NCT01677832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

August 30, 2012

Last Update Submit

September 1, 2021

Conditions

Study Arms (4)

ADHD/Taiwan

Control/Taiwan

ADHD/Germany

Control/Germany

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Susan Shur-Fen Gau

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 3, 2012

Study Start

January 1, 2012

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations