Clinical trial NCT00819611: Working Memory Training in Young ADHD Children
Official title: Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention deficit disorder with hyperactivity
Working memory training
Placebo
Behavioral symptoms
Neuropsychology
Electropsychophysiology
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2009-01-09
Enrollment: 51
Sex: ALL
Minimum age (years): 54
Maximum age (years): 88
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether working memory training improves behavioral symptoms, neurocognitive performance, and neural functioning in young children with ADHD.


Eligibility criteria: Inclusion Criteria:

* Age between 4 years/6 months and 7 years/4 months
* Diagnosis ADHD, classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000)
* A full scale IQ \>= 80
* Psychopharmaca- naïve or -free
* Access to a PC with Windows Vista or Windows XP with internet connection and speakers at home

Exclusion Criteria:

* Currently intensive (i.e. weekly) individual or group psychotherapy
* Regular use of medication
* Diagnosis of one or more of the following comorbid psychiatric disorders: Major depression, Bipolar disorder, Psychotic disorder, Chronically motor tic disorder or Gilles de la Tourette, Conduct disorder, any other autism spectrum disorder except for Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Eating disorders, Anxiety disorders
* Neurological disorders (e.g. epilepsy) currently or in the past
* Cardiovascular disease currently or in the past
* Serious motor or perceptual handicap
* Participation in another clinical trial simultaneously
* Educational level and/ or socio-economic situation that makes it unlikely for the family to fulfil this study

Primary outcomes:
measure: ADHD criteria according to the DSM-IV-TR rated by the investigator
timeFrame: 7 weeks
Secondary outcomes:
measure: Neurocognitive performance and electrocortical activity
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Karakter University Centre for Child and Adolescent Psychiatry Nijmegen
Study officials:
affiliation: Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
name: Dorine Slaats-Willemse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlstrom K, Gillberg CG, Forssberg H, Westerberg H. Computerized training of working memory in children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2005 Feb;44(2):177-86. doi: 10.1097/00004583-200502000-00010.
citation: van Dongen-Boomsma M, Vollebregt MA, Buitelaar JK, Slaats-Willemse D. Working memory training in young children with ADHD: a randomized placebo-controlled trial. J Child Psychol Psychiatry. 2014 Aug;55(8):886-96. doi: 10.1111/jcpp.12218. Epub 2014 Mar 15.