UMIN-CTR 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 | 2025/08/22 10:37:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
88
Results
The dropout rate was 23.8%, and 83.9% of the children and 96.8% of the parents responded positively regarding their overall satisfaction. The SCAS-P showed a significant decrease between Pre and FU (p = 0.014, 95% CI = (-9.22, -0.84)). However, the decrease in SCAS-C was not significant (p = 0.08). The ERSQ also increased significantly between Pre and FU (p = 0.045, 95% CI = (0.18, 18.31)).
Results date posted
| 2024 | Year | 10 | Month | 13 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Paper submission in progress
Date of the first journal publication of results
Baseline Characteristics
Participants were fifth- and sixth-grade students (aged 10-12 years) enrolled in regular classes. The same parent was required to answer all the questionnaires. Because this was a preventive intervention program, we excluded children who were not attending school, were enrolled in special-needs classes, were diagnosed with developmental disabilities or mental disorders, or attended psychiatric hospitals.
Participant flow
We recruited participants through the official website and flyers distributed to approximately 1,500 children through several schools in the Chiba and Ibaraki prefectures from August to September 2022. In the flyer, we included the aim and overview of the study, eligibility and exclusion criteria, and the computer and network requirements necessary to take the e-learning program. Applications and informed consent forms were available on the website, accessible via a QR code on the flyer. Participants could apply only if they had read and agreed to the written instructions. Furthermore, the children's assent document, written in plain language, was posted on the website to ensure that children were not forced to participate only because of their parents' wishes, and we also made it possible to check the children's own willingness to participate when they applied for the program.
Adverse events
This is a learning program related to mental health, therefore no adverse events are expected.
Outcome measures
Feasibility was comprehensively evaluated through dropout rates, satisfaction and learning records, and changes in scores on psychological scales assessing anxiety symptoms, emotion-regulation skills, and children's emotional and behavioral problems.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056019
