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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035359
Receipt No. R000040293
Scientific Title A study of emotion recognition impairment in autism spectrum disorder using a video clip of simulated counseling interview and POMS 2(Profile of Mood States Second Edition Adults Forms)
Date of disclosure of the study information 2019/01/07
Last modified on 2018/12/25

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Basic information
Public title A study of emotion recognition impairment in autism spectrum disorder using a video clip of simulated counseling interview and POMS 2(Profile of Mood States Second Edition Adults Forms)
Acronym A study of emotion recognition impairment in autism spectrum disorder using a video clip of simulated counseling interview and POMS 2(Profile of Mood States Second Edition Adults Forms)
Scientific Title A study of emotion recognition impairment in autism spectrum disorder using a video clip of simulated counseling interview and POMS 2(Profile of Mood States Second Edition Adults Forms)
Scientific Title:Acronym A study of emotion recognition impairment in autism spectrum disorder using a video clip of simulated counseling interview and POMS 2(Profile of Mood States Second Edition Adults Forms)
Region
Japan

Condition
Condition Autism spectrum disorder patients and healthy individuals
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate emotion recognition ability in patients with ASD
Basic objectives2 Others
Basic objectives -Others To analyze emotion subscales of POMS 2(Profile of Mood States Second Edition Adults Forms)
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The emotion subscales of POMS 2(Profile of Mood States Second Edition Adults Forms)
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 Prevention
Type of intervention
Other
Interventions/Control_1 After watching a video clip of a simulated interview, subjects are asked to fill in the POMS 2(Profile of Mood States Second Edition Adults Forms)and a short questionnaire with several items.
Interventions/Control_2 After watching a video clip of a simulated interview, subjects are asked to fill in the POMS 2(Profile of Mood States Second Edition Adults Forms)and a short questionnaire with several items.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASD group
Patients who had given a clinical diagnosis of ASD in Department of Psychiatry of the Saitama Medical University Hospital

Normal control subjects group
1)No diagnosis of ASD
2)Not a family member of a patient of ASD
Key exclusion criteria Subjects who are judged as unsuitable for this study
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshio Ota
Organization Saitama Medical University Hospital
Division name Department of Psychiatry
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1282
Email toshiota@saitama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Ayaka Takasugi
Organization Saitama Medical University Hospital
Division name Department of Psychiatry
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1282
Homepage URL
Email takasugi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

Funding Source
Organization Saitama Medical University Hospital
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
2019 Year 01 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 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
2018 Year 12 Month 25 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040293

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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