UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032275 |
|---|---|
| Receipt number | 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 | 2019/09/04 16:14:52 |
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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
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
cykb1001@mail2.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 24 | 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 | 04 | Month | 16 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036803
