UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031775 |
|---|---|
| Receipt number | R000036274 |
| Scientific Title | A study of facial emotion recognition ability and attentional characteristics in adults with developmental disorders |
| Date of disclosure of the study information | 2018/03/17 |
| Last modified on | 2019/10/29 10:08:39 |
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Basic information
Public title
A study of facial emotion recognition ability and attentional characteristics in adults with developmental disorders
Acronym
A study of facial emotion recognition ability and attentional characteristics in developmental disorders
Scientific Title
A study of facial emotion recognition ability and attentional characteristics in adults with developmental disorders
Scientific Title:Acronym
A study of facial emotion recognition ability and attentional characteristics in developmental disorders
Region
| Japan |
Condition
Condition
Individuals with autism spectrum disorder, Individuals with attention deficits hyperactivity disorder, and healthy adults
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate facial emotion recognition ability and attentional characteristics in individuals with ASD, those with ADHD, and healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral tests
Key secondary outcomes
Questionnaires
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
3
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Behavioral tests
Interventions/Control_2
Behavioral tests
Interventions/Control_3
Behavioral tests
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ASD group
1) Subjects who had received a clinical diagnosis of ASD in outpatient units of the Showa University Karasuyama Hospital.
2) Aged 20-49 years-old, male and female
3) No serious comorbid psychiatric disorders or medical illness.
4) Capability of informed consent
ADHD group
1) Subjects who had received a clinical diagnosis of ADHD in outpatient units of the Showa University Karasuyama Hospital.
2) Aged 20-49 years-old, male and female
3) No serious comorbid psychiatric disorders or medical illness.
4) Capability of informed consent
Healthy group
1) Aged 20-49 years-old, male and female
2) No serious psychiatric disorders or medical illness.
3) Capability of informed consent
Key exclusion criteria
Subjects who are judged as unsuitable for participation in this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Itahashi |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
Address
6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL
03-5315-9357
ita3@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Itahashi |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
Address
6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL
03-5315-9357
Homepage URL
ita3@med.showa-u.ac.jp
Sponsor or person
Institute
Medical Institute of Developmental Disabilities Research, Showa university
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 03 | Month | 17 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036274
