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Working Memory Training in Young ADHD Children

This study is currently recruiting participants.
Verified November 2012 by Radboud University
Sponsor:
Collaborator:
Netherlands Organisation for Scientific Research
Information provided by (Responsible Party):
Dorine Slaats, Radboud University
ClinicalTrials.gov Identifier:
NCT00819611
First received: January 8, 2009
Last updated: November 30, 2012
Last verified: November 2012
History of Changes
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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: June 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Working memory training Behavioral: Cogmed Working memory training
15 minutes of working memory training, 5 days a week for a period of 5 weeks
Other Name: Cogmed Working memory training
Sham Comparator: Control version of working memory training 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
Other Name: Control version of Cogmed working memory training

  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 van Dongen-Boomsma, MD +31243512222 m.boomsma@psy.umcn.nl
Contact: Martine van Dongen-Boomsma, MD +31243613490 m.boomsma@psy.umcn.nl

Locations
Netherlands
Karakter University Centre for Child and Adolescent Psychiatry Nijmegen Recruiting
Nijmegen, Netherlands, 6525 GC
Contact: Secretary     +31243512222        
Sponsors and Collaborators
Radboud University
Netherlands Organisation for Scientific Research
Investigators
Principal Investigator: Dorine Slaats-Willemse, PhD Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
  More Information

Publications:

Responsible Party: Dorine Slaats, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT00819611     History of Changes
Other Study ID Numbers: WM01022009, RN000142
Study First Received: January 8, 2009
Last Updated: November 30, 2012
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013