UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060833 |
|---|---|
| Receipt number | R000069599 |
| Scientific Title | Development of a novel evaluation framework for time processing ability in children aged 5 to 10 years |
| Date of disclosure of the study information | 2026/03/05 |
| Last modified on | 2026/03/05 11:19:08 |
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Basic information
Public title
Development of a novel evaluation framework for time processing ability in children aged 5 to 10 years
Acronym
Development study of the Japanese version of KaTid-Child (KaTid-C-J)
Scientific Title
Development of a novel evaluation framework for time processing ability in children aged 5 to 10 years
Scientific Title:Acronym
Development of KaTid-C-J
Region
| Japan |
Condition
Condition
Time processing ability in children (typically developing children)
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a new standardized evaluation tool, the Japanese version of KaTid-Child (KaTid-C-J), for quantitatively assessing Time Processing Ability (TPA) across developmental stages, adapted to the cultural and social environment of Japan. Specifically, the aim is twofold: first, to design an original tool reflecting Japanese lifestyle and cultural characteristics; and second, to calculate standard TPA values for typically developing children aged 5 to 10 years. The Swedish KaTid-Child was referenced in the design of the original tool. The establishment of these standard values will serve as a foundational framework for comprehensively supporting the development of children's time concepts, facilitating problem-solving in time perception, time orientation, and time management, and promoting social participation.
Basic objectives2
Others
Basic objectives -Others
Development and standardization of an assessment tool
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation scores of Time Processing Ability (TPA) will be measured using the Japanese version of KaTid-Child (KaTid-Child-Japan: KaTid-C-J). The assessment is designed to be completed within a time frame of approximately 45 minutes for a single session.
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
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study is open to children between the ages of 5 and 10 years old (under 11 years old) whose guardians have provided consent to participate.
Key exclusion criteria
1. Children whose measurement date and location cannot be scheduled.
2. Children who cancel on the day of measurement due to health issues or other reasons and cannot be rescheduled.
3. Children diagnosed with Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Developmental Coordination Disorder (DCD), or other related conditions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tasaka |
Organization
Saitama Prefectural University Graduate School
Division name
Graduate School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya, Saitama
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 Graduate School
Division name
Graduate School of Health and Social Services
Zip code
343-8540
Address
820 Sannomiya, Koshigaya, Saitama
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
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University Research Ethics Committee
Address
820 Sannomiya, Koshigaya, Saitama
Tel
048-973-4125
tasaka-shota@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
| 2026 | Year | 03 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 02 | Month | 29 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This cross-sectional observational study involves typically developing children aged 5 to 10 years. Participants will undergo a single assessment (with an approximate duration of 45 minutes) using the Japanese version of the KaTid-Child (KaTid-C-J) scale. The provision of new treatments or interventions is not a component of the present protocol. The assessment results will be used to calculate standard values for Time Processing Ability.
Management information
Registered date
| 2026 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069599
