Suicide Preventive Psychosocial Treatment for Youths: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 5
- 主要终点
- Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
- To establish the 12-month durability of the treatment effects.
- 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).
- 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.
- Test whether emotion regulation, thwarted belongingness and perceived burdensomeness, parental invalidation, and family functioning mediate treatment outcome.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Symptoms obstructing participation in assessments or treatment
- •Insufficient understanding of the Swedish language in youth and/or caregiver
- •Enrolled in Dialectical Behavioral Therapy
研究组 & 干预措施
Safe Alternatives for Teens and Youth (SAFETY)
SAFETY is a transdiagnostic cognitive-behavioral family treatment informed by Dialectical Behavior Therapy (DBT) and Multisystemic Therapy (MST). The twelve week long treatment is principle based, structured in phases, and individually tailored based on a cognitive-behavioral fit analysis that specifies key risk and protective processes. Each session contains one individual component for youth and parents respectively, and one family component where youth and parents work together with therapists to practice skills identified as critical for preventing future suicidal behavior. Treatment targets are arranged in a SAFETY Pyramid, consisting of (a) safe settings; (b) safe people; (c) safe activities and actions; (d) safe thought; and (e) safe stress reactions, emphasizing strengthening protective support and validation within the family and/or social environment surrounding the youth.
干预措施: Safe Alternatives for Teens and Youth (SAFETY) (Behavioral)
Enhanced Treatment As Usual
Enhanced Treatment As Usual (ETAU) consists of treatment as usual delivered by community clinicians enhanced by the evidence-informed Stanley-Brown Safety Planning Intervention, adapted for adolescents (e.g. involving both youth and parents) and to a Swedish context by the Swedish Association for Child and Adolescent Psychiatry and supervised by the research group. The adapted Safety Planning intervention include an assessment of current and future risk and protective factors for suicide, current and future suicide risk, and an individualized safety plan. We will ensure that the control intervention Safety Planning is delivered in a safe and comparable way across regions. Patients in both conditions will have access to standard care (including pharmaceutical treatment), as well as inpatient care as deemed necessary. The level of standard care will be carefully measured throughout the trial and included in statistical sensitivity analyses.
干预措施: Enhanced Treatment As Usual (Behavioral)
结局指标
主要结局
Suicide Attempt - any report from the Columbia-Suicide Severity Rating Scale (C-SSRS) or electronic medical records
时间窗: 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.
次要结局
- 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.)
- Beck's Hopelessness Scale (BHS)(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)(Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.)
- Children's global assessment scale (CGAS)(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)(Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.)
- Child Health Utility 9D (CHU-9D)(Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.)
- Recovering Quality of Life (ReQoL)(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)(Pre-treatment, immediately post-treatment, as well as 3-, 12-, 24- and 60-month post-treatment.)
研究者
Johan Bjureberg
Associate Professor
Karolinska Institutet