Attention Deficit Disorder With HyperactivityPhase 4NCT00819611
Working Memory Training in Young ADHD Children
A Phase 4 study testing Cogmed Working memory training in people with Attention Deficit Disorder With Hyperactivity, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 54 to 88 months
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Cogmed Working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2009to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 54 to 88 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Karakter University Centre for Child and Adolescent Psychiatry Nijmegen
Nijmegen, 6525 GC
About this study
Official title: 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.
- Being tested
- Cogmed Working memory training, Control version of Cogmed working memory training
- Keywords
- Attention deficit disorder with hyperactivity, Working memory training, Placebo, Behavioral symptoms, Neuropsychology, Electropsychophysiology
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed Working memory trainingBehavioural
15 minutes of working memory training, 5 days a week for a period of 5 weeks
Control version of Cogmed working memory trainingBehavioural
15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Experimental | Not described Receives: Behavioral: Cogmed Working memory training |
| Control version of working memory training | Sham comparator | Not described Receives: Behavioral: Control version of Cogmed working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD criteria according to the DSM-IV-TR rated by the investigator
Measured: 7 weeks
Secondary outcomes (1)
Neurocognitive performance and electrocortical activity
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Responsible party
- Principal investigator, Dorine Slaats, Radboud University Medical Center
- Investigators
- Dorine Slaats-Willemse, PhD, Principal investigator, Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819611
- Sponsor's protocol ID
- WM01022009
- Other IDs
- RN000142
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2009
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15689731van 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.
PubMed 24628438
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training: A Randomised Controlled Treatment Study in Young ADHD Children
- ClinicalTrials.gov ID
- NCT00819611
- Acronym / sponsor ID
- WM01022009
- Keywords
- Attention deficit disorder with hyperactivity, Working memory training, Placebo, Behavioral symptoms, Neuropsychology, Electropsychophysiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Organisation for Scientific Research
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working memory training | Experimental | Behavioral: Cogmed Working memory training |
| Control version of working memory training | Sham comparator | Behavioral: Control version of Cogmed working memory training |
Who may qualify
- Ages
- 54 to 88 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmed Working memory training15 minutes of working memory training, 5 days a week for a period of 5 weeks | Behavioural | Working memory training |
| Control version of Cogmed working memory training15 minutes of 'sham' working memory training, 5 days a week for a period of 5 weeks | Behavioural | Control version of working memory training |
Primary outcome
ADHD criteria according to the DSM-IV-TR rated by the investigator
Time frame: 7 weeks
1 secondary outcome
Neurocognitive performance and electrocortical activity
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Background: PubMed 15689731Klingberg 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.
- Derived from this study: PubMed 24628438van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorine Slaats-Willemse, PhD principal investigator
Karakter University Centre for Child and Adolescent Psychiatry, Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cogmed Working memory training in people with Attention Deficit Disorder With Hyperactivity, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD criteria according to the DSM-IV-TR rated by the investigator (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.