UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035359 |
|---|---|
| Receipt number | 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 | 2022/08/10 13:09:18 |
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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
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Ota |
Organization
Saitama Medical University Hospital
Division name
Department of Psychiatry
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1282
toshiota@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | Takasugi |
Organization
Saitama Medical University Hospital
Division name
Department of Psychiatry
Zip code
340-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1282
Homepage URL
takasugi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
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
IRB
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
0492761354
hirb@saitama-med.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
| 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
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
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
