Suicidal and Self-injurious Behavior, Suicide Attempt, Suicide Attempted, Suicide, Attempted
Conditions
Keywords
Safe Alternatives for Teens and Youths, Self-injurious Behavior, Suicide Attempt, Suicidal Behavior
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 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.
Interventions
BEHAVIORALSafe Alternatives for Teens and Youth (SAFETY)
Please see description of experimental arm (arm one)
BEHAVIORALEnhanced Treatment As Usual
Please see description of active comparator arm (arm two).
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be informed that they will be allocated to one of two psychosocial interventions addressing suicidality. Participants cannot be completely blinded; however, information about the two interventions will be kept to a minimum in the informed consent to avoid nocebo. Therapists who recruit participants and outcomes assessors will be blinded to the randomization sequence, and outcomes assessors will also be blinded to time-point. All participants will receive instructions not to reveal their treatment condition to the outcomes assessor. To assess the integrity of the blinded ratings, the blinded assessors will be instructed to record if the family accidentally revealed the condition, guess the participant's treatment allocation and motivation for their guess. If an assessor becomes unblinded, subsequent assessments for that participant will be conducted by a different assessor. Blinding will be broken after FU3 but masked assessors will remain blinded through follow-up.
Intervention model description
Single-blind parallel-group randomized controlled multisite trial
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records | 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: 1. 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. 2. Caregiver-report of the C-SSRS (reduced 4-item version including only the suicidal behavior section). 3. Electronic medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonsuicidal self-injury - any report from The 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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. Rated by parents. |
Countries
Sweden
Contacts
CONTACTLydia Peraza Aguiar, MSc
CONTACTMoa Karemyr, MSc
Outcome results
None listed