UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057516 |
|---|---|
| Receipt number | R000065590 |
| Scientific Title | Cognitive behavioral therapy for anxiety disorders in at-risk young children: A randomized controlled trial |
| Date of disclosure of the study information | 2025/06/10 |
| Last modified on | 2025/04/04 15:55:21 |
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Basic information
Public title
Cognitive behavioral therapy for anxiety disorders in at-risk young children: A randomized controlled trial
Acronym
Cognitive behavioral therapy for anxiety disorders in at-risk young children
Scientific Title
Cognitive behavioral therapy for anxiety disorders in at-risk young children: A randomized controlled trial
Scientific Title:Acronym
CBT for anxiety disorders in at-risk young children: RCT
Region
| Japan |
Condition
Condition
anxiety disorders
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary aim is to evaluate the effectiveness of the provision of a parent-led intervention compared with usual school practice for children (aged 4-5) identified as at risk for anxiety disorders based on screening positive for one or more risks (child anxiety symptoms, and/or behavioural inhibition, and/or parental anxiety). And we hypothesise that fewer children will have an anxiety disorder in the intervention groups compared to the control groups at 12 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anxiety Disorders Interview Schedule
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will undergo cognitive behavioral therapy (CBT), including with the parents. Program components from previous CBT programs used in Western countries (e.g. Creswell et al., 2017) were reviewed, and a detailed protocol was developed (Japanese version of the CBT adapted to the Japanese culture and education system).
Interventions/Control_2
The control group received regular kindergarten and nursery school education.
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study setting is mainstream kindergarten/nurseries in Japan, second year classes (aged 4-5). Children who scored 34 or above on the parent-rated scale (Preschool Anxiety Scale: PAS) were included.
Key exclusion criteria
The exclusion criteria were: having been diagnosed with a developmental disorder or intellectual disability
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Takahashi |
Organization
University of Miyazaki
Division name
Educational Clinical Psychology
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-Nishi, Miyazaki
TEL
0985-58-7457
takahito@cc.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Takahashi |
Organization
University of Miyazaki
Division name
Educational Clinical Psychology
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-Nishi, Miyazaki
TEL
0985-58-7457
Homepage URL
takahito@cc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
University of Miyazaki
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki
Address
1-1 Gakuen Kibanadai-Nishi, Miyazaki
Tel
0985-58-7457
takahito@cc.miyazaki-u.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
| 2025 | Year | 06 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065590
