Working Memory Training in Young ADHD Children - Full Text View

Sponsors and Collaborators:	Radboud University NWO
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00819611

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Behavioral: Cogmed Working memory training Behavioral: Control version of Cogmed working memory training	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Memory

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children

Further study details as provided by Radboud University:

Primary Outcome Measures:

ADHD criteria according to the DSM-IV-TR rated by the investigator [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurocognitive performance and electrocortical activity [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Working memory training: Experimental	Behavioral: Cogmed Working memory training 15 minutes of working memory training, 5 days a week for a period of 5 weeks
Control version of working memory training: Sham Comparator	Behavioral: Control version of Cogmed working memory training 15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks

Eligibility

Ages Eligible for Study:	54 Months to 88 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819611

Contacts

Contact: Martine Boomsma, MD	+31243512222	m.boomsma@psy.umcn.nl
Contact: Marieke Lansbergen, PhD	+31243613490	m.lansbergen@psy.umcn.nl

Locations

Netherlands
Karakter University Centre for Child and Adolescent Psychiatry Nijmegen
Nijmegen, Netherlands, 6525 GC

Sponsors and Collaborators

Radboud University

NWO

Investigators

Principal Investigator:

Dorine Slaats-Willemse, PhD

Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen

More Information

Publications:

Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlström 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.

Responsible Party:	Dept. of Psychiatry, Radboud University Nijmegen Medical Centre ( Prof. dr. J.K. Buitelaar )
Study ID Numbers:	WM01022009, RN000142
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819611 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

Attention deficit disorder with hyperactivity
Working memory training
Placebo

Behavioral symptoms
Neuropsychology
Electropsychophysiology

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations

Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias
Behavioral Symptoms

Additional relevant MeSH terms:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Nervous System Diseases
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

ClinicalTrials.gov processed this record on May 06, 2009