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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02017483
Other study ID # 201211008RIB
Secondary ID
Status Recruiting
Phase N/A
First received December 4, 2013
Last updated December 16, 2013
Start date July 2013
Est. completion date January 2016

Study information

Verified date December 2013
Source National Taiwan University Hospital
Contact Susan Shur-Fen Gau, MD, PhD
Phone 886-2-23123456
Email gaushufe@ntu.edu.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical 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. 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.


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:

1. 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.

2. Emotion assessment tools:

- Facial emotion recognition task.

- Emotional attentional bias task.

- Emotional Go/ No Go task.

3. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 16 Years
Eligibility Inclusion Criteria:

1. 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.

2. ADHD group

- 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.

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


Related Conditions & MeSH terms

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

Locations

Country Name City State
Taiwan National Taiwan Univeristy Hospital Taipei

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other The attentional inhibition control(omission errors and commission errors) in emotional go/no go task Investigator used go/ no go task to assess participants' omission errors and commission errors, participants just need to press the keyboard and the number of errors were recorded. up to 2 years Yes
Primary 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. up to 2 years Yes
Secondary 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. up to 2 years Yes
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