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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038128
Receipt No. R000043456
Scientific Title A randomized controlled trial of cultural-adapted and program-adopted cognitive behavioral therapy for children and adolescents.
Date of disclosure of the study information 2020/01/30
Last modified on 2021/01/28

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Basic information
Public title Multi-, Inter-, and Cross-cultural Clinical Child Study
Acronym MIXCS
Scientific Title A randomized controlled trial of cultural-adapted and program-adopted cognitive behavioral therapy for children and adolescents.
Scientific Title:Acronym MIXCS
Region
Japan

Condition
Condition anxiety disorder
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare cultural-adapted and program-adopted cognitive behavioral therapies and identify both cultural specific and universal factors of psychotherapies.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blind evaluation based on the Anxiety Disorders Interview Schedule for DSM-IV for children (ADIS)
Key secondary outcomes Spence Children's Anxiety Scale for children (SCAS) and parents (SCAS-P)
Depression Self-Rating Scale for Children (DSRS)
Children's Cognitive Error Scale (CCES)
Satisfaction, comprehension for children, parents
Competence and Adherence Scale for Cognitive Behavioral Therapy (CAS-CBT)
Cross-cultural Behavioural Observation System (C-BOS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 cultural-adapted cognitive behavior therapy
Interventions/Control_2 program-adopted cognitive behavioral therapy
Interventions/Control_3 morality education control
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
8 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1. children aged 8 to 15 years old
2. both parents and children can participate
3. children fulfilled with any criteria of anxiety disorders
Key exclusion criteria 1. children without externalizing disorders, substance abuse, schizophrenia, and developmental disorders
2. children free from any other treatments or these treatment can be controlled (e.g., washout or fixed)
Target sample size 96

Research contact person
Name of lead principal investigator
1st name Ishikawa
Middle name
Last name Shin-ichi
Organization Doshisha University
Division name Faculty of Psychology
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto, Japan
TEL 0774-65-7092
Email ishinn@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name AAA
Middle name
Last name AAA
Organization Kwansei Gakuin University
Division name Center for psychological services and research
Zip code 663-8204
Address 5-22 Takamatsu-cho, Nishinomiya, Hyogo, Japan
TEL 0798-31-0791
Homepage URL
Email ishinn@mail.doshisha.ac.jp

Sponsor
Institute Faculty of Psychology, Doshisha University
Institute
Department

Funding Source
Organization Research fellow of the Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (B)
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 Doshisha University
Address Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku
Tel 075-251-3158
Email ji-rinri@mail.doshisha.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 XXXXX
Org. issuing International ID_1 Doshisha University Research Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 同志社大学心理臨床センター(京都府)
関西学院大学心理科学実践センター(兵庫県)
信州大学心理教育相談室(長野県)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 30 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 30 Day
Date of IRB
2020 Year 01 Month 30 Day
Anticipated trial start date
2021 Year 08 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
2019 Year 09 Month 27 Day
Last modified on
2021 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043456

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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