Bikic Aida, Leckman James F, Lindschou Jane, Christensen Torben Ø, Dalsgaard Søren
Institute of Clinical Research, University of Southern Denmark, Winsløwsparken 19, Odense, Denmark.
Department of Child and Adolescent Mental Health Services, Psychiatric Hospital Region of Southern Denmark, Kresten Phillipsens Vej 15, Aabenraa, Denmark.
Trials. 2015 Oct 24;16:480. doi: 10.1186/s13063-015-0975-8.
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by symptoms of inattention and impulsivity and/or hyperactivity and a range of cognitive dysfunctions. Pharmacological treatment may be beneficial; however, many affected individuals continue to have difficulties with cognitive functions despite medical treatment, and up to 30 % do not respond to pharmacological treatment. Inadequate medical compliance and the long-term effects of treatment make it necessary to explore nonpharmacological and supplementary treatments for ADHD. Treatment of cognitive dysfunctions may prove particularly important because of the impact of these dysfunctions on the ability to cope with everyday life. Lately, several trials have shown promising results for cognitive computer training, often referred to as cognitive training, which focuses on particular parts of cognition, mostly on the working memory or attention but with poor generalization of training on other cognitive functions and functional outcome. Children with ADHD have a variety of cognitive dysfunctions, and it is important that cognitive training target multiple cognitive functions.
METHODS/DESIGN: This multicenter randomized clinical superiority trial aims to investigate the effect of "ACTIVATE™," a computer program designed to improve a range of cognitive skills and ADHD symptoms. A total of 122 children with ADHD, aged 6 to 13 years, will be randomized to an intervention or a control group. The intervention group will be asked to use ACTIVATE™ at home 40 minutes per day, 6 days per week for 8 weeks. Both intervention and control group will receive treatment as usual. Outcome measures will assess cognitive functions, symptoms, and behavioral and functional measures before and after the 8 weeks of training and in a 12- and 24-week follow-up.
Results of this trial will provide useful information on the effectiveness of computer training focusing on several cognitive functions. Cognitive training has the potential to reduce cognitive dysfunctions and to become a new treatment option, which can promote a more normal neural development in young children with ADHD and thus reduce cognitive dysfunctions and symptoms. This could help children with ADHD to perform better in everyday life and school.
ClinicalTrials.gov: NCT01752530 , date of registration: 10 December 2012.
注意力缺陷多动障碍（ADHD）是一种常见的神经发育障碍，其特征为注意力不集中、冲动和/或多动症状以及一系列认知功能障碍。药物治疗可能有益；然而，许多受影响的个体尽管接受了药物治疗，但在认知功能方面仍存在困难，高达30%的患者对药物治疗无反应。医疗依从性不足以及治疗的长期影响使得有必要探索ADHD的非药物和辅助治疗方法。由于这些功能障碍对日常生活应对能力的影响，治疗认知功能障碍可能尤为重要。最近，几项试验显示认知计算机训练（通常称为认知训练）取得了有希望的结果，这种训练侧重于认知的特定部分，主要是工作记忆或注意力，但对其他认知功能和功能结果的训练泛化性较差。ADHD儿童存在多种认知功能障碍，认知训练针对多种认知功能很重要。
方法/设计：这项多中心随机临床优势试验旨在研究“ACTIVATE™”（一种旨在提高一系列认知技能和ADHD症状的计算机程序）的效果。共有122名6至13岁的ADHD儿童将被随机分为干预组或对照组。干预组将被要求在家中每天使用ACTIVATE™ 40分钟，每周6天，共8周。干预组和对照组都将接受常规治疗。结果测量将在8周训练前后以及12周和24周随访时评估认知功能、症状以及行为和功能指标。
该试验结果将为聚焦多种认知功能的计算机训练的有效性提供有用信息。认知训练有可能减少认知功能障碍，并成为一种新的治疗选择，这可以促进ADHD幼儿更正常的神经发育，从而减少认知功能障碍和症状。这可以帮助ADHD儿童在日常生活和学校中表现得更好。
ClinicalTrials.gov：NCT01752530，注册日期：2012年12月10日。
