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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov: NCT01752530 , date of registration: 10 December 2012.
Institute of Clinical Research, University of Southern Denmark, Winsløwsparken 19, Odense, Denmark. abikic@health.sdu.dk.|Department of Child and Adolescent Mental Health Services, Psychiatric Hospital Region of Southern Denmark, Kresten Phillipsens Vej 15, Aabenraa, Denmark. abikic@health.sdu.dk.|Yale Child Study Centre, Yale University, 230 South Frontage Road, New Haven, USA. abikic@health.sdu.dk.
Aida
A
Bikic
Yale Child Study Centre, Yale University, 230 South Frontage Road, New Haven, USA. james.leckman@yale.edu.
James F
JF
Leckman
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. JL@ctu.dk.
Jane
J
Lindschou
Public Health and Quality Improvement, Central Denmark Region, Aarhus, Denmark. torbchri@rm.dk.
Torben Ø
TØ
Christensen
Department of Economics and Business, National Centre for Register-based Research, Aarhus University, Fuglesangs Allé 4, Aarhus, Denmark. sdalsgaard@econ.au.dk.
Søren
S
Dalsgaard
D000293:Adolescent; D000294:Adolescent Behavior; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002648:Child; D002652:Child Behavior; D002985:Clinical Protocols; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000295:instrumentation*; D003718:Denmark; D005260:Female; D006801:Humans; D008297:Male; D008570:Memory, Short-Term; D012107:Research Design; D013813:Therapy, Computer-Assisted / Q000295:instrumentation*; D013997:Time Factors; D016896:Treatment Outcome