UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051732 |
|---|---|
| Receipt number | R000058288 |
| Scientific Title | Research on a Diagnostic Support System Using Video Analysis for Children with Autism Spectrum Disorder |
| Date of disclosure of the study information | 2023/07/27 |
| Last modified on | 2023/07/27 21:11:26 |
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Basic information
Public title
Research on a Diagnostic Support System Using Video Analysis for Children with Autism Spectrum Disorder
Acronym
Research on a Diagnostic Support System Using Video Analysis for Children with Autism Spectrum Disorder
Scientific Title
Research on a Diagnostic Support System Using Video Analysis for Children with Autism Spectrum Disorder
Scientific Title:Acronym
Research on a Diagnostic Support System Using Video Analysis for Children with Autism Spectrum Disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the accuracy of a diagnostic support system based on video analysis that uses AI to automate the thought processes involved in making a diagnosis of a developmental disorder by comparing its accuracy to that of the ADOS/ADI-R (or PARS-TR).
Basic objectives2
Others
Basic objectives -Others
Accuracy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Reference Criteria
1) Diagnosis of ASD by ADOS and ADI-R or PARS-TR
The reference standard is the diagnosis of ASD by the ADOS and the ADI-R or the PARS-TR. When the results of either the ADOS or the ADI-R indicate ASD and the other indicates non-ASD, a psychiatrist or pediatrician who is board certified in the specialty will make a comprehensive diagnosis based on the Diagnostic Statistical Manual-5 (DSM-5), the diagnostic criteria of the American Psychiatric Association. Diagnostic Statistical Manual-5 (DSM-5). Note that the "diagnosis" in this study is a research diagnosis and not a medical clinical diagnosis.
(2) Index Test
Features by ASD Diagnostic Aids System
M-CHAT (under 3 years old) or SRS (over 3 years old) and features by ASD Diagnostic Aids System
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children whose developmental problems were identified at the 1.5 year and 3 year checkups and are being followed up afterwards.
Or, children whose parents are concerned about their development.
Key exclusion criteria
- Children with physical illnesses for which treatment is a priority
- Children whose parents/guardians are unable to take videos for analysis for some reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Tachibana |
Organization
National Center for Child Health and Development
Division name
Hospital
Zip code
157-8535
Address
2-10-1 Okura Setagaya-ku Tokyo
TEL
03-5494-7120
tachibana-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Tachibana |
Organization
National Center for Child Health and Development
Division name
Hospital
Zip code
157-8535
Address
2-10-1 Okura Setagaya-ku Tokyo
TEL
03-5494-7120
Homepage URL
tachibana-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Center for Child Health and Development Ethics Review Committee Secretariat
Address
2-10-1 Okura Setagaya-ku Tokyo
Tel
03-5494-7243
rinri@ncchd.go.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
| 2023 | Year | 07 | Month | 27 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The principal investigator or co-investigator, who is a physician or psychologist, will conduct behavioral observations using the ADOS and developmental history taking using the ADI-R or PARS-TR. In addition, the principal investigator, co-investigators, or collaborators will explain to the subject's family how to take the video. In addition, the parents/guardians of the research subjects will answer the SRS-2 (for children aged 3 years and older), the M-CHAT (for children aged 18 months to less than 36 months), and the CBCL, and will take videos of parent-child play scenes at home and at the Japan TheraPlay Association using their smartphones. The CBCL is a program for parents and their children to record videos of their own playtime.
Management information
Registered date
| 2023 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058288
| Research Plan | |
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| 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 |
