Attention Deficit Disorder With HyperactivityNCT02959528
The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
A study testing Working memory training and perceptual training in people with Attention Deficit Disorder With Hyperactivity and Psychophysiology, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Psychophysiology
- What is being tested?
- Working memory training and perceptual training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2015to 19 Jan 2017
- Phase
- Interventional
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD diagnosed according to criteria specified in Diagnostic and statistical manual of mental disorders (DSM-5)
- aged between 8 and 10 years
- intelligence quotient > 80 (based on Test of Nonverbal Intelligence-Third Edition)
- had normal or corrected-to-normal vision
- right-handed
Who cannot join
- diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
- history of seizures
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. One of these executive functions, working memory, plays a critical role in academic performance and classroom behavior. Working memory is essential for performing complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have shown that training of working memory has positive effects for ADHD and other cognitive disorder in children. However, transfer effects across studies appear to be variable and inconsistent. Event-related potentials can be a useful tool to gain insights into such mechanism. Therefore, the aim of the present study is to investigate both near and far transfer effects of N-back training in children with ADHD. In addition, the recording and analysis of event-related potentials will be adopted while children with ADHD perform the complex visuo-spatial and phonological working memory tasks.
- Being tested
- Working memory training, perceptual training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingOther
n-back training program
perceptual trainingOther
visual-perceptual training program
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | ADHD group treated with visual-perceptual training Receives: Other: perceptual training |
| Experiment | Experimental | ADHD group treated with working memory training Receives: Other: Working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Working Memory Assessment
Visuospatial working memory change after intervention measured by Automated Working Memory Assessment
Measured: 6 weeks
Secondary outcomes (2)
Working memory index in Wechsler Intelligence Scale for Children-IV
Verbal working memory change after intervention measured by Working memory index in WISC-IV
Measured: 6 weeks
Event-related potentials
Event-related potentials are measured brain response on effects of working memory training
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startOct 2015
- Primary completion25 Nov 2016
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-hsuan Shen, Chang Gung Memorial Hospital
- Investigators
- I-Hsuan Shen, PhD, Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959528
- Sponsor's protocol ID
- 104-5308A3
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02959528
- Acronym / sponsor ID
- 104-5308A3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 25 Nov 2016 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 9 Nov 2016 (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.
Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. One of these executive functions, working memory, plays a critical role in academic performance and classroom behavior. Working memory is essential for performing complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have shown that training of working memory has positive effects for ADHD and other cognitive disorder in children. However, transfer effects across studies appear to be variable and inconsistent. Event-related potentials can be a useful tool to gain insights into such mechanism. Therefore, the aim of the present study is to investigate both near and far transfer effects of N-back training in children with ADHD. In addition, the recording and analysis of event-related potentials will be adopted while children with ADHD perform the complex visuo-spatial and phonological working memory tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: perceptual trainingADHD group treated with visual-perceptual training |
| Experiment | Experimental | Other: Working memory trainingADHD group treated with working memory training |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ADHD diagnosed according to criteria specified in Diagnostic and statistical manual of mental disorders (DSM-5)
- aged between 8 and 10 years
- intelligence quotient > 80 (based on Test of Nonverbal Intelligence-Third Edition)
- had normal or corrected-to-normal vision
- right-handed
Key exclusion criteria (2 listed)
- diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
- history of seizures
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 |
|---|---|---|
| Working memory trainingn-back training program | Other | Experiment |
| perceptual trainingvisual-perceptual training program | Other | Control |
Primary outcome
Automated Working Memory Assessment
Time frame: 6 weeks
Visuospatial working memory change after intervention measured by Automated Working Memory Assessment
2 secondary outcomes
Working memory index in Wechsler Intelligence Scale for Children-IV
Time frame: 6 weeks
Event-related potentials
Time frame: 6 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 26 Oct 2017.
- Individual participant dataSharing planned: No
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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.
I-Hsuan Shen, PhD principal investigator
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory training and perceptual training in people with Attention Deficit Disorder With Hyperactivity and Psychophysiology, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 26 Oct 2017. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Automated Working Memory Assessment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2017.