Suicide Preventive Psychosocial Treatment for Youths
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Safe Alternatives for Teens and Youth (SAFETY), Enhanced Treatment As Usual.
- Кому может быть актуально
- Состояния в реестре: Suicide Attempt, Suicidal and Self-injurious Behavior, Suicide Attempted, Suicide, Attempted. Базовые параметры: 10 лет — 17 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Safe Alternatives for Teens and Youth (SAFETY)
Please see description of experimental arm (arm one) - Поведенческое Enhanced Treatment As Usual
Please see description of active comparator arm (arm two).
Первичные конечные точки
- Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
Вторичные конечные точки (8)
- Nonsuicidal self-injury - any report from The Deliberate Self Harm Inventory - Youth version (DSHI-Y) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Work and Social Adjustment Scale, youth version (WSAS-Y) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Children's global assessment scale (CGAS) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Revised Children's Anxiety and Depression Scale, 25 item version (RCADS-25) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Beck's Hopelessness Scale (BHS) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Child Health Utility 9D (CHU-9D) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Recovering Quality of Life (ReQoL) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TIC-P) [Срок оценки: Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.]
Критерии участия
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
Критерии исключения
- Symptoms obstructing participation in assessments or treatment
- Insufficient understanding of the Swedish language in youth and/or caregiver
- Enrolled in Dialectical Behavioral Therapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Швеция · 5 центров
- Child and Adolescent Mental Health Services, Region Skåne — Helsingborg
- Child and Adolescent Psychiatry, Region Värmland — Karlstad
- Child and Adolescent Mental Health Services, Region Halland — Kungsbacka
- Child and Adolescent Mental Health Services, Region Stockholm — Stockholm
- Child and Adolescent Psychiatry, Region Uppsala — Uppsala
Идентификаторы
NCT: NCT06931639 · SAFETYRCT2025 · 2024-00196