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Working Memory Training in Young ADHD Children
This study has been completed.
Sponsor:
Radboud University
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: January 9, 2014
Last verified: January 2014
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
Further study details as provided by Dorine Slaats, Radboud University:
Primary Outcome Measures:
- ADHD criteria according to the DSM-IV-TR rated by the investigator [ Time Frame: 7 weeks ]
Secondary Outcome Measures:
- Neurocognitive performance and electrocortical activity [ Time Frame: 7 weeks ]
| Enrollment: | 51 |
| Study Start Date: | June 2009 |
| Study Completion Date: | December 2013 |
| 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
|
| 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
|
Eligibility| Ages Eligible for Study: | 54 Months to 88 Months (Child) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819611
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819611
Locations
| Netherlands | |
| Karakter University Centre for Child and Adolescent Psychiatry Nijmegen | |
| Nijmegen, Netherlands, 6525 GC | |
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | January 9, 2014 |
Keywords provided by Dorine Slaats, 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 Neurodevelopmental Disorders Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on September 19, 2017