Suicide and Self-harmSAFETYF2022NCT05537623
Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)
A study testing Safe Alternatives for Teens and Youths (SAFETY) and Supportive Therapy in people with Suicide and Self-harm, run by Region Stockholm at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- Safe Alternatives for Teens and Youths (SAFETY) and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 2 Dec 2022to 13 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
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.
Read the detailed description
Research questions:
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS?
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS?
- Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible?
- What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively?
- Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)?
- Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)?
- How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?
- Conditions
- Suicide and Self-harm
- Being tested
- Safe Alternatives for Teens and Youths (SAFETY), Supportive Therapy
- Medical subject headings
- Suicide, 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 Youths (SAFETY)Behavioural
Please see description of experimental arm (arm one)
Supportive TherapyBehavioural
Please see description of active comparator arm (arm two)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of completed assessments at week 12
Defined as number of completed assessments at end of intervention (week 12)
Measured: week 12
Number of completed assessments at 3 months follow-up
Defined as number of completed assessments 3 months after end of intervention
Measured: 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
Measured: 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.
Measured: week 12
Compliance
Compliance will be defined as number of completed sessions.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after end of treatment (clinician reported)
Secondary outcomes (24)
Difficulties In Emotion Regulation Scale (DERS)
The DERS is a measure of difficulties in emotion regulation, with 36 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Measured: 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)
DERS-16 is a brief 16-item version of the DERS, see description above, with 16 items rated on a 1-5 Likert scale, with a higher score indicating greater difficulties with emotion regulation.
Measured: Change from baseline, once every week during treatment (week 1-11; youth reported)
Cognitive Emotion Regulation Questionnaire (CERQ)
The CERQ is a measure of cognitive emotion regulation, with 36 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with cognitive emotion regulation.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Behavioral Emotion Regulation Questionnaire (BERQ)
The BERQ is a measure of behavioral emotion regulation, with 20 items on a Likert scale ranging from 1-5. A higher score indicates greater difficulties with behavioral emotion regulation.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Emotion Beliefs Questionnaire (EBQ)
The EBQ is a measure of emotion beliefs, with 16 items on a Likert scale ranging from 1-7. A higher score indicates more maladaptive beliefs about emotions.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Perth Alexithymia Questionnaire (PAQ)
The PAQ is a measure of how emotions are perceived and experienced, with 24 items on a Likert scale ranging from 1-7. A higher score indicates greater difficulties related to alexithymia.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a measure of perceived social support, with 12 items on a Likert scale ranging from 1-7. A higher score indicates higher level of perceived social support.
Measured: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)
The SCORE-15 is a measure of family function, with 15 items on a Likert scale ranging from 1-5. A higher score indicates greater family function.
Measured: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Deliberate Self-Harm Inventory - Youth version (DSHI-Y)
The DSHI-Y is a 7-item measure assessing occurrence, method, frequency of deliberate self-harm. A higher score indicates higher frequency and severity of self-harm. The DSHI-Y will be administered as a clinical interview at baseline, post and follow-up, and as a self-rated measure for weekly assessments.
Measured: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Revised Children's Anxiety and Depression Scale, short (RCADS-S)
The RCADS-S, a shortened version of the Spence Child Anxiety Scale, is a child self-report measure of anxiety- and depression-related psychopathology. Total range is 0-45, Likert scale ranging from 0-3, with higher values representing a worse outcome.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Beck's Hopelessness Scale (BHS)
The BHS is a measure of hopelessness, with 20 dichotomous "true/false" items. A higher score indicates greater difficulties related to hopelessness.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
1-item version of the Perceived Criticism Measure (PCM - 1 item version)
The PCM - 1 item version is a measure of expressed emotion, consisting of one question on a Likert scale ranging from 0-10, about how critical an emotionally important individual is perceived to be by the rater.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Borderline Symptom List Supplement (BSL-Supplement)
The BSL-Supplement is a 11-item measure of self-destructive behaviors. Higher score indicates higher frequency of self-destructive behaviors.
Measured: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)
The DBT-WCCL is a measure of use of DBT skills use and dysfunctional ways of coping with emotions. Higher average score in the skills use subscale and lower average scores in the dysfunctional coping subscales indicate greater functional coping.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
CRAFFT
CRAFFT is a 9-item screening measure of alcohol and substance use. A higher score indicates greater difficulties related to substance use.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 18-item measure of sleep problems. A higher score indicates greater sleep problems.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)
The CCNES-A is a measure of parental coping responses in response to adolescents' negative emotions. The CCNES-A version used in this trial consists of nine hypothetical scenarios accompanied by six types of responses, rated on a Likert scale ranging from 1-7.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a measure of depression, with 10 items on a Likert scale ranging from 0-3. Higher score indicates greater depressive symptoms.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Generalized anxiety disorder 7-item scale (GAD-7)
The GAD-7 is a measure of anxiety, with 7 items on a Likert scale ranging from 0-3. Higher score indicates greater anxiety symptoms.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions
WSAS-Y is a measure 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: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
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. In the present trial no health economic evaluations will be conducted. Rather this instrument is included to gain feasibility data in preparation of a planned larger randomized controlled trial. Therefore, no data on TiC-P will be reported in this trial.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Child Health Utility 9D (CHU-9D)
The CHU-9D is a measure of health related quality of life, with 9 items on a Likert scale ranging from 1-5. A higher score indicates greater health-related quality of life.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Children's Global Assessment Scale (CGAS)
The CGAS is a single item clinician rated 1-100 scale that integrates psychological, social, and academic functioning in children as a measure of psychiatric disturbance. Higher values represent a better outcome.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)
The CGI-S and CGI-I are clinician rated 1-item scales ranging from 1-7 where higher ratings indicate greater symptom severity (CGI-S), and greater symptom improvement (CGI-I), respectively.
