Young Adults With Violent Behavior During Early Psychosis: An Open Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Feasibility of Intervention Measure (FIM)
研究概览
简要总结
This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.
详细描述
The investigators will conduct an open pilot trial of a behavioral intervention to reduce violent behavior within the OnTrackNY network. The focus of this open pilot is to explore the acceptability and feasibility of the intervention. The study will enroll early intervention service (EIS) clinician - EIS participant dyads. The planned sample size is 3-4 EIS clinicians and 10-16 EIS participants (up to n=16 dyads). This real-world open pilot will provide feedback to help tailor the intervention to the OnTrackNY setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for EIS participants:
- •Ages 16 to 30 who have experienced nonaffective psychosis with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, other specified/unspecified schizophrenia spectrum and other psychotic disorders (International Classification of Disease Clinical Modification (ICD-10-CM) Diagnosis Code F20.x)
- •Receive First Episode Psychosis (FEP) treatment in one of OnTrackNY clinics/sites with an eligible EIS clinicians
- •Willing to participate in research interviews after each study visit during the study period
排除标准
- •Unable to provide informed consent
- •Not fluent (speaking, reading, writing) in English
研究组 & 干预措施
behavioral intervention
This will involve conducting a 12-week open pilot trial (up to n=16 dyads of EIS clinicians-EIS participants) to test the feasibility and acceptability of the adapted Psychological Interventions for Coping with Anger and Schizophrenia: a study of outcomes (PICASSO) intervention in the OnTrackNY setting.
干预措施: adapted behavioral intervention (Behavioral)
结局指标
主要结局
Mean Feasibility of Intervention Measure (FIM)
时间窗: 12 weeks
The FIM is a 4-item measure of the feasibility of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high feasibility.
Mean Acceptability of Intervention Measure (AIM)
时间窗: 12 weeks
The AIM is a 4-item measure of the acceptability of the intervention, to be completed by EIS clinicians. Scores range from 1-4 with higher score indicating high acceptability.
Number of EIS Participants in Attendance
时间窗: 12 weeks
The number of EIS participants that attend the cognitive behavioral therapy sessions.
次要结局
未报告次要终点
研究者
Paul S. Appelbaum
Elizabeth K. Dollard Professor of Psychiatry, Medicine and Law
Columbia University