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临床试验/NL-OMON39279
NL-OMON39279
已完成
不适用

The effectiveness of a serious game for children with ADHD: A randomized, controlled, multicenter trial. - Serious gaming & ADHD

Janssen-Cilag0 个研究点目标入组 120 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Attention Deficit Hyperactivity Disorder (ADHD)
发起方
Janssen-Cilag
入组人数
120
状态
已完成
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Interventional

研究者

发起方
Janssen-Cilag

入排标准

入选标准

  • 1\. All children included in the study will be from 8 up to 12 years of age.
  • 2\. All children must have an official DSM\-IV ADHD diagnose (all subtypes). The diagnosis must have been previously set by a child and adolescent psychiatrist, a health care psychologist, clinical psychologist or a paediatrician specialised in social paediatrics. Children with common diagnosed co morbid disorders (i.e. dyslexia, oppositional defiant disorder) can participate in the study.
  • 3\. All participants need to be stable on ADHD treatment, both pharmacological and psychological, for at least two months prior to start of the intervention. All types of treatments, both pharmacological and psychological are accepted. Stable treatment can also include no pharmacological and psychological treatment. Whether subject receives stable ADHD treatment will be collected through self\-constructed questionnaire filled out by patents / legal guardians.
  • 4\. Minimum total intelligence quotient (TIQ) score must greater than or equal to 80\. If the total intelligence score is not known, has been established by a non\-COTAN approved test or has been performed more than two years previous to the start of the intervention, total intelligence score will be established using two subtests of the Wechsler Intelligence Scale for Children third version (WISC\-III\-NL; Wechsler, 2005\).
  • 5\. Children can only be included after a written informed consent has been signed by both parents or legal guardians , indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Twelve year olds must give their own written informed assent in addition to their parents/legal guardians.
  • 6\. The child and at least one of the parents/legal guardians must have a reasonable understanding of the Dutch language in order to understand the messages in the game, and have clear communication with the investigators.

排除标准

  • 1\. Children with a severe physical (i.e. Developmental Coordination Disorder), auditory (i.e. deafness), visual (i.e. blindness), neurological (i.e. epilepsy), speech and language (i.e. expressive receptive language disorder) or cognitive (i.e. mental handicap) disability will encounter great difficulties in playing HealSeeker, as will children with severe dyslexia (if they are not able to read texts), and are problematic for standardised measurements.
  • 2\. Furthermore, children who are addicted to drugs, alcohol and/or gaming, have conduct disorder (CD) or have severe acute psychiatric disorders, psychotic disorder, major depressive disorder and mania will be excluded.
  • 3\. Children with an Autism Spectrum Disorder and Pervasive Developmental Disorder \- Not Otherwise Specified.
  • 4\.Children that have previous played HealSeeker.

结局指标

主要结局

未指定

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