UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057115 |
|---|---|
| Receipt number | R000065273 |
| Scientific Title | A pilot study of the e-learning version of the "Journey of the Brave:" A universal anxiety-prevention program based on cognitive behavioral therapy, in the school setting |
| Date of disclosure of the study information | 2025/02/21 |
| Last modified on | 2026/07/07 10:35:09 |
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Basic information
Public title
A pilot study of the e-learning version of the "Journey of the Brave:" A universal anxiety-prevention program based on cognitive behavioral therapy, in the school setting
Acronym
A pilot study of the e-learning version of the "Journey of the Brave:" A universal anxiety-prevention program based on cognitive behavioral therapy, in the school setting
Scientific Title
A pilot study of the e-learning version of the "Journey of the Brave:" A universal anxiety-prevention program based on cognitive behavioral therapy, in the school setting
Scientific Title:Acronym
A pilot study of the e-learning version of the "Journey of the Brave:" A universal anxiety-prevention program based on cognitive behavioral therapy, in the school setting
Region
| Japan |
Condition
Condition
Elementary school students aged 10-12
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the "Journey of the Brave" e-learning in reducing anxiety in school environments, its feasibility, and any issues.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Spence Children's Anxiety Scale
Key secondary outcomes
learning logs and satisfaction questionnaires
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
| Other |
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
Students attending the elementary school in grade 5-6
Key exclusion criteria
Children attending special support classes
Target sample size
200
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
Other
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
| 2025 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s13034-025-00956-8
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s13034-025-00956-8
Number of participants that the trial has enrolled
197
Results
The mean SCAS score decreased significantly from pre-intervention to 3 months after the end of the intervention (follow-up). On the other hand, it was found that gender and school differences affected changes in anxiety scores.
Results date posted
| 2025 | Year | 02 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 18 | Day |
Baseline Characteristics
The participants consisted of 204 elementary school students aged 10 to 12 enrolled at two elementary schools in Chiba Prefecture. Since this was a universal intervention aimed at preventing anxiety and targeted students in regular classrooms, children enrolled in special education classes who were receiving individualized educational support and instruction were excluded. On the other hand, students enrolled in regular classrooms were included in the study even if they had a history of school refusal, mental health issues, or a possible developmental disorder, provided they were attending class as usual.
Participant flow
We recruited schools to participate in the study through school boards that had previously implemented the in-person version of "The Journey of the Brave" and through participants in teacher training workshops. A total of 204 students from two schools registered; however, three students were absent from class and four withdrew from the study, leaving 197 students who participated in the study. Furthermore, we included 180 students who completed more than eighty percent of the program (at least seven out of nine stages) in our analysis.
Adverse events
No adverse events were reported.
Outcome measures
Anxiety symptoms (SCAS) were assessed as the primary outcome. Feasibility, acceptability, and implementation issues of the school-based Journey of the Brave e-learning program were comprehensively evaluated using learning logs (program completion, homework submissions, and comprehension test scores) and post-program satisfaction questionnaires.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065273
