UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047218 |
|---|---|
| Receipt number | R000052327 |
| Scientific Title | The effect of the Journey of the Brave Program on the Anxiety, Happiness and Life Adaptation of Taiwanese Primary School Children |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2024/09/18 09:23:06 |
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Basic information
Public title
The effect of the Journey of the Brave Program on the Anxiety, Happiness and Life Adaptation of Taiwanese Primary School Children
Acronym
The effect of the "JOB" Program on the Anxiety, Happiness and Life Adaptation of Taiwanese Primary School Children
Scientific Title
The effect of the Journey of the Brave Program on the Anxiety, Happiness and Life Adaptation of Taiwanese Primary School Children
Scientific Title:Acronym
The effect of the "JOB" Program on the Anxiety, Happiness and Life Adaptation of Taiwanese Primary School Children
Region
| Asia(except 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 efficacy and acceptability of CBT-based universal prevention program for reducing anxious symptoms
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spence Children's Anxiety Scale: SCAS (Taiwan Chinese)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
CBT-based universal anxiety prevention program
Interventions/Control_2
Receive regular school curriculum
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
Key exclusion criteria
Children not attending the school
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hsiulan |
| Middle name | |
| Last name | Tien |
Organization
National Taiwan Normal University
Division name
Department of Educational Psychology and Counseling, College of Education
Zip code
106308
Address
162, Section 1, Heping E. Rd., Taipei City 106, Taiwan
TEL
+88627749-3753
tienhsiulan@gmail.com
Public contact
Name of contact person
| 1st name | Isana |
| Middle name | |
| Last name | Kaichi |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
Homepage URL
afda7935@chiba-u.jp
Sponsor or person
Institute
National Taiwan Normal 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
National Taiwan Normal University
Address
162, Section 1, Heping E. Rd., Taipei City 106, Taiwan
Tel
+886277493753
tienhsiulan@gmail.com
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 | 03 | Month | 18 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s12888-023-05134-8
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1186/s12888-023-05134-8
Number of participants that the trial has enrolled
16
Results
The results of this study indicated that the JBCP had immediate and follow-up effects on the separation anxiety in the experimental group. With the pretest impact eliminated, the immediate and follow-up effects on overall anxiety in the experimental group were better than those on the control group. However, even though the immediate and follow-up effects of the JBCP on the experimental group were better than the control group but were not significant.
Results date posted
| 2024 | Year | 09 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children in an elementary school in Taoyuan City, between ages 11 and 12.
Participant flow
After obtaining the consents of the participants and their parents, we randomly assigned the participants into the experimental group and the control group.
The experimental group received a 40-minute JBCP session weekly for ten weeks. The control group received a 40-minute career exploration small group counseling weekly for ten weeks.
Adverse events
None
Outcome measures
We administered the SCAS, Psychological Well-Being Scale, and School Life Adjustment Scale in the pretest, posttest, and follow-up test to measure change of anxiety, well-being, and life adjustment of the participants.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052327
