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临床试验/NCT02732496
NCT02732496已完成不适用

Computerized Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder and Comorbid Tourette Syndrome

Massachusetts General Hospital0 个研究点目标入组 20 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

研究概览

简要总结

The investigators will conduct a randomized placebo-controlled trial of a computerized intervention targeting working memory in 30 children with comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS).

详细描述

Because impairments in executive functions (EFs), such as working memory, are associated with functional impairments in youth with neurodevelopmental and neuropsychiatric disorders, strategies that target EFs are critical. Neuroplasticity-based cognitive training has been found to improve cognition in youth with ADHD and in adults with schizophrenia. In this trial, the investigators seek to extend the relevance of computerized cognitive training to youth with comorbid ADHD and Tourette Syndrome. Given the literature, the investigators hypothesize that computerized working memory training will produce gains in untrained cognitive tasks and behavioral ratings of executive functions in youth with ADHD+TS. The investigators will assess aspects of attention and executive functions in 30 affected youth and randomize them 1:1 to either neuroplasticity-based cognitive training or enjoyable age-appropriate computer games not intended to improve cognition. Cognition will be assessed again after 30 training sessions over 6 weeks and then again at a one-month follow-up.

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
Double (Participant, Investigator)

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The investigators will limit inclusion to youth between the ages of 7-13 who carry current diagnoses of ADHD+TS and who have a treating physician at a Partners affiliated hospital or clinic.
  • The investigators will include youth who have undergone neuropsychological testing in the prior 3 years.

排除标准

  • The investigators will exclude patients with intellectual disability in order to more directly extend the prior literature to the ADHD+TS population.
  • The investigators will exclude patients with severe tics as evidenced by a score of > 30 on the clinician administered Yale Global Tic Severity Scale (YGTSS).
  • The investigators will exclude patients with moderate to severe Obsessive Compulsive Disorder (OCD) symptoms, as evidenced by a score of >30 on the clinician administered Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS).
  • The investigators will exclude patients treated with neuroleptics, given that these medications can be cognitively dulling and sedating and potentially lead to secondary working memory impairments.
  • The investigators will exclude families who do not have a computer with an internet connection in their homes, and in which neither a parent nor the child has an email address to receive study related communications.
  • The investigators will exclude families who anticipate or are likely to have a change in therapeutic treatments (i.e., psychotherapy or psychopharmacology) during the time frame of the trial.
  • NOTE: Patients treated with ADHD medications will not be excluded, but medications will be recorded for covariate analysis.

研究组 & 干预措施

Cognitive Training

Experimental

Targeted Cognitive Training (TCT)

干预措施: Targeted Cognitive Training (TCT) (Behavioral)

Youth Appropriate Online Games

Placebo Comparator

Engaging games not designed to improve cognition

干预措施: Youth Appropriate Online Games (Other)

结局指标

主要结局

Spatial Span (SSP) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

时间窗: 3 months

The SSP subtest assesses working memory.

The Working Memory Index from the Behavior Rating Inventory of Executive Function (BRIEF)

时间窗: 3 months

Parent and teacher ratings on the Working Memory Index of the BRIEF assess working memory.

Spatial Working Memory (SWM) subtest from the Cambridge Neuropsychological Test Automated Battery (CANTAB)

时间窗: 3 months

The SWM subtest assesses working memory.

The Behavioral Regulation Index from the Behavior Rating Inventory of Executive Function (BRIEF)

时间窗: 3 months

Parent and teacher ratings on the Behavioral Regulation Index of the BRIEF assess working memory.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Zelime Elibol

Instructor in Neurology, Harvard Medical School

Massachusetts General Hospital

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