Gene and Environment in Schizophrenia- Research Groups in Madrid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- number of relapses
研究概览
简要总结
The AGES-CM consortium aims to study the interaction between the polymorphisms of the candidate genes related with neurodevelopment, neurotransmission, brain progressive changes, cognitive functioning and stressful life events (prospective- and retrospectively assessed) and the association of the interactions with structural and functional brain measures, neuropsychological performance, biochemical and oxidative status in both in patients and controls. The investigators study aimed to examine the effectiveness of a parallel, structured, and specific psychoeducational group intervention (PE) for adolescent patients and their families by comparing it with treatment as usual).
详细描述
Objective
To assess the effectiveness of a structured psychoeducational group intervention for adolescents with early onset psychosis and their families. The intervention was implemented in parallel in 2 separate groups, by focusing specifically on problem solving strategies and structured psychosis-related information to manage daily life hassles associated with the disease in order to manage crises and prevent relapses.
Method: The investigators performed a 9-month, randomized, rater-blind clinical trial involving adolescent patients with early onset psychosis and 1 or both of their parents. The primary outcomes were number of hospitalizations, days of hospitalization, and visits to the emergency department. The secondary outcome measures were clinical variables and family environment and well being.
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
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of at least one positive psychotic symptom (delusions or hallucinations)
- •Before age 18 diagnosed by DSM-IV
- •Aged between 14 and 19 years and lived at home with 1 or both parents, caregivers, or legal guardians.
排除标准
- •The exclusion criteria were patient's drug abuse or dependence at the time of the intervention (drug use was not an exclusion criterion), the presence of any neurological developmental disorder or mental retardation and inability to engage in conversation or read in Spanish that may interfere with the progress of group treatment.
研究组 & 干预措施
Psychoeducation Group
干预措施: Psychoeducation group treatment (Behavioral)
结局指标
主要结局
number of relapses
时间窗: Change from baseline to 1 -year follow-up and 2 years follow-up
次要结局
- clinical severity(1year 2 years)
研究者
Celso Arango
Head of Department
Hospital General Universitario Gregorio Marañon