Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433145
• Other study ID #: 201405086RINB
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2015
• Last updated: April 29, 2015
• Start date: October 2014
• Est. completion date: August 2017

Study information

• Verified date: April 2015
• Source: National Taiwan University Hospital
• Contact: Susan Shur-Fen Gau, MD, PhD
• Phone: 02-23123456
• Email: gaushufe[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 5 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The final balloon numbers and eaction time in delay aversion test which measured by the e-prime program on the laptop		up to 3 years	Yes
Primary	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		up to 3 years	Yes
Secondary	The error rate and hit reaction time in the day-night stroop test which measured by the e-prime program on the laptop		up to 3 years	Yes