UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056154 |
|---|---|
| Receipt number | R000064152 |
| Scientific Title | Kit for Assessment of Time Processing Ability: Test-retest reliability and inter-rater reliability of the KaTid-Child Japan - Pilot study on Japanese children |
| Date of disclosure of the study information | 2024/11/14 |
| Last modified on | 2024/11/14 11:45:33 |
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Basic information
Public title
Kit for Assessment of Time Processing Ability: Test-retest reliability and inter-rater reliability of the KaTid-Child Japan - Pilot study on Japanese children
Acronym
KaTid-Child Japan Reliability Study
Scientific Title
Kit for Assessment of Time Processing Ability: Test-retest reliability and inter-rater reliability of the KaTid-Child Japan - Pilot study on Japanese children
Scientific Title:Acronym
KaTid-Child Japan Reliability Study
Region
| Japan |
Condition
Condition
This study does not target any specific condition.
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to validate the Japanese version of the KaTid-Child assessment tool by examining its test-retest reliability, inter-rater reliability, and by comparing Japanese children's Time Processing Ability (TPA) scores with the developmental age bands of the original Swedish KaTid-Child.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes of this study are the verification of test-retest reliability and inter-rater reliability of the Japanese version of the KaTid-Child assessment tool, as well as the evaluation of Japanese children's Time Processing Ability (TPA) scores in comparison with the developmental age bands of the original Swedish KaTid-Child.
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
| 5 | years-old | <= |
Age-upper limit
| 11 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study included children aged 5 to 10 years who did not have a diagnosis of ASD (Autism Spectrum Disorder), ADHD (Attention Deficit Hyperactivity Disorder), or DCD (Developmental Coordination Disorder) as inclusion criteria.
Key exclusion criteria
The exclusion criteria included children who were unable to adapt to the measurement schedules or who had been diagnosed with autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), or developmental coordination disorder (DCD).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tasaka |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services Department of Occupational Therapy
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-973-4125
tasaka-shota@spu.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tasaka |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services Department of Occupational Therapy
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
TEL
048-973-4125
Homepage URL
tasaka-shota@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Shota Tasaka
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI) from the Japan Society for the Promotion of Science (JSPS)
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
Saitama Prefectural University
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan
Tel
048-973-4125
somu@spu.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
| 2024 | Year | 11 | Month | 14 | 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
12
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
| 2020 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the event that the subject child expresses fatigue or a lack of physical condition during the measurement, a break or suspension will be permitted at the subject's discretion. Furthermore, consent to participate in the research can be revoked at any time.
No significant alterations have been made to the study protocol, which is currently in progress.
The results of this study are scheduled for presentation at academic conferences or publication in academic journals in the future.
The measurements of the 12 participants, conducted in accordance with the aforementioned protocol, have been completed.
This research is intended to lay the foundation for future studies in the field.
Information on Funding Sources and Conflicts of Interest:
No conflicts of interest are associated with this research, which is funded by a Grant-in-Aid for Scientific Research (Kakenhi).
Management information
Registered date
| 2024 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064152
