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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032517
Receipt No. 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 2019/05/09

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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
Email 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
Email yurao@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
Email 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
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
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
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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