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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048121
Receipt No. R000054784
Scientific Title A Preliminary Study of Efficacy of a Cognitive Behavioral Therapy Program for Emotional Problems in Children and Adolescents
Date of disclosure of the study information 2022/06/22
Last modified on 2022/06/22

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Basic information
Public title A Preliminary Study of Efficacy of a Cognitive Behavioral Therapy Program for Emotional Problems in Children and Adolescents
Acronym A Preliminary Study of Efficacy of a Cognitive Behavioral Therapy Program for Emotional Problems in Children and Adolescents
Scientific Title A Preliminary Study of Efficacy of a Cognitive Behavioral Therapy Program for Emotional Problems in Children and Adolescents
Scientific Title:Acronym A Preliminary Study of Efficacy of a Cognitive Behavioral Therapy Program for Emotional Problems in Children and Adolescents
Region
Japan

Condition
Condition Separation Anxiety Disorder, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder, Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorder
Classification by specialty
Pediatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine feasibility and efficacy of a transdiagnostic cognitive behavioral therapy program for emotional problems (anxiety, depression, and anger) in children and adolescents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Anxiety Disorders Interview Schedule (ADIS)
Affective Reactivity Index for Children and Parents (ARI-C, ARI-P)
Key secondary outcomes Clinical Global Impairment/Improvement Scale (CGIS)

Spence Children's Anxiety Scale (SCAS)
Depression Self-Rating Scale for Children (DSRS-C)
Strengths and Difficulties Questionnaire (SDQ)
Anger Scale for Children and Adolescents (ASCA)
Anger Children's Automatic Thought Scale (A-CATS)
Anger Children's Cognitive Error Scale (A-CCES)

Spence Children's Anxiety Scale for Parents (SCAS-P)
Depression Parent-Rating Scale for Children (DPRS-C)
Disruptive Behavior Disorder Rating Scale (DBDRS)
Strengths and Difficulties Questionnaire for Parents (SDQ-P)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Transdiagnostic Cognitive Behavioral Therapy Program
Interventions/Control_2
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
8 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Child aged 8-15 years
Child with emotional problems (anxiety, depression, and/or anger)
Child with Anxiety Disorder, Depressive Disorder, and/or Externalizing Disorder (ODD, ADHD) (clinical problem (ADIS CSR > 4, ADIS CSR = 4) or subclinical problem (ADIS CSR = 2-3))
Both parent and child are able to participate in the program regularly
Child is able to understand the program (IQ > 80, IQ = 80)
Key exclusion criteria Child with PTSD, Conduct Disorder, Eating Disorder, or Schizophrenia
Child has current suicide-related issues
Child currently receives medication or other psychotherapy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Kohei
Middle name
Last name Kishida
Organization Doshisha University
Division name Faculty of Psychology
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto, Japan
TEL 0774-65-7762
Email kkishida@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name Kohei
Middle name
Last name Kishida
Organization Doshisha University
Division name Faculty of Psychology
Zip code 610-0394
Address 1-3 Tatara Miyakodani, Kyotanabe City, Kyoto, Japan
TEL 0774-65-7762
Homepage URL http://pscenter.doshisha.ac.jp/event/index.php?c=topics2_view&pk=1655086565
Email kkishida@mail.doshisha.ac.jp

Sponsor
Institute Doshisha University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 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
2022 Year 06 Month 22 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
2022 Year 06 Month 10 Day
Date of IRB
2022 Year 05 Month 11 Day
Anticipated trial start date
2022 Year 06 Month 22 Day
Last follow-up date
2024 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
2022 Year 06 Month 21 Day
Last modified on
2022 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054784

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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