Enhancing Educational and Vocational Recovery in Adolescents and Young Adults With Early Psychosis Through Supported Employment and Education (SEE): A Randomized Controlled Trial. Acronym: SEEearly
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 8
- 主要终点
- Primary outcome
研究概览
简要总结
Psychotic disorders often develop a chronic course with devastating consequences for individuals, families, and societies usually with first onset during adolescence and early adulthood. Early intervention programs, which provide intensive, phase specific, psychosocial, and pharmacological treatment for people in the first five years after the initial psychotic episode (early psychosis) can significantly improve the outcome and are therefore strongly recommended in national and international guidelines. However, most early intervention programs in people with early psychosis still focus on improving symptoms and relapse prevention, rather than targeting educational and vocational recovery, although engagement in work and education is a high priority for young people with early psychosis and reduces the social disability associated with the disorder. The aim of the present study is to explore the effects of Supported Employment and Education (SEE) following the Individual Placement and Support (IPS) model in people with early psychosis. The investigators compare treatment as usual (TAU) in an outpatient psychiatric setting to TAU plus SEE.
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)
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of early psychosis (DSM 5: schizophrenia spectrum and other psychotic disorders (297.1, 298.8, 295.4, 295.9, 295.7, 298.8, 298.9) within the last 5 years currently treated as outpatients
- •sufficient linguistic and intellectual abilities to take part in the study
- •interest in competitive employment or/and mainstream education
- •written informed consent
排除标准
- •Learning disability or mental retardation as well as insufficient German language abilities (< A2)
- •physical or organic handicap that seriously impede work or educational functioning
结局指标
主要结局
Primary outcome
时间窗: 12 months
The primary outcome is the binary indicator "Participating steadily for at least 50% of the 12 month follow-up in competitive employment or/and mainstream education". Days in competitive employment or/and mainstream education will be assessed monthly. Competitive employment is defined as jobs that anyone can apply for regardless of disability status. It comprises part and full-time positions, as well as seasonal or temporary positions depending upon the business needs of the employer. Mainstream education is defined in accordance with OECD as educational programs that are certificating or rather degree bearing and open to the general public.
次要结局
- Length of competitive employment or/and mainstream education(12 months)
- Time to first competitive job/mainstream education(12 months)
- Monthly wages(12 months)
- Educational attainment(12 months)
- Social return on investment (SROI)(12 months)
- Subjective quality of life(12 months)
- Psychopathology(12 months)
- General substance abuse(12 months)
- Cannabis use(12 months)
- Relapse(12 months)
- Hospitalization(12 months)
- Functional impairment(12 months)
- Overall functional impairment(12 months)
研究者
Prof. Dr. med. Andreas Bechdolf
Professor
Charite University, Berlin, Germany