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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024770
Receipt No. R000028495
Scientific Title Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders
Date of disclosure of the study information 2016/11/08
Last modified on 2016/11/08

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Basic information
Public title Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders
Acronym Visual Attention for Social Information and Salivary Oxytocin Levels in ASD
Scientific Title Relationship between Visual Attention for Social Information and Salivary Oxytocin Levels in Autism Spectrum Disorders
Scientific Title:Acronym Visual Attention for Social Information and Salivary Oxytocin Levels in ASD
Region
Japan

Condition
Condition Autism Spectrum Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationships between visual attention for social information and oxytocin (OT) levels in autism spectrum disorder (ASD) and typical development (TD).
Basic objectives2 Others
Basic objectives -Others To investigate the relationships between visual attention for social information and oxytocin (OT) levels in autism spectrum disorder (ASD) and typical development (TD).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual attention for social information mesured by GazeFinder
Key secondary outcomes OT
WAIS-3
PHQ-9
GAD-7
SDISS
EQ-5D
BDI
STAI
ADOS
PARS
AQ
SRS-2
RAADS-14
ASRS
CAARS
Vineland-II
SES
Edinburgh inventory
Neuropsychological test
NIRS
Heart rate
SCL
WISC
DSRS-C
SCAS
CBCL
SDQ

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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Visual attention for the social information.
Interventions/Control_2 Visual attention for the social information.
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
0 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria ASD group
To meet the diagnostic criteria for ASD as a primary diagnostic.
TD group
Individuals who do not meet the criteria for ASD nor other psychiatric disorders.
Key exclusion criteria Individuals who have histories of substance abuse, active sucidality, severe mental and physical condition.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Hirano
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 0432262975
Email hirano@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aki Tsuchiyagaito
Organization Chiba University
Division name Research Center for Child Mental Development
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 0432262975
Homepage URL
Email a-tsuchiyagaito@umin.ac.jp

Sponsor
Institute Research Center for Child Mental Development, Chiba University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 08 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 Enrolling by invitation
Date of protocol fixation
2015 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 17 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
2016 Year 11 Month 08 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028495

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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