NCT02433145

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

April 29, 2015

Last Update Submit

April 29, 2015

Conditions

Keywords

ADHD in preschoolersneuropsychological functionsbehavior inhibitionfamily function and parenting

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • 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

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • Mental Retardation
  • Schizophrenia, Schizoaffective Disorder
  • Mood Disorders
  • Organic Psychosis
  • Learning Disorder
  • Pervasive Developmental Disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Shur-Fen Gau, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

October 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 4, 2015

Record last verified: 2015-04

Locations