PASS (Promote Access to Stop Suicide): A Randomized Controlled Trial Comparing Enhanced Treatment as Usual, Crisis Center Follow up and Wraparound Services for Youth at Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Frequency of repeat suicide attempts in adolescents.
研究概览
简要总结
This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.
详细描述
The proposed project will be able to provide services to high-risk youth in Ohio. This randomized controlled trial for youth discharged from inpatient psychiatric hospital will be able to determine what combination of services is best suited to reduce subsequent suicide attempts and re-hospitalization.
All youth (ages 10-18), that fit the inclusion criteria, will be recruited from the inpatient unit at Fairview Youth Inpatient Unit. Patients will be consented, enrolled, and assigned to group by the Research Coordinator working at the unit. The Methodologist/ Statistician will generate a random allocation sequence using random number generator and communicate group assignment to the Research Coordinator. There will not be any restriction on randomization. The PI will be blinded to all group assignments.
The clinical research tools and screens that will be administered in this study include: Columbia-Suicide Severity Rating Scale (C-SSRS), The Suicidal Ideation Questionnaire (SIQ), The Adverse Childhood Experiences (ACEs), Ohio Scales, Children's Global Assessment Scale (CGAS), Clinical Global Impressions (CGI-I).
The participants of the study will be seen by the child psychiatrist (Dr. Varkula) and the research coordinator at the initial appointment, and a 6 month follow-up (Dr. Falcone). The C-SSRS and the SIQ will be administered at the initial appointment and the follow-up appointment. The study's research coordinator will be regulating the 3 month phone call and scheduling the 6 month up visit and administering the Ohio Scales questionnaire with the parents and/ or guardians of the child. There will also be a 12 month follow-up phone call conducted by the research coordinator. During this time, the information for the C-SSRS questionnaire, the SIQ, the Ohio Scales (for both the parent and the child), the CGI-I, and the CGAS will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (ages 10-18 years) admitted to the Cleveland Clinic Inpatient Child and Adolescent psychiatry unit after a suicide ideation, behavior, or attempt.
- •This can be defined by any intentional, nonfatal self-injury, regardless of medical lethality, will be consider a suicide attempt if intent to die was indicated.
- •Signed consent by the adult patient (18 years) or by a first-degree relative or a guardian (for children) at the time of enrollment in the study, and assent by the children as soon as is feasible.
排除标准
- •Patients with a known history of autistic spectrum disorder, non-verbal patients and moderate or severe mental retardation (IQ less than 70 and those patients in special education full time), patients with substance dependency and patients with schizophrenia.
- •Patients who are enrolled in case management will also be excluded from the study.
结局指标
主要结局
Frequency of repeat suicide attempts in adolescents.
时间窗: up to 12 months post-discharge
Frequency of repeat suicide attempts during the 12 month follow up
次要结局
- Frequency of readmissions after a suicide attempt in adolescents.(up to 12 months post-discharge)
- Relation between service type and frequency of readmissions after a suicide attempt in adolescents.(up to 12 months post-discharge)
- Relation between service type and frequency of repeat suicide attempts in adolescents.(up to 12 months post-discharge)
研究者
Tatiana Falcone, MD
Tatiana Falcone M.D.
The Cleveland Clinic