跳至主要内容
临床试验/NCT03437993
NCT03437993进行中(未招募)不适用

Recollect the Game: A Novel Treatment for Executive Functioning Deficits in Adults With ADHD

McMaster University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)

研究概览

简要总结

Adults who have attention deficit hyperactivity disorder (ADHD) suffer from significant occupational, academic and social problems, many of which are believed to be a result of problems with executive functioning. Executive functioning refers to a group of neuro-psychological functions which include sustained attention, working memory, verbal fluency, as well as motor and mental processing speed. Individuals with ADHD have been shown to have deficits in executive functioning independent of IQ, co-occurring psychiatric disorders, gender, and ADHD subtype. "Recollect" is an application (App) based working memory training video game where participants conduct 3-different adaptive working memory tasks. In each of these tasks participants are presented with a set of stimuli to be remembered while playing a simple platform game where they help navigate an astronaut across the screen and dodge obstacles. Recollect has been designed for all age groups to an interesting, fun and effective brain-training activity. The memory tasks included in the game have been independently shown to improve working memory in a manner that transfers to untrained tasks.

The purpose of this study is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult ADHD.

详细描述

The primary objective is to evaluate the effects of playing Recollect versus Tetris for 20 minutes per day, 5 days per week over a 4 week period, on executive functioning deficits in individuals who have Adult Attention Deficit Hyperactivity Disorder (ADHD).Consenting participants will be screened using the Mini International Neuropsychiatric Interview for DSM-5 (MINI) to confirm ADHD diagnosis. Participants will be asked to download either Recollect or Tetris on their own mobile device. Following a training/orientation session, they will be asked to spend 20 minutes per day at least 5 days per week playing Recollect or Tetris over a 4 week period. At Week 4, study staff will check the time log on the Recollect/Tetris App to confirm how much time was spent playing the game. Participants will be asked to complete two ADHD symptom severity scales, as well as App-based neurocognitive testing at baseline (Week 0) and endpoint (Week 4).

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females aged 18 and older who own a mobile device such as a Smartphone or tablet.
  • Current diagnosis of Adult ADHD, at any stage of treatment.
  • Comorbid psychiatric conditions will be allowed.
  • Medication or psychotherapy must have been stable (no dose changes) for 4 weeks prior to study participation.
  • Must be able to read, write and understand English.

排除标准

  • Participant does not own a Smartphone or tablet.
  • No dose changes during the 4 week study period.
  • No initiation of new psychological therapy or counselling during the 4 week study period.

结局指标

主要结局

Change from baseline on The Behavioral Rating Inventory of Executive Functioning - Adult Version (BRIEF-A)

时间窗: Change from baseline to week 4

It is a validated, clinician-rated scale, measuring executive functioning. The scale includes 75 items that rates patient symptoms on a 3-point Likert scale (1 = behavior is never observed to 3 = behavior is often observed). Scores range from 75 to 225: Higher scores indicate greater impairment in executive functioning.

次要结局

  • Change from baseline on the Barkley Adult ADHD Rating Scale (BAARS-IV)(Change from baseline to week 4)
  • Change from baseline on an App-based neuro-cognitive battery(Change from baseline to week 4)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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