Suicide AttemptNCT06931639
Suicide Preventive Psychosocial Treatment for Youths
A study testing Safe Alternatives for Teens and Youth (SAFETY) and Enhanced Treatment As Usual in people with Suicide Attempt and Suicidal and Self-injurious Behavior, run by Karolinska Institutet at 5 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Suicide Attempt, Suicidal and Self-injurious Behavior, Suicide Attempted
- What is being tested?
- Safe Alternatives for Teens and Youth (SAFETY) and Enhanced Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 5 sitesSweden
- Study dates
- 28 May 2025to Sep 2032
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Symptoms obstructing participation in assessments or treatment
- Insufficient understanding of the Swedish language in youth and/or caregiver
- Enrolled in Dialectical Behavioral Therapy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Child and Adolescent Mental Health Services, Region Skåne
Helsingborg, 25225
Eva Serlachius, MD, PhD, eva.serlachius@med.lu.se
Eva Serlachius, MD, PhD
- Recruiting
Child and Adolescent Mental Health Services, Region Halland
Kungsbacka, 301 85
Anna Santesson, MD, PhD, anna.santesson@regionhalland.se
Anna Santesson, MD, PhD
- Not yet recruiting
Child and Adolescent Psychiatry, Region Östergötland
Linköping
Maria Zetterqvist, lic. Psychologist, Ph.D., maria.zetterqvist@liu.se
Maria Zetterqvist, lic. Psychologist, Ph.D.
- Recruiting
Child and Adolescent Mental Health Services, Region Stockholm
Stockholm, 118 51
Anna Ohlis, MD, PhD, anna.ohlis@ki.se
Anna Ohlis, MD, PhD
- Recruiting
Child and Adolescent Psychiatry, Region Uppsala
Uppsala
Mia Ramklint, MD, PhD, mia.ramklint@uu.se
Mia Ramklint, MD, PhD
About this study
Official title: Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
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.
Read the 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 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
- 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.
- 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.
- To establish the 12-month durability of the treatment effects.
- 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).
- 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.
- Test whether emotion regulation, thwarted belongingness and perceived burdensomeness, parental invalidation, and family functioning mediate treatment outcome.
- 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
- Being tested
- Safe Alternatives for Teens and Youth (SAFETY), Enhanced Treatment As Usual
- Keywords
- Safe Alternatives for Teens and Youths, Self-injurious Behavior, Suicide Attempt, Suicidal Behavior
- Medical subject headings
- Suicide, Attempted, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe Alternatives for Teens and Youth (SAFETY)Behavioural
Please see description of experimental arm (arm one)
Enhanced Treatment As UsualBehavioural
Please see description of active comparator arm (arm two).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with 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:
- 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.
- Caregiver-report of the C-SSRS (reduced 4-item version including only the suicidal behavior section).
- Electronic medical records.
Measured: 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)
The DSHI-Y used in this trial is a 8-item clinican-rated interview that will be used to assess presence and frequency (0 to ∞) of non-suicidal self-injury, where a higher score indicates higher frequency of non-suicidal self-injury. One item measuring non-suicidal intoxications has been added to the original DSHI-Y. The DSHI-Y is adapted for adolescents from the DSHI an empirically supported measure of various aspects of NSSI originally developed for use with adults. The DSHI has demonstrated good test-retest reliability and adequate concurrent validity among adolescents. For youths who decline participation in follow-up interviews, a one-item version of the DSHI-Y assessing presence of any nonsuicidal self-injury will be administered to the youth's caregiver when caregiver report is available.
Measured: 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)
WSAS-Y is a clinician-rated scale of impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. The scale generates a global score ranging from 0 to 40, with higher scores indicating greater impairment.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Children's global assessment scale (CGAS)
The CGAS is a clinician rated single item 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent better functioning.
Measured: 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)
The RCADS-25, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology, with six subscales; separation anxiety, social anxiety, generalized anxiety, panic disorder, obsessive-compulsive disorder and major depressive disorder, as well as a total anxiety-scale. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Beck's Hopelessness Scale (BHS)
Beck's Hopelessness Scale is a youth self-rated measure of hopelessness, with 20 dichotomous "true/false" items measuring hopelessness in three domains; feelings about the future, loss of motivation and expectations. A higher score indicates greater difficulties related to hopelessness.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Child Health Utility 9D (CHU-9D)
The CHU-9D is a youth-rated measure of health related quality of life for youth, with 9 items on a Likert scale ranging from 0-4. Scores range from 0-36, with a lower score indicating greater health-related quality of life.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Recovering Quality of Life (ReQoL)
Recovering Quality of Life is a parent-rated measure of health-related quality of life for adults, with 10 items on a Likert scale of 0-4, yielding a range of 0-40, where a higher score indicate higher quality of life.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
The TIC-P is a 37-item measure assessing healthcare and societal resource use, including for example items on healthcare resource use, medications, school absenteeism, and parental productivity loss. Rated by parents.
Measured: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start28 May 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind parallel-group randomized controlled multisite trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Bjureberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931639
- Sponsor's protocol ID
- SAFETYRCT2025
- Other IDs
- 2024-00196
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient-level data are not publicly available due to national (Swedish) and EU legislation but could be made available from the corresponding author upon reasonable request following approval from the Swedish Ethical Review Authority.