UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neural correlates of deception in social context in children with Autism Spectrum Disorder
Title of the study (Brief title)	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	Ryuta Kawashima
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Division of Developmental Cognitive Neuroscience
Address	4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-8457
Email	ryuta.kawashima.a6@tohoku.ac.jp

Public contact
Name of contact person	Susumu Yokota
Organization	Kyushu University
Division name	Faculty of Arts and Science
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
Email	yokota@artsci.kyuhu-u.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020211