UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051738 |
|---|---|
| Receipt number | R000059052 |
| Scientific Title | An observational study to verify the reliability and validity of the Japanese version of the M-CHAT-R/F in Japanese infants |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/07/28 15:15:08 |
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Basic information
Public title
An observational study to verify the reliability and validity of the Japanese version of the M-CHAT-R/F in Japanese infants
Acronym
Reliability and validity verification study of the Japanese version of M-CHAT-R/F
Scientific Title
An observational study to verify the reliability and validity of the Japanese version of the M-CHAT-R/F in Japanese infants
Scientific Title:Acronym
Reliability and validity verification study of the Japanese version of M-CHAT-R/F
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the reliability and validity of the Japanese version of the M-CHAT-R/F screening instrument for autism spectrum disorder (ASD) in Japanese infants.
Basic objectives2
Others
Basic objectives -Others
Reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity:
Area under the curve (AUC of ROC) of ASD diagnoses assessed based on the M-CHAT-R/F Japanese version against the presence or absence of autism spectrum disorder/autism spectrum disorder (ASD) as assessed by the ADOS-2, ADI-R or PARS-TR
- Agreement (Cohen's Kappa coefficient) between the presence or absence of ASD assessed by a team of experts skilled in ASD clinical practice based on the ADOS-2 and the ADI-R or PARS-TR in accordance with the DSM-5 and ASD diagnostic results assessed in accordance with the M-CHAT-R/F Japanese version.
Agreement (Cohen's Kappa coefficient) between the Japanese version of the Infant and Toddler Developmental Screening Questionnaire (ASQ-3) and ASD diagnostic results assessed based on the Japanese version of the M-CHAT-R/F.
Reliability:Reliability of the M-CHAT-R/F Japanese version (Cronbach's alpha coefficient)
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
| 16 | months-old | <= |
Age-upper limit
| 30 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. the child must be between 16 and 30 months of age at the time consent is obtained
2. the primary caregiver and the child must be living together at the time consent is obtained
3. the parent or guardian of the subject child agrees with the content of the study and gives written consent for participation in the study
4. the parent/guardian of the subject child is able to understand the Japanese language described in the consent document and the questionnaire.
Key exclusion criteria
1. the parent or guardian of the research subject child is under 18 years of age
2. parents or guardians of the research subject child who require a surrogate guardian; 3. the research subject child has already been diagnosed with ASD
3. the research subject child has already been diagnosed with ASD
4. the research subject child has a severe mental or physical disability
5. Other subjects who are deemed inappropriate to participate in this study by the Principal Investigator or a Research Supervisor.
Target sample size
51
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 | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following will be conducted in this study
1. the Japanese version of the M-CHAT R/F. Further follow-up questions will be asked of those who are at intermediate risk on the M-CHAT R.
2. new version of the K-type developmental test
ASQ-3 (Ages & Stages Questionnaires, Third Edition) Japanese version
ADOS-2 (Autism Diagnostic Observation Schedule Second Edition): To be administered by the principal investigator or collaborator who is a physician or psychologist. 5.
ADI-R or PARS-TR (Parent-interview ASD Rating Scale-Text Revision)
Management information
Registered date
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059052
