Attention Deficit/Hyperactivity DisorderNCT02433145
Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children
An observational study of Attention Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Susan Shur-Fen Gau, MD, PhD, 02-23123456 ext. 66802, gaushufe@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- ADHD in preschoolers, neuropsychological functions, behavior inhibition, family function and parenting
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433145
- Sponsor's protocol ID
- 201405086RINB
- Status last verified
- Apr 2015
- First submitted
- 29 Apr 2015
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Association Between Neuropsychological Functions and ADHD Diagnosis and Comorbid Using Longitudinal Study in Preschool Children
- ClinicalTrials.gov ID
- NCT02433145
- Acronym / sponsor ID
- 201405086RINB
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- ADHD in preschoolers, neuropsychological functions, behavior inhibition, family function and parenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (10 listed)
- Control group
- ADHD high risk group
Key exclusion criteria (7 listed)
- Mental Retardation
- Schizophrenia, Schizoaffective Disorder
- Mood Disorders
- Organic Psychosis
- Learning Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Shur-Fen Gau, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Shur-Fen Gau, MD, PhD (02-23123456 ext. 66802, gaushufe@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.