Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01677832
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2012-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Executive Functions and Self-Regulation Among Children With and Without ADHD in Germany and Taiwan
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Neuronal Correlates of Executive Functions and Self-Regulation Among Children and Adolescents With and Without ADHD in Germany and Taiwan
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children and adolescents with ADHD are impulsive and have difficulties in regulating their behaviors. It has been suggested that a core deficit in inhibitory control may account for dysfunctional behaviors associated with this disorder. Previous research has shown that medication and the self-regulation strategy of making implementation intentions (i.e., if-then plans) are effective in enhancing children's inhibitory control, which is reflected in the behavioral as well as electrophysiological (e.g., Electroencephalogram; EEG) data on a Go/NoGo task in children with ADHD. As suggested by earlier research, however, forming implementation intentions may have different effects on people who are embedded in different cultures.
The aim of the present study is to compare the effects of medication and the self-regulation of forming implementation intentions by assessing the behavioral performance and corresponding brain activity during a Go/NoGo task in children and adolescents with and without ADHD under two different cultural contexts. Further, this study also aims at investigating the potential moderating effects of culture on making if-then plans. More important, as we know, this will be the first study to compare the effectiveness of forming implementation intentions on children and adolescents with ADHD in a cross-cultural way, which is meaningful for researchers to explore the degree of its application and expected to provide clinical psychologists an alternative perspective for ADHD treatment in the near future.
The aim of the present study is to compare the effects of medication and the self-regulation of forming implementation intentions by assessing the behavioral performance and corresponding brain activity during a Go/NoGo task in children and adolescents with and without ADHD under two different cultural contexts. Further, this study also aims at investigating the potential moderating effects of culture on making if-then plans. More important, as we know, this will be the first study to compare the effectiveness of forming implementation intentions on children and adolescents with ADHD in a cross-cultural way, which is meaningful for researchers to explore the degree of its application and expected to provide clinical psychologists an alternative perspective for ADHD treatment in the near future.
Detailed Description:
For a deeper understanding of the mechanism underlying the effects of MPH and implementation intentions, neurophysiological data (with a special interest on the P300 component) during a Go/NoGo task will be assessed additionally to the behavioral performance (i.e., response times and error rates). Meanwhile, the information may contribute to a better understanding of a potential influence of culture on the effect of implementation intentions. The effect may be equally effective in the cultures, but the underlying processes might still differ. On the other hand, differences between the two cultural groups might be explained by different neurophysiological activity during the tasks.
Two primary research questions arise: (1) Are MPH and implementation intentions (i.e., if-then plans) effective in enhancing the performance of executive function tasks measured by the Go/NoGo task in children and adolescents with ADHD compared with those without ADHD within each culture? (2) Does culture play a role in moderating the effect of implementation intentions on executive function tasks in children and adolescents with ADHD, respectively? Based on the research questions, two hypotheses are formulated. First, after the treatment of MPH and the self-regulation strategy of forming implementation intentions, it would result in less inhibition errors and more increased amplitudes of NoGo P300 and NoGominusGo P300 in children and adolescents with ADHD. Second, participants with ADHD in Taiwan may benefit more from the self-regulation strategy, which is reflected in more increased amplitudes of NoGo P300 and NoGominusGo P300 than found in their counterparts in Germany. However, since this is the first study to compare the effects of forming implementation intentions in a cross-cultural way, this latter analysis is more exploratory.
Two primary research questions arise: (1) Are MPH and implementation intentions (i.e., if-then plans) effective in enhancing the performance of executive function tasks measured by the Go/NoGo task in children and adolescents with ADHD compared with those without ADHD within each culture? (2) Does culture play a role in moderating the effect of implementation intentions on executive function tasks in children and adolescents with ADHD, respectively? Based on the research questions, two hypotheses are formulated. First, after the treatment of MPH and the self-regulation strategy of forming implementation intentions, it would result in less inhibition errors and more increased amplitudes of NoGo P300 and NoGominusGo P300 in children and adolescents with ADHD. Second, participants with ADHD in Taiwan may benefit more from the self-regulation strategy, which is reflected in more increased amplitudes of NoGo P300 and NoGominusGo P300 than found in their counterparts in Germany. However, since this is the first study to compare the effects of forming implementation intentions in a cross-cultural way, this latter analysis is more exploratory.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: