- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819611
Working Memory Training in Young ADHD Children
January 9, 2014 updated by: Dorine Slaats, Radboud University Medical Center
Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nijmegen, Netherlands, 6525 GC
- Karakter University Centre for Child and Adolescent Psychiatry Nijmegen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ADHD criteria according to the DSM-IV-TR rated by the investigator
Time Frame: 7 weeks
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Neurocognitive performance and electrocortical activity
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dorine Slaats-Willemse, PhD, Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 8, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Estimate)
January 10, 2014
Last Update Submitted That Met QC Criteria
January 9, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WM01022009
- RN000142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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