UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047217 |
|---|---|
| Receipt number | R000033708 |
| Scientific Title | Effectiveness of a cognitive behavioural therapy-based anxiety prevention education program for elementary and junior high school students |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2024/11/13 09:50:14 |
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Basic information
Public title
Effectiveness of a cognitive behavioural therapy-based anxiety prevention education program for elementary and junior high school students
Acronym
Effectiveness of CBT-based anxiety prevention program
Scientific Title
Effectiveness of a cognitive behavioural therapy-based anxiety prevention education program for elementary and junior high school students
Scientific Title:Acronym
Effectiveness of CBT-based anxiety prevention program
Region
| Japan |
Condition
Condition
Elementary school children aged 10-12
Junior high school children aged 13-15
Parents
Teachers
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in children and teacher's anxiety scores before and after a cognitive-behavioral program implemented at school
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the intervention by comparing the intervention and control groups.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spence Children's Anxiety Scale: SCAS for children and parents
(pre, post, 3 months follow-up)
Key secondary outcomes
Emotion-Regulation Skills Questionnaire: ERSQ (pre, post, 3 months follow-up)
Strength and Difficulties Questionnaire: SDQ (pre, post, 3 months follow-up)
PHQ-9 (pre, post)
GAD-7 (pre, post)
Psychological safty scale for workers (pre, post)
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
| Other |
Interventions/Control_1
The Journey of the Brave
Cognitive behavioral therapy based anxiety prevention education program
Interventions/Control_2
Regular classes
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children attending the elementary school in grade 4-6 or the junior high school in grade 1-3 and their parents, teachers
Key exclusion criteria
children not attending school and their parents
Target sample size
3000
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
260-8670
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
TEL
043-226-2975
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Urao |
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
yurao@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University School of Medicine Ethics Committee
Address
1-8-1 Inohana, Chuouku, Chiba, Japan
Tel
043-226-2501
igaku-rinri@office.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 | 03 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2022 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033708
