UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047297 |
|---|---|
| Receipt number | R000053889 |
| Scientific Title | Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/03/27 10:37:17 |
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Basic information
Public title
Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Acronym
Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Scientific Title
Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Scientific Title:Acronym
Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Region
| Japan |
Condition
Condition
developmental disorder
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
measure the effectiveness of psychological assistance on stress reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stress response scale for children
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
introduction of clay dialogues
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
an elementary school student who attends a day service after school
Key exclusion criteria
a child who is scheduled to leave school in the middle of a study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayaka |
| Middle name | |
| Last name | Furuichi |
Organization
International Graduate School of Health and Welfare
Division name
Medical Welfare Research Department clinical psychology major
Zip code
107-8402
Address
Akasaka 4-1-26 Minato Ward, Tokyo
TEL
03-5574-3900
21s4016@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ayaka |
| Middle name | |
| Last name | furichi |
Organization
International Graduate School of Health and Welfare
Division name
Medical Welfare Research Department clinical psychology major
Zip code
107-8402
Address
Akasaka 4-1-26 Minato Ward, Tokyo
TEL
03-5574-3900
Homepage URL
21s4016@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
Akasaka 4-1-26 Minato Ward, Tokyo
Tel
03-5574-3900
21s4016@g.iuhw.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
| 2022 | Year | 12 | Month | 01 | 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
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053889
