- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02433145
Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children
April 29, 2015 updated by: National Taiwan University Hospital
The current study using the longitudinal study in preschool children to exam three study issues: 1) using the neuropsychological functions (ie.
Behavioral inhibition, delay aversion, the variability of reaction time) among the preschool children predict the ADHD diagnosis and behavior symptoms in 1.5 years later.
2) using the behavior inhibition, delay aversion and the variability of reaction time (using the parameter among Gaussian distribution and ex-Gaussian distribution) explore the association between attention and motor inhibition problems.
3) explore the transaction effect between the neuropsychological functions and family function and parenting to predict ADHD comorbidity with oppositional defiant disorder.4)
explore the association between the internalizing/ externalizing problems of ADHD and temperament.
The current study has opportunity to describe and to answer the complicated problems for heterogeneous neuropsychological deficits in ADHD, and to elucidate the core issues for ADHD have comorbid with ODD.
The most important contribution is to offer the empirical evidence to make a clean suggestion in ADHD diagnosis and intervention in preschool age.
Study Overview
Status
Unknown
Conditions
Detailed Description
The current study would follow the same participants for 1.5 years, time 1 is around 4-5 years old, and time 2 is around 6-7 years old.
Participants:
- 100 typical developmental control
- 120 ADHD high risk preschool children at time 1
The diagnosis at time 2 to have three groups in this study:
- ADHD persistent
- ADHD remission
- typical developmental control
The measurements were included
- the different neuropsychological test (ie. behavioral inhibition, delay aversion, and vigilance task)
- the ADHD behavioral rating scales and diagnosis interview
- the scaling for family function and parenting
- intellectual assessment
This study could offer the suggestion for the further intervention in ADHD.
Study Type
Observational
Enrollment (Anticipated)
220
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
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Susan Shur-Fen Gau, MD, PhD
- Phone Number: 66802 02-23123456
- Email: gaushufe@ntu.edu.tw
-
-
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
4 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We will recruit 100 typical developmental control and 120 ADHD high risk preschool children at time 1, and we using the diagnosis at time 2 to have three groups in this study (ADHD persistent, ADHD remission and typical developmental control).
Description
Inclusion Criteria:
Control group
- The subjects without ADHD.
- Ages range from 4 to 5
- Full scale IQ ≥ 80
- The subjects who and whose parents consent to this study.
ADHD high risk group
- Patients who have clinically diagnosis of DSM-IV ADHD confirmed by the Psychiatrists or have the risk of becoming ADHD confirmed by the ADHD behavioral rating scales.
- Ages range from 4 to 5
- Full scale IQ ≥ 80
- Patients who and whose parents consent to this study.
Exclusion Criteria:
- Mental Retardation
- Schizophrenia, Schizoaffective Disorder
- Mood Disorders
- Organic Psychosis
- Learning Disorder
- Pervasive Developmental Disorder
- The subjects of control group if have a history of the following condition as defined by DSM-IV: ADHD in addition to the above exclusion criteria will be excluded.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The error rate and hit reaction time in the judgements on color flanker response inhibition test which measured by the e-prime program on the laptop
Time Frame: up to 3 years
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The error rate and hit reaction time in the day-night stroop test which measured by the e-prime program on the laptop
Time Frame: up to 3 years
|
up to 3 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The final balloon numbers and eaction time in delay aversion test which measured by the e-prime program on the laptop
Time Frame: up to 3 years
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan Shur-Fen Gau, MD, PhD, National Taiwan University Hospital
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, 2014
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
April 29, 2015
First Submitted That Met QC Criteria
April 29, 2015
First Posted (Estimate)
May 4, 2015
Study Record Updates
Last Update Posted (Estimate)
May 4, 2015
Last Update Submitted That Met QC Criteria
April 29, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201405086RINB
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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