Attention Deficit/Hyperactivity DisorderNCT02017483
Explore the Association Between the Emotion Recognition and the Attention Processing Under the Emotional Stimuli in ADHD
An observational study of Attention Deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lots of studies suggest that children with ADHD have deficits in facial emotion recognition, especially for the negative emotion. But there were arguments for this deficit is a secondary problem due to the general attention impairment in ADHD, or a specific social cognitive processing to ADHD. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jan 2016
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: We will recruit 100 children and adolescent with ADHD and 100 typical controls.
Who may be able to join
- Control group
- The subjects without ADHD.
- Ages range from 8 to 16
- Full scale IQ ≥ 80
- The subjects who and whose parents consent to this study.
- ADHD group
Show all 10Show fewer
- Patients who have clinically diagnosis of DSM-IV ADHD confirmed by the K-SADS-E.
- Ages range from 8 to 16
- 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 Univeristy Hospital
Taipei
Susan Shur-Fen Gau, MD, PhD, 886-2-23123456 ext. 66802, gaushufe@ntu.edu.tw
About this study
Lots of studies suggest that children with ADHD have deficits in facial emotion recognition, especially for the negative emotion. But there were arguments for this deficit is a secondary problem due to the general attention impairment in ADHD, or a specific social cognitive processing to ADHD. The objectives of this study are to investigate that association between the deficits in facial emotion recognition and the emotional attention processing in ADHD. In this study, the investigators use the emotion attentional bias and emotional go / no go paradigm to answer this question.
Read the detailed description
The sample will consist of 100 children and adolescent with ADHD and 100 typical controls, ages 8-16. The ADHD group inclusion criteria are patients who have clinically diagnosis of DSM-IV ADHD confirmed by the K-SADS-E, and have IQ > 80; and whose parents consent to this study.
The measurements will be included:
- Diagnostic assessment tools:
- Chinese version of Kiddie-Schedule for Affective Disorders and Schizophrenia-Epidemiology version.
- Conners' Parent/Teacher Rating Scale- Revised: Short Form, CPRS-R:S/CTRS-R:S.
- Swanson, Nolan, and Pelham, Version Ⅳ（SNAP-Ⅳ）Rating Scale - Parent/ Teacher Form.
- Emotion assessment tools:
- Facial emotion recognition task.
- Emotional attentional bias task.
- Emotional Go/ No Go task.
- Cognitive assessment tool:
- Wechsler Intelligence Scale for Children-Fourth Edition Chinese Version.
This study could offer the suggestion for the further intervention of social function in ADHD.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- ADHD,, emotion recognition, attention
- 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 in facial emotion judgements on computerized task
Investigator used the e-prime program to assess the error rate in facial emotion judgements. Participants need to judge the emotion of the face stimuli presented on the laptop.
Measured: up to 2 years
Secondary outcomes (1)
The reaction time of attentional bias for pairs of face stimuli(happy/neutral or angry/neutral faces) on dot-prob task
Investigator presented pairs of face stimuli with emotional and neutral expressions and probed the allocation of attention to these stimuli for presentation times of 150 and 500 ms to assess the reaction time of attentional bias. Participants need to press the dot after the prob.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017483
- Sponsor's protocol ID
- 201211008RIB
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Association Between the Emotion Recognition and the Attention Processing Under the Emotional Stimuli in ADHD
- ClinicalTrials.gov ID
- NCT02017483
- Acronym / sponsor ID
- 201211008RIB
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- ADHD,, emotion recognition, attention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 20 Dec 2013 (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.
Lots of studies suggest that children with ADHD have deficits in facial emotion recognition, especially for the negative emotion. But there were arguments for this deficit is a secondary problem due to the general attention impairment in ADHD, or a specific social cognitive processing to ADHD. The objectives of this study are to investigate that association between the deficits in facial emotion recognition and the emotional attention processing in ADHD. In this study, the investigators use the emotion attentional bias and emotional go / no go paradigm to answer this question.
Detailed description
The sample will consist of 100 children and adolescent with ADHD and 100 typical controls, ages 8-16. The ADHD group inclusion criteria are patients who have clinically diagnosis of DSM-IV ADHD confirmed by the K-SADS-E, and have IQ > 80; and whose parents consent to this study.
The measurements will be included:
- Diagnostic assessment tools:
- Chinese version of Kiddie-Schedule for Affective Disorders and Schizophrenia-Epidemiology version.
- Conners' Parent/Teacher Rating Scale- Revised: Short Form, CPRS-R:S/CTRS-R:S.
- Swanson, Nolan, and Pelham, Version Ⅳ（SNAP-Ⅳ）Rating Scale - Parent/ Teacher Form.
- Emotion assessment tools:
- Facial emotion recognition task.
- Emotional attentional bias task.
- Emotional Go/ No Go task.
- Cognitive assessment tool:
- Wechsler Intelligence Scale for Children-Fourth Edition Chinese Version.
This study could offer the suggestion for the further intervention of social function in ADHD.
Study design
- Observational model
- Case-control
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We will recruit 100 children and adolescent with ADHD and 100 typical controls.
Key inclusion criteria (10 listed)
- Control group
- ADHD 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 in facial emotion judgements on computerized task
Time frame: up to 2 years
Investigator used the e-prime program to assess the error rate in facial emotion judgements. Participants need to judge the emotion of the face stimuli presented on the laptop.
1 secondary outcome
The reaction time of attentional bias for pairs of face stimuli(happy/neutral or angry/neutral faces) on dot-prob task
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
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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 20 Dec 2013. 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 (886-2-23123456 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 in facial emotion judgements on computerized task (time frame: up to 2 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 20 Dec 2013.