- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02959528
The Effects of Working Memory Training in Children With Attention-Deficit/Hyperactivity Disorder
October 25, 2017 updated by: I-hsuan Shen, Chang Gung Memorial Hospital
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
-
Taoyuan City, Taiwan
- Chang Gung University
-
-
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
8 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
- history of seizures
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
ADHD group treated with visual-perceptual training
|
visual-perceptual training program
|
|
Experimental: Experiment
ADHD group treated with working memory training
|
n-back training program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Automated Working Memory Assessment
Time Frame: 6 weeks
|
Visuospatial working memory change after intervention measured by Automated Working Memory Assessment
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Working memory index in Wechsler Intelligence Scale for Children-IV
Time Frame: 6 weeks
|
Verbal working memory change after intervention measured by Working memory index in WISC-IV
|
6 weeks
|
|
Event-related potentials
Time Frame: 6 weeks
|
Event-related potentials are measured brain response on effects of working memory training
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: I-Hsuan Shen, PhD, Chang Gung University
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
October 1, 2015
Primary Completion (Actual)
November 25, 2016
Study Completion (Actual)
January 19, 2017
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
November 7, 2016
First Posted (Estimate)
November 9, 2016
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104-5308A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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