UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038128 |
|---|---|
| Receipt number | 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 | 2023/09/30 09:57:54 |
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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
Clinical Significance Ratings (ADIS)
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)
Family Accommodation Scale for Anxiety (FASA) and child report version (FASA-CR)
Competence and Adherence Scale for Cognitive Behavioral Therapy (CAS-CBT)
Cross-cultural Behavioural Observation System (C-BOS)
Satisfaction, comprehension for children, parents
Sustainability for therapists
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. parent/s and child are available to attend the treatment in person,
3. children who meet DSM-IV criteria for an anxiety disorder (i.e., separation anxiety disorder, social anxiety disorder, specific phobia, generalized anxiety disorder)
4. children free from any other treatments or these treatments can be controlled (e.g., washout or fixed period for pharmacotherapies)
Key exclusion criteria
1. children with intellectual developmental disorder
2. children with externalizing disorders, substance abuse, and schizophrenia as primary and secondary diagnoses
3. children with autism spectrum disorder, attention deficit/hyperactivity disorder, specific learning disorder, and other developmental disorders as primary diagnoses
Target sample size
99
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
ishinn@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Takashina |
| Middle name | |
| Last name | Hikari |
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
ishinn@mail.doshisha.ac.jp
Sponsor or person
Institute
Faculty of Psychology, Doshisha University
Institute
Department
Personal name
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
ji-rinri@mail.doshisha.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
19046
Org. issuing International ID_1
Doshisha University Research Ethics Review Committee
Study ID_2
270
Org. issuing International ID_2
Shinshu University Research Ethics Review Committee
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
Individual participant data are unable to be share due to ethical and regulatory considerations.
IPD sharing Plan description
Individual participant data are unable to be share due to ethical and regulatory considerations. However, the study will present the data in the published paper. This will include data that are merged in tables. Interested parties may access this data to replicate our findings. We will make the study protocol and trial registration information available to interested parties. We will make other data that support the findings of our study available upon reasonable request. Interested parties may contact the corresponding author, SI, for access to this data.
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web page(in Japanese)
http://mixcs.jp/
Management information
Registered date
| 2019 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043456
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
