Suicide Preventive Psychosocial Treatment for Youths

Not Applicable

Not yet recruiting

• Conditions: Suicide Attempted; Suicide, Attempted; Suicide Attempt; Suicidal and Self-injurious Behavior

• Registration Number: NCT06931639
• Lead Sponsor: Karolinska Institutet

Brief 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. 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.

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 (as measured by the masked assessor-administered C-SSRS) 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 Timeline

• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-16
• Study First Posted: 2025-04-17
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-09
• Study Completion: 2032-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Suicide Attempt Score of the Columbia Suicide Severity Rating Scale (C-SSRS)	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	The C-SSRS is a 22-item structured clinical interview assessing the frequency and severity of suicidal ideation, suicidal behaviors, and self-harm.

Secondary Outcome Measures

Name	Time	Method
Deliberate Self-Harm Inventory - Youth version (DSHI-Y).	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	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.
Work and Social Adjustment Scale, youth version (WSAS-Y)	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.
Children's global assessment scale (CGAS)	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	The CGAS is a 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.
Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25)	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.
Beck's Hopelessness Scale (BHS)	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	Beck's Hopelessness Scale is a 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.
Child Health Utility 9D (CHU-9D)	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	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.
Recovering Quality of Life (ReQoL)	Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.	Recovering Quality of Life includes 21 questions rated on a Likert scale of 0-4, assessing health related quality of life. Higher scores indicate higher quality of life.
Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)	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.

Trial Locations

Locations (5)

Child and Adolescent Psychiatry, Region Uppsala; 🇸🇪 Uppsala, Sweden

Child and Adolescent Mental Health Services, Region Skåne; 🇸🇪 Helsingborg, Sweden

Child and Adolescent Psychiatry, Region Värmland; 🇸🇪 Karlstad, Sweden

Child and Adolescent Mental Health Services, Region Halland; 🇸🇪 Kungsbacka, Sweden

Child and Adolescent Mental Health Services, Region Stockholm; 🇸🇪 Stockholm, Sweden