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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039706
Receipt No. R000043895
Scientific Title Recording communication data of autism spectrum disorder and schizophrenia
Date of disclosure of the study information 2020/03/05
Last modified on 2020/03/05

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Basic information
Public title Recording communication data of autism spectrum disorder and schizophrenia
Acronym Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title Recording communication data of autism spectrum disorder and schizophrenia
Scientific Title:Acronym Recording communication data of autism spectrum disorder and schizophrenia
Region
Japan Europe

Condition
Condition autism spectrum disorder and schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Social skills are the ability to manage verbal and non-verbal behavior during a conversation. People who have difficulty in interacting with others struggle to properly manage their social behavior and interpret them. Social Skills Training is a well-founded method developed to train social interaction. In this study, we will collect data on how the subject and the trainer are conducting individual SST. Analyzing the verbal and non-verbal social skills of the subject and trainer from the recorded data of autism spectrum disorder and schizophrenia. The purpose of this study is to develop a system that can train social skills using virtual agents.
Basic objectives2 Others
Basic objectives -Others Evaluate verbal response dialogue patterns, non-verbal timing, intentions, phonemes, facial expressions, gestures
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Verbal response dialogue pattern, non-verbal timing, intention, phoneme, facial expression, gesture
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
6 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Autism spectrum disease between 6 and under 16
Autism spectrum disorder and schizophrenia between 20 and under 50
Key exclusion criteria intellectual disabilities, drug and alcohol abuse, personality disorders, or brain disorder
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email yasumatsuda319@hotmail.com

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email yasumatsuda319@hotmail.com

Sponsor
Institute Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Heartland Shigi
Nara Institute of Science and Technology
Centre national de la recherche scientifique
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University School of Medicine
Address 840 Shijo-cho, Kashihara, Nara
Tel 0744-22-3051
Email smuraka@naramed-u.ac.jp

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
2020 Year 03 Month 05 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
2019 Year 12 Month 18 Day
Date of IRB
2019 Year 12 Month 18 Day
Anticipated trial start date
2020 Year 03 Month 05 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We aim to build a computer dialogue system that reflects SST.

Management information
Registered date
2020 Year 03 Month 05 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043895

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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