Clinical trial NCT05537623: Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY)
Official title: Preventing Suicide With Safe Alternatives for Teens and Youths (SAFETY) - A Randomized Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide and Self-harm
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2022-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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:

1. 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?
2. 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?
3. Is the planned procedure and design (recruitment, blinded assessors, randomization and data attrition) of the study feasible?
4. What are the proportions of suicidal behavior in the group randomized to SAFETY group and the group randomized to Supportive Therapy, respectively?
5. 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)?
6. 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)?
7. How do the youths and caregivers experience participation in SAFETY and Supportive Therapy, respectively?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of completed assessments at week 12
timeFrame: week 12
measure: Number of completed assessments at 3 months follow-up
timeFrame: 3 months follow-up
measure: Number of completed assessments at 12 months follow-up
timeFrame: 12 months follow-up
measure: The fraction of eligible participants who consent to inclusion and randomization
timeFrame: week 12
measure: Compliance
timeFrame: week 12
measure: Credibility/Expectancy Scale (CEQ)
timeFrame: week 1 (youth and parent reported)
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: week 12 (youth and parent reported)
measure: Adverse events
timeFrame: week 12 (youth and parent reported)
measure: Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
timeFrame: week 0 (clinician reported)
measure: Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
timeFrame: once every week during treatment (week 1-11 after baseline; youth reported)
measure: Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
timeFrame: week 12 (end of treatment; clinician reported)
measure: Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
timeFrame: 3 months after end of treatment (clinician reported)
measure: Columbia Suicide Severity Rating Scale (C-SSRS) as exploratory clinical outcome
timeFrame: 12 months after end of treatment (clinician reported)
Secondary outcomes:
measure: Difficulties In Emotion Regulation Scale (DERS)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
measure: Brief 16-item Version of the Difficulties In Emotion Regulation Scale (DERS-16)
timeFrame: Change from baseline, once every week during treatment (week 1-11; youth reported)
measure: Cognitive Emotion Regulation Questionnaire (CERQ)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Behavioral Emotion Regulation Questionnaire (BERQ)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Emotion Beliefs Questionnaire (EBQ)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Perth Alexithymia Questionnaire (PAQ)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 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)
measure: Systemic Clinical Outcome and Routine Evaluation, 15 item version (SCORE-15)
timeFrame: 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)
measure: Deliberate Self-Harm Inventory - Youth version (DSHI-Y)
timeFrame: 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)
measure: Revised Children's Anxiety and Depression Scale, short (RCADS-S)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Beck's Hopelessness Scale (BHS)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
measure: 1-item version of the Perceived Criticism Measure (PCM - 1 item version)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Borderline Symptom List Supplement (BSL-Supplement)
timeFrame: 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)
measure: Dialectical Behavior Therapy - Ways of Coping Checklist (DBT-WCCL)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: CRAFFT
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: The Coping with Children's Negative Emotions Scale - Adolescent Version (CCNES-A)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
measure: Generalized anxiety disorder 7-item scale (GAD-7)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
measure: The Work and Social Adjustment Scale, youth version (WSAS-Y) - adolescent and parent versions
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth and parent reported)
measure: Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (parent reported)
measure: Child Health Utility 9D (CHU-9D)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (youth reported)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
measure: The Clinical Global Impressions -Severity and Improvement scales (CGI-S; CGI-I)
timeFrame: Change from baseline, week 12 (end of treatment), 3 months and 12 months after end of treatment (clinician reported)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Regional Council
Study officials:
affiliation: Karolinska Institutet
name: Johan Bjureberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: