Suicide Preventive Psychosocial Treatment for Youths

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide, Attempted; Suicidal and Self-injurious Behavior; Suicide Attempt; Suicide Attempted
• Intervention / Treatment: Behavioral: Safe Alternatives for Teens and Youth (SAFETY); Behavioral: Enhanced Treatment As Usual

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

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.

• Study Type: Interventional
• Enrollment (Estimated): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moa Karemyr, MSc; Phone Number: +46723950443; Email: moa.karemyr@ki.se
• Study Contact Backup: Name: Lydia Peraza Aguiar, MSc; Phone Number: +46735170963; Email: lydia.peraza.aguiar@ki.se

Study Locations

• Sweden
  • Helsingborg, Sweden, 25225
    • Recruiting
    • Child and Adolescent Mental Health Services, Region Skåne
    • Contact: Eva Serlachius, MD, PhD; Email: eva.serlachius@med.lu.se
    • Principal Investigator: Eva Serlachius, MD, PhD
  • Karlstad, Sweden
    • Not yet recruiting
    • Child and Adolescent Psychiatry, Region Värmland
    • Contact: Maria Unenge Hallerbäck, MD, Ph.D.; Email: maria.unenge.hallerback@regionvarmland.se
    • Principal Investigator: Maria Unenge Hallerbäck, MD, Ph.D.
  • Kungsbacka, Sweden, 301 85
    • Recruiting
    • Child and Adolescent Mental Health Services, Region Halland
    • Contact: Anna Santesson, MD, PhD; Email: anna.santesson@regionhalland.se
    • Principal Investigator: Anna Santesson, MD, PhD
  • Stockholm, Sweden, 118 51
    • Recruiting
    • Child and Adolescent Mental Health Services, Region Stockholm
    • Contact: Anna Ohlis, MD, PhD; Email: anna.ohlis@ki.se
    • Principal Investigator: Anna Ohlis, MD, PhD
  • Uppsala, Sweden
    • Recruiting
    • Child and Adolescent Psychiatry, Region Uppsala
    • Contact: Mia Ramklint, MD, PhD; Email: mia.ramklint@uu.se
    • Principal Investigator: Mia Ramklint, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusions 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Safe Alternatives for Teens and Youth (SAFETY); Please see description of experimental arm (arm one)
Active Comparator: 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.	Behavioral: Enhanced Treatment As Usual; Please see description of active comparator arm (arm two).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
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.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Register-based outcomes	Data on psychiatric disorders, clinical care consumption, pharmacological prescriptions, employment status, and academic performance will be derived from national population-based registers.	24- and 60-month post-treatment
Parent Self-Efficacy for Suicide Scale	The Parent Self-Efficacy for Suicide Scale is a parent-rated measure of self-efficacy, or confidence, regarding parents' ability to engage in nine activities to prevent or assist their child in managing a suicidal crisis, and parent expectations of adolescents' risk of subsequent suicide. The measure contains 12 items, rated on a scale of 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident), resulting in a range of 0-120. The measure includes two subscales: self-efficacy (9 items) and expectation (3 items). Higher scores indicate higher levels of self-efficacy, and greater expectations of a positive outcome regarding suicidality.	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)	The BPFS-C-11 is a youth-rated 11-item measure of borderline personality features for children 9 - 18 years old. The BPFS-C-11 includes indicators of borderline pathology such as affective instability, identity problems, and negative relationships. Item responses are on a 5-point Likert scale, yielding a range of 11-55, with higher scores indicating higher levels of borderline features.	Pre-treatment
Levels of Personality Functioning Questionnaire 12-18 (LoPF-Q 12-18)	LoPF-Q 12-18 is a youth-rated 20-item measure rated on a scale of 0-4, yielding a range of 0-80, where a higher score indicates higher impairment in personality functioning. LoPF-Q is developed for use in adolescent populations between 12 and 18 years to assess the dimensions of personality functioning: identity, self-direction, empathy, and intimacy.	Pre-treatment
Borderline Symptom List Supplement (BSL-Supplement)	The BSL-Supplement is a youth-rated 9-item measure of self-destructive behaviors under the past 7 days, with answers ranging from "Not at all" to "Daily or even more often". Higher scores indicate a higher frequency of self-destructive behaviors.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Adverse events	Participants (parents and youths) are asked to report and rate the discomfort of the eventual adverse events caused by their participation in the treatment. Adverse events are also continuously screened for, recorded, and monitored by study personnel.	Immediately post-treatment
Credibility/Expectancy Questionnaire, short (CEQ)	At baseline, we use one item from the CEQ addressing treatment expectancy. Scale points for this item range from 0-100%, where a higher score indicates higher expectancy. This item is both youth and parent-rated.	Pre-treatment
Client Satisfaction Questionnaire (CSQ)	The CSQ is a youth- and parent-rated 8-item measure on a 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. The score ranges from 8-32, where a higher score indicates higher treatment satisfaction.	Immediately post-treatment
Difficulties in Emotion Regulation Scale, Short form (DERS-16)	The DERS-16 is a youth- and parent-rated measure of difficulties in emotion regulation, with 16 items rated on a 1-5 Likert scale, with scores ranging from 16-80 and higher scores indicating greater difficulties in emotion regulation.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
