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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032275
Receipt No. R000036803
Scientific Title Transdiagnostic intervention for anxiety and depression in children and adolescents
Date of disclosure of the study information 2018/04/19
Last modified on 2019/01/30

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Basic information
Public title Transdiagnostic intervention for anxiety and depression in children and adolescents
Acronym TIADCA study
Scientific Title Transdiagnostic intervention for anxiety and depression in children and adolescents
Scientific Title:Acronym TIADCA study
Region
Japan

Condition
Condition separation anxiety disorder, social phobia, specific phobia, generalized anxiety disorder, dysthymic disorder, major depressive disorder, minor depressive disorder
Classification by specialty
Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate CBT for Japanese children and adolescents with anxiety and/or depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anxiety Disorders Interview Schedule for DSM-IV(ADIS)
Key secondary outcomes Spence Children's Anxiety Scale (SCAS), Depression Self-Rating Scale for Children (DSRS), Spence Children's Scale for Parents (SCAS-P), Depression Self-Rating Scale for Parents (DSRS-P), Strengths and Difficulties Questionnaire for Children (SDQ-C), Strengths and Difficulties Questionnaire for Parents (SDQ-P), Children's Pleasant Activity Scale (CPAS), Children's Avoidance Behavior Scale (CABS)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 cognitive behavioral intervention
Interventions/Control_2 control
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
9 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Inclusion criteria were a current clinical (ADIS CSR > 3) or subclinical (ADIS CSR = 2-3) principal diagnosis of either a DSMIV-TR unipolar depression disorder (Major Depressive Disorder, Minor Depression, or Dysthymia) or an anxiety disorder (Generalized Anxiety Disorder, Social Phobia, Separation Anxiety, or Specific Phobia).
Key exclusion criteria not fulfill criteria for mental retardation, ASD, ADHD, PTSD, eating disorder or substance-related disorder.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kishida
Organization Doshisha University
Division name Graduate School of Psychology
Zip code
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-8220
Email cykb1001@mail2.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Kishida
Organization Doshisha University
Division name Graduate School of Psychology
Zip code
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL 0774-65-8220
Homepage URL
Email cykb1001@mail2.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Research Fellow of the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 17090
Org. issuing International ID_1 the IRB in Doshisha university
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)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 19 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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 16 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036803

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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