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临床试验/NCT03160378
NCT03160378Unknown不适用

Organizational Skills Training for Children With ADHD

Region Syddanmark2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2017年5月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
142
试验地点
2
主要终点
Children Organizational Skills Scale (COSS)-parent

研究概览

简要总结

The purpose of this trial is to investigate the effect of organizational skills training, a parent and child training approach on organizational skills, inattentive symptoms and functional outcome in children age 6-13 years. Half of the participants will receive treatment as usual (TAU) and organizational skills training and the other half will receive TAU.

详细描述

Organizational skills training (OST) is a behavioral intervention that has been increasingly used to address difficulties with time management and organization of materials in children with ADHD, that tend to persist despite medication and behavioral treatments. This randomized clinical superiority trial is going to investigate the effect of Organizational Skills Training, a group treatment approach for parents and children. The program is also involving a computerized program, vTime, that will help the children manage time more effectively. A total of 98 children with ADHD aged 6-13 years is expected to be randomized to either intervention or control group in a single blind design. Both groups will receive treatment-as-usual. The intervention group is going to participate in a group training for parents and children for 10 weekly sessions.

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
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ADHD diagnosis after clinical interview K-SADS
  • age between 6-13 years, both inclusive; informed consent.
  • The child has to score at least one standard deviation (SD) above the mean on the Plan/Organize subscale on the Behavior Rating Inventory of Executive Functions (BRIEF) (parent edition) verifying problems with organizational skills.

排除标准

  • autism spectrum disorder
  • serious psychopathology requiring immediate clinical attention (e.g., severe depression or aggressive behavior)
  • head injury or verified neurological disease
  • intelligence quotient (IQ <80)
  • medical condition, requiring primary treatment
  • no informed consent from custody.

结局指标

主要结局

Children Organizational Skills Scale (COSS)-parent

时间窗: after 10 weeks of intervention

organizational skills questionnaire

次要结局

  • ADHD-Rating Scale (ADHD-RS) (parent edition)(after 10 weeks of intervention)
  • Behavior Rating Inventory of Executive Functions (BRIEF)-parent(after 10 weeks of intervention)
  • Children Organizational Skills Scale (COSS)-teacher(after 10 weeks of intervention)
  • CANTAB Rapid Visual Movement (RVP)(after 10 weeks of intervention)
  • Weis's scale of disability-Parent Report (WFIRS-P)(after 10 weeks of intervention)

研究者

发起方
Region Syddanmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aida Bikic

Ph.D., clinical psychologist

Region Syddanmark

研究点 (2)

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