Cognitive Emotion Regulation Questionnaire (CERQ, Self-blame sub-scale)	The CERQ is a youth-rated measure of cognitive emotion regulation. The self-blame sub-scale contains 4 items on a Likert scale ranging from 1-5. Scores range from 4-20, and higher scores indicate greater difficulties with self-blame.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
Behavioral Emotion Regulation Questionnaire (BERQ, Seeking Social Support and Actively Approaching sub-scales)	The BERQ is a youth-rated measure of behavioral emotion regulation. The sub-scales Seeking Social Support and Actively Approaching contains 8 items on a Likert scale ranging from 1-5. Scores range from 8-40. A higher score indicates greater behavioral emotion regulation regarding seeking social support and actively approaching.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
Interpersonal Needs Questionnaire (INQ)	The INQ is a youth-rated measure containing 15 questions rated on a Likert scale of 1-7. The INQ measures beliefs about the extent to which individuals believe their need to belong is met or unmet, as well as the extent to which they perceive themselves to be a burden on the people in their lives. Scores range from 15-105, with higher scores indicating worse outcomes.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
Family Assessment Device (FAD, General Functioning sub-scale)	The FAD is a 60-item questionnaire that measures an individual's perceptions of his/her family, rated by youth and parents. We utilize a subset of 6 questions from the General Functioning Scale of the FAD. Scores range from 0-18, with higher scores indicating greater general family functioning.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
Hierarchical Personality Inventory for Children-30 (HiPIC-C-30, Neuroticism and Conscientiousness subscales)	HiPIC-C-30 is a 30-item measure (Likert scale 1-5) assessing the personality constructs of neuroticism, extraversion, openness, conscientiousness, and agreeableness. We will use the subscales measuring neuroticism and conscientiousness, resulting in a 12-item measure, rated by youths and parents. Scores range from 6-30 within each subscale, and higher scores indicate more neuroticism and conscientiousness, respectively.	Pre-treatment
Child Trauma Screen (CTS)	The CTS is a youth-rated 10-item screening measure of trauma exposure and PTSD symptoms for children ages 6-17. Six questions related to reaction/PTSD symptoms are summed to create a reaction score (rated on a Likert scale of 0-3) yielding a range of 0-18, where a cutoff score of 6 or greater indicates a high likelihood of PTSD diagnosis.	Pre-treatment
Functioning	Three self-composed youth-rated questions measuring school functioning, functioning with peers and family functioning. Each question is rated separately and on a Likert scale from 0-11, with a higher score indicating greater functioning in each respective functioning domain.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
School Success Profile (SSP, Parental Encouragement sub-scale)	Subscales from the SSP will be rated by youths and parents, respectively. Youth will answer 12 questions relating to parental and peer support as well as attitudes toward school. Parents will answer 4 questions relating to parental support. Responses are rated on a 0-4 Likert scale. Higher scores indicate greater support and positive attitudes.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Coping with Children's Negative Emotions Scale Adolescent version(CCNES-A)	The CCNES-A is a measure of parental coping responses in response to youths' negative emotions. The CCNES-A version used in this study consists of nine hypothetical scenarios, accompanied by six theoretically meaningful types of responses (including how well the parent handles their own emotions triggered by the hypothetical situation with the youth) rated by the youth as well as the parent on a Likert scale ranging from 1-7. Higher scores in each subscale representing a response style indicate a higher tendency of the response style.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Parenting Distress Index - Short (PDI-Short)	The PDI-short is parent-rated and includes 2 questions about parenting distress (rated on a Likert scale of 1-5), where higher scores indicate more stress.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Parental Abuse Scale (PAS)	The PAS is youth-rated and contains 7 questions on a Likert scale from 0-4 assessing how often aversive parental behaviors have been experienced by the youth. Scores range from 0-28 and higher scores indicate more frequent experiences of aversive parental behaviors.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Patient Health Questionnaire (PHQ-9)	The PHQ-9 is a parent-rated measure used for screening, diagnosing, monitoring and measuring the severity of depression. The measure contains 9 items, rated on a scale of 0 to 3, resulting in a range of 0-27, where a higher score indicates higher levels of depression.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-months post-treatment.
Credibility/Expectancy Questionnaire (CEQ)	CEQ is a youth and parent-rated 3-item measure of treatment credibility and expectancy. Scale points range from 0-9, and 0-100%, where higher scores indicate greater credibility and expectancy.	Immediately post inclusion assessment and crisis planning intervention.
Self-harm	Composite outcome of suicide attempts (C-SSRS, medical records) and nonsuicidal self-injury (DSHI-Y) ranging from (0 to ∞), in order to enable comparison with other studies.	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Suicidal Behavior; Suicide Attempt; Self-injurious Behavior; Safe Alternatives for Teens and Youths
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Behavior; Self-Injurious Behavior; Suicide, Attempted; Public Health; Environment and Public Health; Accident Prevention; Accidents; Safety
• Other Study ID Numbers: SAFETYRCT2025; 2024-00196 (Other Grant/Funding Number: Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No