UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049182 |
|---|---|
| Receipt number | R000056019 |
| Scientific Title | A feasibility study of the "Journey of the Brave" e-Learning Edition, a preventive education program on anxiety based on cognitive behavior therapy for Japanese Primary School Children |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2023/10/12 10:07:17 |
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Basic information
Public title
A feasibility study of the "Journey of the Brave" e-Learning Edition, a preventive education program on anxiety based on cognitive behavior therapy for Japanese Primary School Children
Acronym
A feasibility study of the "JOB" e-Learning Edition, a preventive education program on anxiety based on cognitive behavior therapy for Japanese Primary School Children
Scientific Title
A feasibility study of the "Journey of the Brave" e-Learning Edition, a preventive education program on anxiety based on cognitive behavior therapy for Japanese Primary School Children
Scientific Title:Acronym
A feasibility study of the "JOB" e-Learning Edition, a preventive education program on anxiety based on cognitive behavior therapy for Japanese Primary School Children
Region
| Japan |
Condition
Condition
Elementary school children aged 10-12
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and acceptability of the "Journey of the Brave" e-Learning Edition
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dropout rate
Key secondary outcomes
Spence Children's Anxiety Scale, Emotion-Regulation Skills Questionnaire, Strength and Difficulties Questionnaire, satisfaction
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
CBT-based universal anxiety prevention program
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
| 10 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children attending the elementary school in grade 5-6 and their parent
Key exclusion criteria
Children not attending the school
Children diagnosed with mental disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Ohashi |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
Homepage URL
shoichi.o@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI grant from the Japan Society for the Promotion of Science
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
Chiba University
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
043-226-2975
chibarccmd@ML.chiba-u.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 | 10 | Month | 11 | 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
90
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056019
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
