UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053588 |
|---|---|
| Receipt number | R000061150 |
| Scientific Title | Investigation of the Current Situation and Analysis of the Characteristics of Highly Sensitive Children among Truants |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2024/02/09 20:51:16 |
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Basic information
Public title
Characteristic Analysis of Highly Sensitive Children
Acronym
Characteristic Analysis of Highly Sensitive Children
Scientific Title
Investigation of the Current Situation and Analysis of the Characteristics of Highly Sensitive Children among Truants
Scientific Title:Acronym
Characteristic Analysis of Highly Sensitive Children
Region
| Japan |
Condition
Condition
highly sensitive children
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the characteristics of children with high sensory processing sensitivity.
Basic objectives2
Others
Basic objectives -Others
Examines sensitivity, stress, interpersonal sensitivity, personality and neurodevelopmental traits in highly sensitive children.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Highly Sensitive Child Scale for Childhood(HSCS-C); Japanese Version of the Highly Sensitive Child Scale for Adolescence(HSCS-A); Childrens Stress Response(CSR); Short Forms of the Children's Interpersonal Sensitivity Measure; Five Factor Personality Inventory for Children(FFPC); Five Factor Personality Inventory; Japanese Version of Autism-spectrum Quotient for children(AQ); ADHD Rating Scale-IV(ADHD-RS-IV)Japanese Version; Developmental Coordination Disorder Questionnaire(DCDQ)Japanese Version; Motor resonance task data
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
| 9 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children not attending school
Key exclusion criteria
None in particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Emiko |
| Middle name | |
| Last name | Takata |
Organization
Kio University
Division name
Faculty of Education
Zip code
635-0832
Address
4-2-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
e.takata@kio.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nobusako |
Organization
Kio University
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2-2, Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara
TEL
0745-54-1601
Homepage URL
s.nobusako@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University Ethics Committee
Address
4-2-2, Umaminaka, Koryo-cho, Kitakaturagi-gun, Nara, Japan
Tel
0745541601
s.nobusako@kio.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 | 02 | Month | 10 | 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
| 2024 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Examines sensitivity, stress, interpersonal sensitivity, personality, neurodevelopmental traits(ASD, ADHD, DCD) and motor resonance abilities in highly sensitive children and explores their relationships.
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061150
| Research Plan | |
|---|---|
| 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 |