Measured: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start2 Dec 2022
- Primary completion13 May 2024
- Study completion13 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Johan Bjureberg, Region Stockholm
- Investigators
- Johan Bjureberg, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537623
- Sponsor's protocol ID
- SAFETY
- Acronym
- SAFETYF2022
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40306939
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05537623
- Acronym / sponsor ID
- SAFETYF2022 / SAFETY
- Conditions
- Suicide and Self-harm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research questions:
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer SAFETY to youths with suicidal behavior and their caregivers within the CAMHS?
- Is it feasible (operationalized as participation in treatment, completed homework assignments, reported adverse events) to offer Supportive Therapy as an active control treatment to youths with suicidal behavior and their caregivers within the CAMHS?
- Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible?
- What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively?
- Is participation in SAFETY and Supportive Therapy associated with improved emotion regulation, perceived social support, and family function, and how large are the effects (suggested treatment processes)?
- Is participation in SAFETY and Supportive Therapy associated with improvements in nonsuicidal self-injury, depression, anxiety, and other outcomes, and how large are the effects (outcomes)?
- How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe Alternatives for Teens and Youths (SAFETY) | Experimental | Behavioral: Safe Alternatives for Teens and Youths (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. |
| Supportive Therapy | Active comparator | Behavioral: Supportive TherapySupportive 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe Alternatives for Teens and Youths (SAFETY)Please see description of experimental arm (arm one) | Behavioural | Safe Alternatives for Teens and Youths (SAFETY) |
| Supportive TherapyPlease see description of active comparator arm (arm two) | Behavioural | Supportive Therapy |
Primary outcome
Number of completed assessments at week 12
Time frame: week 12
Defined as number of completed assessments at end of intervention (week 12)
Number of completed assessments at 3 months follow-up
Time frame: 3 months follow-up
Defined as number of completed assessments 3 months after end of intervention
Number of completed assessments at 12 months follow-up
Time frame: 12 months follow-up
Defined as number of completed assessments 12 months after end of intervention
The fraction of eligible participants who consent to inclusion and randomization
Time frame: week 12
The fraction of potential participants will be determined as the number of eligible persons compared to the number of randomized persons.
Compliance
Time frame: week 12
Compliance will be defined as number of completed sessions.
Credibility/Expectancy Scale (CEQ)
Time frame: week 1 (youth and parent reported)
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.
Client Satisfaction Questionnaire (CSQ)
Time frame: week 12 (youth and parent reported)
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.
Adverse events
Time frame: week 12 (youth and parent reported)
Participants are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Time frame: week 0 (clinician reported)
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).
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Time frame: once every week during treatment (week 1-11 after baseline; youth reported)
See description above (outcome 9). The C-SSRS will be administered as a self-rated measure for weekly assessments during treatment.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Time frame: week 12 (end of treatment; clinician reported)
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Time frame: 3 months after end of treatment (clinician reported)
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
Time frame: 12 months after end of treatment (clinician reported)
See description above (outcome 9), The C-SSRS will be administered as a clinical interview.
24 secondary outcomes
Difficulties In Emotion Regulation Scale (DERS)
Time frame: 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)
Time frame: Change from baseline, once every week during treatment (week 1-11; youth reported)
Cognitive Emotion Regulation Questionnaire (CERQ)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Behavioral Emotion Regulation Questionnaire (BERQ)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Emotion Beliefs Questionnaire (EBQ)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Perth Alexithymia Questionnaire (PAQ)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)
Time frame: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Deliberate Self-Harm Inventory - Youth version (DSHI-Y)
Time frame: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Revised Children's Anxiety and Depression Scale, short (RCADS-S)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Beck's Hopelessness Scale (BHS)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
1-item version of the Perceived Criticism Measure (PCM - 1 item version)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Borderline Symptom List Supplement (BSL-Supplement)
Time frame: Change from baseline, once every week during treatment (week 1-11), week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
CRAFFT
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Generalized anxiety disorder 7-item scale (GAD-7)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
Child Health Utility 9D (CHU-9D)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
Children's Global Assessment Scale (CGAS)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)
Time frame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 40306939Karemyr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Bjureberg, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe Alternatives for Teens and Youths (SAFETY) and Supportive Therapy in people with Suicide and Self-harm, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of completed assessments at week 12 (time frame: week 12). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05537623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.