UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017428 |
|---|---|
| Receipt number | R000020211 |
| Scientific Title | Neural correlates of deception in social context in children with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2017/05/07 17:29:52 |
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Basic information
Public title
Neural correlates of deception in social context in children with Autism Spectrum Disorder
Acronym
Neural correlates of deception in children with Autism Spectrum disorder
Scientific Title
Neural correlates of deception in social context in children with Autism Spectrum Disorder
Scientific Title:Acronym
Neural correlates of deception in children with Autism Spectrum disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural correlates of deceptive behavior in social context in children with Autism Spectrum Disorder.
Basic objectives2
Others
Basic objectives -Others
To reveal specific brain region related deceptive behavior in children with Autism Spectrum Disorder with functional MRI technique.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Task performance and functional brain image.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Children with Autism Spectrum Disorder.
Interventions/Control_2
Typical developing children.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients
1) Children who were diagnosed as autism spectrum disorder based on DSM-IV-TR or V, and ADI-R.
2) Children who do not have any severe neuropsychiatric disorders and physical illness.
3) Children whose IQs are avobe 70, and who can give informed assent.
Typical control
1) Children who do not have neuropsychiatric disorders and physical ilness.
2) Children whose IQs are avobe 70, and who can give infromed assent.
Key exclusion criteria
Children who has diagnoses as neuropsychiatric disorder and intellectual disorder and who do not have ability to assent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Division of Developmental Cognitive Neuroscience
Zip code
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-8457
ryuta.kawashima.a6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Susumu Yokota |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
Address
744 Motooka, Nishi ku, Fukuoka, Japan
TEL
092-802-6026
Homepage URL
http://www.idac.tohoku.ac.jp/ja/activities/info/news/150428.pdf
yokota@artsci.kyuhu-u.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020211
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
