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      Cognitive computer training in children with attention deficit hyperactivity disorder (ADHD) versus no intervention: study protocol for a randomized controlled trial

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          Abstract

          Background

          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.

          Discussion

          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.

          Trial registration

          ClinicalTrials.gov: NCT01752530, date of registration: 10 December 2012

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          Most cited references61

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          Computerized training of working memory in children with ADHD--a randomized, controlled trial.

          Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic practice of WM tasks. Included in the trial were 53 children with ADHD (9 girls; 15 of 53 inattentive subtype), aged 7 to 12 years, without stimulant medication. The compliance criterion (>20 days of training) was met by 44 subjects, 42 of whom were also evaluated at follow-up 3 months later. Participants were randomly assigned to use either the treatment computer program for training WM or a comparison program. The main outcome measure was the span-board task, a visuospatial WM task that was not part of the training program. For the span-board task, there was a significant treatment effect both post-intervention and at follow-up. In addition, there were significant effects for secondary outcome tasks measuring verbal WM, response inhibition, and complex reasoning. Parent ratings showed significant reduction in symptoms of inattention and hyperactivity/impulsivity, both post-intervention and at follow-up. This study shows that WM can be improved by training in children with ADHD. This training also improved response inhibition and reasoning and resulted in a reduction of the parent-rated inattentive symptoms of ADHD.
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            Attention-deficit/hyperactivity disorder is characterized by a delay in cortical maturation.

            There is controversy over the nature of the disturbance in brain development that underpins attention-deficit/hyperactivity disorder (ADHD). In particular, it is unclear whether the disorder results from a delay in brain maturation or whether it represents a complete deviation from the template of typical development. Using computational neuroanatomic techniques, we estimated cortical thickness at >40,000 cerebral points from 824 magnetic resonance scans acquired prospectively on 223 children with ADHD and 223 typically developing controls. With this sample size, we could define the growth trajectory of each cortical point, delineating a phase of childhood increase followed by adolescent decrease in cortical thickness (a quadratic growth model). From these trajectories, the age of attaining peak cortical thickness was derived and used as an index of cortical maturation. We found maturation to progress in a similar manner regionally in both children with and without ADHD, with primary sensory areas attaining peak cortical thickness before polymodal, high-order association areas. However, there was a marked delay in ADHD in attaining peak thickness throughout most of the cerebrum: the median age by which 50% of the cortical points attained peak thickness for this group was 10.5 years (SE 0.01), which was significantly later than the median age of 7.5 years (SE 0.02) for typically developing controls (log rank test chi(1)(2) = 5,609, P < 1.0 x 10(-20)). The delay was most prominent in prefrontal regions important for control of cognitive processes including attention and motor planning. Neuroanatomic documentation of a delay in regional cortical maturation in ADHD has not been previously reported.
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              Is working memory training effective?

              Working memory (WM) is a cognitive system that strongly relates to a person's ability to reason with novel information and direct attention to goal-relevant information. Due to the central role that WM plays in general cognition, it has become the focus of a rapidly growing training literature that seeks to affect broad cognitive change through prolonged training on WM tasks. Recent work has suggested that the effects of WM training extend to general fluid intelligence, attentional control, and reductions in symptoms of ADHD. We present a theoretically motivated perspective of WM and subsequently review the WM training literature in light of several concerns. These include (a) the tendency for researchers to define change to abilities using single tasks, (b) inconsistent use of valid WM tasks, (c) no-contact control groups, and (d) subjective measurement of change. The literature review highlights several findings that warrant further research but ultimately concludes that there is a need to directly demonstrate that WM capacity increases in response to training. Specifically, we argue that transfer of training to WM must be demonstrated using a wider variety of tasks, thus eliminating the possibility that results can be explained by task specific learning. Additionally, we express concern that many of the most promising results (e.g., increased intelligence) cannot be readily attributed to changes in WM capacity. Thus, a critical goal for future research is to uncover the mechanisms that lead to transfer of training.
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                Author and article information

                Contributors
                abikic@health.sdu.dk
                james.leckman@yale.edu
                JL@ctu.dk
                torbchri@rm.dk
                sdalsgaard@econ.au.dk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                24 October 2015
                24 October 2015
                2015
                : 16
                : 480
                Affiliations
                [ ]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
                [ ]Yale Child Study Centre, Yale University, 230 South Frontage Road, New Haven, USA
                [ ]Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
                [ ]Public Health and Quality Improvement, Central Denmark Region, Aarhus, Denmark
                [ ]Department of Economics and Business, National Centre for Register-based Research, Aarhus University, Fuglesangs Allé 4, Aarhus, Denmark
                Article
                975
                10.1186/s13063-015-0975-8
                4619562
                26499057
                15968db9-a3ae-4eb9-88c6-2c3f7d3b39bd
                © Bikic et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 July 2015
                : 24 September 2015
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Medicine
                adhd,cognitive training,cognitive remediation,cognition,computer training,nonpharmacological treatment

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