UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048121 |
|---|---|
| Receipt number | 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 | 2023/09/15 10:28:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kkishida@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054784
