Attention-Deficit/Hyperactivity DisorderNCT01677832
Executive Functions and Self-Regulation Among Children With and Without ADHD in Germany and Taiwan
An observational study of Attention-Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2012to 31 Dec 2014
- Phase
- Observational
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited respectively in Germany and Taiwan using the same standardized procedures according to the protocol. Children and adolescents with and without ADHD between the ages 10 to 14, with an IQ full score ≥ 80, will participate in this study. Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before enrolment. They are diagnosed with ADHD combined subtype and have no comorbid disorders. None of the controls are clinically diagnosed with any disorders and take any medication. Both samples should be matched according to the variables: gender, IQ, and socio-economic status (SES).
Who may be able to join
- Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before enrolment.
- Participants with ADHD are diagnosed with ADHD combined subtype.
- Ages range from 10 to 14 when we conduct the study.
- IQ full score ≥ 80.
Who cannot join
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuronal Correlates of Executive Functions and Self-Regulation Among Children and Adolescents With and Without ADHD in Germany and Taiwan
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.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD/Taiwan | Not described | |
| Control/Taiwan | Not described | |
| ADHD/Germany | Not described | |
| Control/Germany | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start1 Jan 2012
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677832
- Sponsor's protocol ID
- 201201062RIB
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2012
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Correlates of Executive Functions and Self-Regulation Among Children and Adolescents With and Without ADHD in Germany and Taiwan
- ClinicalTrials.gov ID
- NCT01677832
- Acronym / sponsor ID
- 201201062RIB
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 3 Sep 2012 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADHD/Taiwan | – | – |
| Control/Taiwan | – | – |
| ADHD/Germany | – | – |
| Control/Germany | – | – |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited respectively in Germany and Taiwan using the same standardized procedures according to the protocol. Children and adolescents with and without ADHD between the ages 10 to 14, with an IQ full score ≥ 80, will participate in this study. Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before enrolment. They are diagnosed with ADHD combined subtype and have no comorbid disorders. None of the controls are clinically diagnosed with any disorders and take any medication. Both samples should be matched according to the variables: gender, IQ, and socio-economic status (SES).
Key inclusion criteria (4 listed)
- Participants with ADHD have to meet the criteria of ICD-10 (WHO, 1991) before enrolment.
- Participants with ADHD are diagnosed with ADHD combined subtype.
- Ages range from 10 to 14 when we conduct the study.
- IQ full score ≥ 80.
Key exclusion criteria (1 listed)
- The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, Mental Retardation, or Pervasive Developmental Disorder. Moreover, the subjects will be excluded from the control group if have a history of the following condition as defined by DSM-IV: ADHD or ASD in addition to the above exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Sep 2021.
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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.
Susan Shur-Fen Gau, MD, PhD principal investigator
National Taiwan University Hospital & College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit/Hyperactivity Disorder, run by National Taiwan University 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 4 inclusion and 1 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 2 Sep 2021. 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.
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 2 Sep 2021.