UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051739 |
|---|---|
| Receipt number | R000058290 |
| Scientific Title | An exploratory observational study of the reliability and validity of the Japanese version of the TASI in Japanese infants |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/07/28 15:17:04 |
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Basic information
Public title
An exploratory observational study of the reliability and validity of the Japanese version of the TASI in Japanese infants
Acronym
A study of the reliability and validity of the Japanese version of the TASI
Scientific Title
An exploratory observational study of the reliability and validity of the Japanese version of the TASI in Japanese infants
Scientific Title:Acronym
A study of the reliability and validity of the Japanese version of the TASI
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the reliability and validity of the Japanese version of the TASI, a 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 TASI 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 based on the DSM-5 and the ASD diagnosis assessed based on the TASI Japanese version by a team of experts skilled in ASD clinical practice based on the ADOS-2 and the ADI-R or PARS-TR.
Reliability: Reliability of the Japanese version of the TASI (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
| 1 | years-old | <= |
Age-upper limit
| 3 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. the child is between 1 and 3 years of age at the time consent is obtained
2. the father, mother, and the infant must be living together at the time consent is obtained
3. the parents or guardians of the subject child have agreed to the content of this study and have given their written consent to participate in the study
4. the 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 | 08 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, the following will be conducted
1. questions about children and their parents/guardians
2. the Japanese version of the TASI: through online interviews
3. the new version of the K-type developmental test
4. the ADOS-2 (Autism Diagnostic Observation Schedule Second Edition Autism Diagnostic Observation Test)
ADI-R or PARS-TR (Parent-interview ASD Rating Scale-Text Revision)
The principal investigator or research collaborator, who is a physician or psychologist, will administer 2 and 3.
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=R000058290
