Mindfulness-based Program for Children With Disruptive Behavior Disorder
追踪信息 | |||
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首次提交日期 ICMJE | June 20, 2018 | ||
首次发布日期e ICMJE | October 5, 2018 | ||
最后更新发布日期 | October 5, 2018 | ||
预计研究开始日期 ICMJE | October 4, 2018 | ||
预计主要完成日期 | May 1, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in behavioral problems at school[ Time Frame: One week before the start of the intervention, one week after the end of the intervention, and 6 months after the end of the intervention. ] Strengths and Difficulties Questionnaire Strength and Difficulties Questionnaire (SDQ) is one of the most frequently used behavioral rating scale in educational, research, and clinical settings for assessing emotional and behavioral patterns in childhood. This 25-item questionnaire measures psychological adjustment in 3- to 16-year-olds in five subdomains. Of these, four subscales measure difficulties (conduct problems, hyperactivity, emotional problems, and peer relational problems), while the fifth measures strengths (prosocial behavior). There are three versions of the scale (a parent, teacher, and self-report). Change in Aggressive behaviors[ Time Frame: One week before the start of the intervention, one week after the end of the intervention, and 6 months after the end of the intervention. ] Modified Overt Aggression Scale The MOAS (Kay et al., 1988) is a clinician administered scale that measures four types of overt aggression over the past week: verbal aggression, physical aggression against property, auto-aggression, and physical aggression against other people. Change in Behavioral problems at home[ Time Frame: One week before the start of the intervention, one week after the end of the intervention, and 6 months after the end of the intervention. ] Child Behavior Check List It is a 118 item standardized format, completed by parents for recording behavioural problems and skills in children 6 to 18 years of age. The 118 behaviour problem items are aggregated in eight different subscales related to both Internalizing and Externalizing domains. Change in impulsiveness[ Time Frame: One week before the start of the intervention, one week after the end of the intervention, and 6 months after the end of the intervention. ] Matching Familiar (MF-20) test from Italian Battery for ADHD (Marzocchi, Re, & Cornoldi, 2010). In the Matching Familiar Figures (MF) test, participants are shown a figure and are asked to find the matching one among six choices. This task measures the children's impulsiveness. The MF test includes 20 items. Clinicians sum children's score in accuracy and latency time to arrive at one reported value, that is the children's impulsiveness score. Change in sustained attention capacities[ Time Frame: One week before the start of the intervention, one week after the end of the intervention, and 6 months after the end of the intervention. ] Bells Test Revised The Bells Test revised (Biancardi & Stoppa, 1997) is a test for the evaluation of sustained attention in children. The test is an adaptation of Gauthiers's Bell Test used to assess neglect in adults. The Bells Test has been modified in order to make it suitable to research in developmental age. Items are organized in four different pages, which include each 35 bells. Speed and Accuracy in selecting the target stimuli (bells) are assessed. The Speed score refers to the number of bells found by the child in the first 30 seconds of the task, while the Accuracy score refers to the total number of bells found during the whole task (120 seconds). |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Mindfulness-based Program for Children With Disruptive Behavior Disorder | ||
正式标题 ICMJE | Mindfulness-based Program for Children With Disruptive Behavior Disorder | ||
简要概况 | The present RCT study investigates whether combined mindfulness program for children and their parents was beneficial for Italian children, aged 8-12, with disruptive behavior diagnosis (DBD). The study tests the program effects on children's behavioral difficulties in school and home contexts; children's and parents' mindfulness abilities; children's impulsiveness; and parents' stress. The study include a sample of 60 children randomly allocate to the intervention or to the control condition (wait-list control sample). Repeated measures of children's and parents' and teachers' reported measures will be used. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Crossover Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
60 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | June 1, 2020 | ||
预计主要完成日期 | May 1, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Disruptive Behavior primary diagnosis Exclusion Criteria: - IQ < 80 - ASD diagnosis - ongoing other interventions | ||
性别 |
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年龄 | 最小年龄:8 Years ,最大年龄:12 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Italy | ||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | IRCCS Fondazione Stella Maris | ||
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研究员 ICMJE |
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验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |