Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06931639

Suicide Preventive Psychosocial Treatment for Youths

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child and Adolescent Mental Health Services, Region Skåne, Helsingborg, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusions criteria:

  • Suicide attempt in the last 3 months
  • Age 10-17 years
  • At least one primary caregiver (multiple is allowed) willing to participate in treatment

Exclusion criteria

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

Treatment and study plan

Safe Alternatives for Teens and Youth (SAFETY)

Behavioral

Please see description of experimental arm (arm one)

Enhanced Treatment as Usual

Behavioral

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

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

  3. Children's global assessment scale (CGAS)

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

    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.

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

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

    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.

  5. Beck's Hopelessness Scale (BHS)

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

    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.

  6. Child Health Utility 9D (CHU-9D)

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

    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.

  7. Recovering Quality of Life (ReQoL)

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

    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.

  8. Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)

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

    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.

Other outcomes

  1. Self-harm

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

    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.

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

    Time frame: Pre-treatment

    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.

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

    Time frame: Pre-treatment

    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.

  4. Borderline Symptom List Supplement (BSL-Supplement)

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

    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.

  5. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Immediately post inclusion assessment and crisis planning intervention.

    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.

  6. Adverse events

    Time frame: Immediately post-treatment

    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.

  7. Credibility/Expectancy Questionnaire, short (CEQ)

    Time frame: Pre-treatment

    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.

  8. Client Satisfaction Questionnaire (CSQ)

    Time frame: Immediately post-treatment

    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.

  9. Difficulties in Emotion Regulation Scale, Short form (DERS-16)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment

    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.

  10. Cognitive Emotion Regulation Questionnaire (CERQ, Self-blame sub-scale)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment

    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.

  11. Behavioral Emotion Regulation Questionnaire (BERQ, Seeking Social Support and Actively Approaching sub-scales)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment

    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.

  12. Interpersonal Needs Questionnaire (INQ)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment

    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.

  13. Family Assessment Device (FAD, General Functioning sub-scale)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment

    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.

  14. Hierarchical Personality Inventory for Children-30 (HiPIC-C-30, Neuroticism and Conscientiousness subscales)

    Time frame: Pre-treatment

    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.

  15. Child Trauma Screen (CTS)

    Time frame: Pre-treatment

    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.

  16. Functioning

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

    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.

  17. School Success Profile (SSP, Parental Encouragement sub-scale)

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

    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.

  18. Coping with Children's Negative Emotions Scale Adolescent version(CCNES-A)

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

    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.

  19. Parenting Distress Index - Short (PDI-Short)

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

    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.

  20. Parental Abuse Scale (PAS)

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

    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.

  21. Register-based outcomes

    Time frame: 24- and 60-month post-treatment

    Data on psychiatric disorders, clinical care consumption, pharmacological prescriptions, employment status, and academic performance will be derived from national population-based registers.

  22. Parent Self-Efficacy for Suicide Scale

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

    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.

  23. Patient Health Questionnaire (PHQ-9)

    Time frame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-months post-treatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lydia Peraza Aguiar, MSc

CONTACT

[email protected]

+46735170963

Moa Karemyr, MSc

CONTACT

[email protected]

+46723950443

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.