Executive Functions and Self-Regulation Among Children With and Without ADHD in Germany and Taiwan

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01677832
First received: August 30, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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.


Condition
Attention-Deficit/Hyperactivity Disorder

Study Type: Observational
Official Title: Neuronal Correlates of Executive Functions and Self-Regulation Among Children and Adolescents With and Without ADHD in Germany and Taiwan

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Groups/Cohorts
ADHD/Taiwan
Control/Taiwan
ADHD/Germany
Control/Germany

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.

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677832

Contacts
Contact: Susan Shur-Fen Gau, MD, PhD 886-2-23123456 ext 66802 gaushufe@ntu.edu.tw

Locations
Taiwan
National Taiwan Univeristy Hospital Recruiting
Taipei, Taiwan
Contact: Susan Shur-Fen Gau, MD, PhD    886-2-23123456 ext 66802    gaushufe@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Susan Shur-Fen Gau, MD, PhD National Taiwan University Hospital & College of Medicine
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Susan Shur-Fen Gau
ClinicalTrials.gov Identifier: NCT01677832     History of Changes
Other Study ID Numbers: 201201062RIB
Study First Received: August 30, 2012
Last Updated: August 30, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014