UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032517 |
|---|---|
| Receipt number | R000037083 |
| Scientific Title | The efficacy of universal CBT-based anxiety prevention program for children and adolescents |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2024/11/13 09:29:09 |
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Basic information
Public title
The efficacy of universal CBT-based anxiety prevention program for children and adolescents
Acronym
The efficacy of universal CBT-based anxiety prevention program for children and adolescents
Scientific Title
The efficacy of universal CBT-based anxiety prevention program for children and adolescents
Scientific Title:Acronym
The efficacy of universal CBT-based anxiety prevention program for children and adolescents
Region
| Japan |
Condition
Condition
Elementary school children aged 10-13
Junior high school students aged 13-15
High school students aged 16-18
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
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spence Children's Anxiety Scale: SCAS
Key secondary outcomes
Depression Self-Rating Scale for Children:DSRS
Strengths and Difficulties Questionnaire:SDQ
Child and Adolescent Mindfulness Measure:CAMM
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
Waiting
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children attending the elementary school in grade 4-6
Students attending the junior high school in grade 1-3
Students attending the high school in grade 1-3
Key exclusion criteria
Children not attending the school
Target sample size
2000
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
2608670
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
2608670
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University school of medicine
Address
1-8-1, Inohana, Chuoku, Chiba, Japan
Tel
043-226-2496
inohana-kanri@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
| 2018 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1186/s12888-023-05134-8
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1186/s13034-021-00374-6
Number of participants that the trial has enrolled
3022
Results
The results demonstrated that ten 45-min JOB sessions conducted in Japanese elementary schools, delivered by specially trained teachers, were associated with a statistically significant anxiety score reduction among the participating students, when compared with a control group.
Results date posted
| 2024 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-seven elementary schools participated: 1622 and 1123 children were allocated to the intervention and control groups, respectively. The intervention group received a programme comprising ten 45-min sessions, while the control group underwent the regular school curriculum.
Participant flow
In recruiting participating schools, we contacted member universities of the Kodomo Minna Project (http://www.kodomo-minna.jp/) through their cooperating education boards.
Each participating education board or university distributed an announcement letter soliciting participation, along with an application form and pamphlet explaining the content to jurisdictional elementary schools.
Thirty schools willingly participated in this study. They were geographically separated into three different areas: Chiba, Tottori, and Kyoto prefectures.
Adverse events
None
Outcome measures
The primary outcome of this study was changes in the SCAS Japanese version scores.
The SCAS is an anxiety scale that has been shown to have good psychometric properties and has been commonly used with children of various cultural backgrounds in multiple countries.
It contains six subscales generalised, anxiety disorder, separation anxiety disorder, social phobia, panic disorder and agoraphobia, obsessive compulsive disorder, and fear of physical injury.
Each item is rated on a 4 point scale in terms of its frequency, from never to always.
A total anxiety score is calculated by adding the 38 item' scores, with a maximum possible score of 114.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2018 | Year | 05 | Month | 08 | 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=R000037083
