Family Motivational Intervention in Schizophrenia (FMI)
Motivational Interviewing and Interaction Skills Training for Carers to Change Cannabis Use in Young Adults With Recent-onset Schizophrenia: Randomised Controlled Trial
Cannabis use by people with schizophrenia is associated with family distress and poor clinical outcomes. Therefore, an Family Motivational Intervention (FMI) was developed to help parents to motivate their child with a diagnoses of recent-onset schizophrenia to reduce cannabis use.
In a single-blind randomised clinical trail with 75 patients with the diagnosis of schizophrenia, parents will be assigned to either FMI or to routine care. Assessments will be conducted at baseline and at a 10- and 22-month follow-up. The study hypothesis is that FMI will be more effective than routine care in reducing (a) cannabis use in patients and (b) distress and sense of burden in parents.
研究概览
研究类型
介入性
注册 (实际的)
147
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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North Holland
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Amsterdam、North Holland、荷兰、1066 DP
- Academic Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 40年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of schizophrenia or psychotic-related disorder
- Onset of schizophrenia or related disorder within pervious the 10 years
- Cannabis use at least 2 days per week in the 3 months prior to the assessment
- Antipsychotic medication in prescribed or indicated
- At least 10 hours of contact with the parents each week in the last month
Exclusion Criteria:
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学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Family Motivational Intervention
An intervention provided to parents consisting of 6 sessions of training in Interactions Skills and 6 sessions training in Motivational Interviewing.
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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有源比较器：Routine care for parents
Routine care for parents consisting of 2 sessions psycho-education and individual support
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A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
大体时间：Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
大体时间：10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Cannabis use in patients with a diagnosis of recent-onset schizophrenia
大体时间：22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
大体时间：Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
大体时间：10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Medication adherence in patients with a diagnosis of recent-onset schizophrenia
大体时间：22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
大体时间：Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Quality of life in patients with recent-onset schizophrenia
大体时间：10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Quality of life in patients with recent-onset schizophrenia
大体时间：22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Stress in parents due to caring for a child with recent-onset schizophrenia
大体时间：Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Stress in parents due to caring for a child with recent-onset schizophrenia
大体时间：10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Stress in parents due to caring for a child with recent-onset schizophrenia
大体时间：22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
大体时间：Baseline (before the start of the intervention)
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Baseline (before the start of the intervention)
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Expressed emotion in parents of patients with recent-onset schizophrenia
大体时间：10-month follow-up (3 months after the intervention has ended)
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10-month follow-up (3 months after the intervention has ended)
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Expressed emotion in parents of patients with recent-onset schizophrenia
大体时间：22-month follow-up (15 months after the intervention has ended)
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22-month follow-up (15 months after the intervention has ended)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Gerard Schippers, Prof. dr.、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 首席研究员：Don Linszen, Prof.dr.、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 学习椅：Lieuwe de Haan, Dr.、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年3月1日
初级完成 (预期的)
2010年8月1日
研究完成 (预期的)
2011年2月1日
研究注册日期
首次提交
2010年7月20日
首先提交符合 QC 标准的
2010年7月21日
首次发布 (估计)
2010年7月22日
研究记录更新
最后更新发布 (估计)
2010年7月22日
上次提交的符合 QC 标准的更新
2010年7月21日
最后验证
2008年2月1日
更多信息
与本研究相关的术语
其他研究编号
- Grant 100003014
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.