• Karemyr M, Bellander M, Ponten M, Ohlis A, Flygare O, Wallden Y, Kuja-Halkola R, Hadlaczky G, Mataix-Cols D, Asarnow JR, Hellner C, Hughes JL, Bjureberg J. Preventing suicide with Safe Alternatives for Teens and Youths (SAFETY): a randomised feasibility trial. BMJ Ment Health. 2025 Apr 29;28(1):e301575. doi: 10.1136/bmjment-2025-301575.

  PMID: 40306939 DERIVED

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior

Interventions

Safety; Palliative Care

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Johan Bjureberg, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: September 13, 2022
• Study Start: December 2, 2022
• Primary Completion: May 13, 2024
• Study Completion: February 13, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)