Clinical trial NCT06931639: Suicide Preventive Psychosocial Treatment for Youths
Official title: Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Attempt
Suicidal and Self-injurious Behavior
Suicide Attempted
Suicide, Attempted
Keywords: Safe Alternatives for Teens and Youths
Self-injurious Behavior
Suicide Attempt
Suicidal Behavior
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 282
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind parallel-group randomized controlled multisite trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Suicide Attempt Score of the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Secondary outcomes:
measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y).
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Work and Social Adjustment Scale, youth version (WSAS-Y)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Children's global assessment scale (CGAS)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Beck's Hopelessness Scale (BHS)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Child Health Utility 9D (CHU-9D)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Recovering Quality of Life (ReQoL)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
Other outcomes:
measure: Self-harm
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Borderline Personality Feature Scale for Children-11 (BPFS-C-11)
timeFrame: Pre-treatment
measure: Levels of Personality Functioning Questionnaire 12-18 (LoPF-Q 12-18)
timeFrame: Pre-treatment
measure: Borderline Symptom List Supplement (BSL-Supplement)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Two weeks after treatment initiation.
measure: Adverse events
timeFrame: Immediately post-treatment
measure: Credibility/Expectancy Questionnaire, short (CEQ)
timeFrame: Pre-treatment
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Immediately post-treatment
measure: Difficulties in Emotion Regulation Scale, Short form (DERS-16)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
measure: Cognitive Emotion Regulation Questionnaire (CERQ, Self-blame sub-scale)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
measure: Behavioral Emotion Regulation Questionnaire (BERQ, Seeking Social Support and Actively Approaching sub-scales)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
measure: Family Assessment Device (FAD, General Functioning sub-scale)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment
measure: Hierarchical Personality Inventory for Children-30 (HiPIC-C-30, Neuroticism and Conscientiousness subscales)
timeFrame: Pre-treatment
measure: Child Trauma Screen (CTS)
timeFrame: Pre-treatment
measure: Functioning
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: School Success Profile (SSP, Parental Encouragement sub-scale)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Coping with Children's Negative Emotions Scale Adolescent version(CCNES-A)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Parenting Distress Index - Short (PDI-Short)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Parental Abuse Scale (PAS)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Register-based outcomes
timeFrame: 24- and 60-month post-treatment
measure: Parent Self-Efficacy for Suicide Scale
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-months post-treatment.
Locations:
city: Helsingborg
country: Sweden
facility: Child and Adolescent Mental Health Services, Region Skåne
city: Karlstad
country: Sweden
facility: Child and Adolescent Psychiatry, Region Värmland
city: Kungsbacka
country: Sweden
facility: Child and Adolescent Mental Health Services, Region Halland
city: Stockholm
country: Sweden
facility: Child and Adolescent Mental Health Services, Region Stockholm
city: Uppsala
country: Sweden
facility: Child and Adolescent Psychiatry, Region Uppsala
Study officials:
References: