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临床试验/NCT01675804
NCT01675804已完成3 期

A Randomized Clinical Trial Comparing Computer-assisted Cognitive Rehabilitation (CACR), Psycho-stimulants, and Placebo CACR in the Treatment of Attention Deficit/ Hyperactivity Disorder

Allameh Tabatabai University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Forward/Reversed digit span tasks from the WISC-R testing battery.

研究概览

简要总结

Current research aimed to compare the efficacy of computer-assisted cognitive rehabilitation (CACR), stimulant drugs and Placebo CACR on executive functions and clinical symptoms of children with attention deficit/hyperactivity disorder (ADHD).

详细描述

The investigators administered a randomized controlled trial (RCT) through random assignment of ADHD subjects in to three different groups to compare the effects of CACR, immediate-release methylphenidate, and a Placebo CACR (i.e. some computerized tasks assumed not having any therapeutic effects) on the functioning of children with ADHD.

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
7 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • ADHD diagnosis
  • age between 7 and 12

排除标准

  • sever co-morbid disorder
  • disability
  • sever medical condition

研究组 & 干预措施

Computerized cognitive rehabilitation

Experimental

-Computer-assisted cognitive rehabilitation (CACR): 20 Ninety-minute sessions of CACR.

干预措施: Computerized cognitive rehabilitation (Other)

Placebo CACR [PCACR]

Placebo Comparator

-PCACR group simultaneously received 20 Ninety-minute sessions of Placebo CACR.

干预措施: Placebo CACR [PCACR] (Other)

Ritalin

Experimental

-2 to 3 doses of 10 mg Ritalin tablets per day during two months.

干预措施: Ritalin (Drug)

结局指标

主要结局

Forward/Reversed digit span tasks from the WISC-R testing battery.

时间窗: 5 months

Reversed digit span from the WISC-R (Wechsler, 1974) was used to measure executive verbal WM and the forward digit span was used to measure short-term memory.

Raven's colored progressive matrices.

时间窗: 5 months

Raven's colored progressive matrices (Raven, 1995) was used to measure complex non-verbal reasoning.

Persian software for the continuous performance test [CPT]

时间窗: 5 months

The Persian software of CPT is a visual CPT test.

Persian software for the Tower of London Test [TOL]

时间窗: 5 months

Persian TOL is a software version of tower of London test (TOL) which was developed in Iran.

Span board task from the Lumosity.com online software (Lumosity.com, 2012)

时间窗: 5 months

SNAP-IV scales

时间窗: 5 months

次要结局

未报告次要终点

研究者

发起方
Allameh Tabatabai University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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