UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039706
Receipt number 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 09:28:53

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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 or person

Institute

Nara Medical University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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