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临床试验/NCT02610244
NCT02610244终止不适用

Examining Benefits of Modified Cogmed Training With ADHD Youth at Cambridge Memorial Hospital (CMH)

Cambridge Memorial Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
40
试验地点
2
主要终点
Change assessed on Wiat-111 Reading comprehension and math problem-solving

研究概览

简要总结

ADHD youth (8-16 years) will be randomized to either treatment-as-usual group or a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objectives are to determine whether there is improvement in working memory and attention, a reduction in concerns related to ADHD and social emotional behaviour,and transfer effects for reading and math following participation in our MCT.

详细描述

The Cogmed working memory training program consists of 5 daily 50-min sessions for 5 weeks. This program has been identified as a promising intervention for youth with Attention Deficit Hyperactivity Disorder (ADHD) who have deficits in aspects of executive functioning (EF), such as working memory (WM) and attention (ATT), as well as social-emotional behavior (SEB). Findings regarding the efficacy and generalization of transfer effects associated with Cogmed have been mixed, possibly due to methodological limitations of the standard program. In our study, these limitations will be addressed with ADHD youth (8-16 years) in a randomized controlled trial using a modified version of the Cogmed program (MCT) that is suitable for use in a hospital setting (duration = 3 daily 35-min sessions for 10 weeks). The main objective is to determine whether there is improvement in WM and ATT, a reduction in concerns related to ADHD and SEB, and transfer effects for reading and math following participation in our MCT.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Youth who are between 8-16 years age.
  • Youth with a primary diagnosis of ADHD per psychiatric and psychological assessment.
  • Youth with an estimated Intelligence Quotient (IQ) equal or greater than 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-
  • Youth with reading comprehension at or above a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III).
  • Youth who are receiving medication will have made an adequate adjustment to their medication as shown by stable blood levels, psychiatric consultation, and self and parent report at least 2 weeks prior to the start of their acceptance into this study.

排除标准

  • Youth who are younger than 8 or older than 16 at the time of enrollment.
  • Youth who do not have a primary diagnosis of ADHD.
  • Youth with an estimated Intelligence Quotient (IQ) below 80 on an intelligence measure (Wechsler Abbreviated Scale of Intelligence; WASI), where the average IQ varies from 90-
  • Children with intellectual functioning below this level have been found to have trouble following instructions that are necessary for the training program.
  • Youth with reading comprehension below a grade 2 level on a standardized reading test (Wechsler Individual Achievement Test - 3rd Edition; WIAT-III). Children with reading skills below this level have been found to have trouble following instructions that are necessary for the training program.
  • Youth do not intend to begin new medication, discontinue existing medication, or change dose in medication - unless indicated per their doctor's instructions - for the duration of their involvement in the study.
  • Youth cannot be accepted into the study if they have a significant medical impairment that would preclude their participation, a significant uncorrected visual/hearing deficit that would make it difficult for them to see a computer screen and follow verbal instructions, and/or a significant problem with their fine motor control that would make it difficult for them to use a keyboard.

结局指标

主要结局

Change assessed on Wiat-111 Reading comprehension and math problem-solving

时间窗: Baseline,10 weeks, 3 months

Reading Comprehension and Math problem-solving measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Change assessed on Tova Attention Performance Index

时间窗: Baseline,10 weeks, 3 months

Attention Performance Index measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Changes assessed for Working Memory Index (BRIEF measure) and working memory (verbal and Visual-spatial) as measured on Alloway Working Memory Test

时间窗: Baseline,10 weeks, 3 months

The BRIEF Parent/Teacher ratings of youth's working memory index and Youth 's scores on Alloway Working Memory test at baseline will be compared with scores after 10 weeks modified cogmed training or treament-as-usual, and after 3 months

Changes assessed on Beck Self-Concept

时间窗: Baseline,10 weeks, 3 months

Self-concept measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

Change assessed on Achenbach Reduction in Total Problems Scale

时间窗: Baseline,10 weeks, 3 months

Total Problem scale measures will be compared from baseline to after completing Cogmed training and at 3 month follow up.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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