UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060019 |
|---|---|
| Receipt number | R000068640 |
| Scientific Title | Effects of Clinical Interventions for Children Exhibiting Challenging Behaviors: An Evaluation Using Single-Case Experimental Design |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/12 00:06:44 |
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Basic information
Public title
Effects of Clinical Support for Children with Challenging Behaviors
Acronym
CB-CS Study
Scientific Title
Effects of Clinical Interventions for Children Exhibiting Challenging Behaviors:
An Evaluation Using Single-Case Experimental Design
Scientific Title:Acronym
SCD-CBI Study
Region
| Japan |
Condition
Condition
Children with Challenging Behaviors
(school refusal, behavioral disorders including aggressive behaviors, and anxiety disorders including obsessive-compulsive disorder and selective mutism)
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effectiveness of clinical interventions, including behavioral therapy, for children exhibiting challenging behaviors such as school refusal, behavioral disorders, and anxiety disorders (including selective mutism), using single-case experimental designs, and to examine the causal relationship between the interventions and behavioral changes in order to identify effective support methods.
Basic objectives2
Others
Basic objectives -Others
To systematically examine the appropriateness of the individually defined target behaviors and clinical intervention procedures for each participant, and to clinically assess the potential for generalization and maintenance of intervention effects across daily life settings such as home and school.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the frequency of individually defined target behaviors for each participant before, during, and after the clinical intervention. Target behaviors are individually defined as observable and measurable behaviors in daily life settings such as home and school, and are continuously evaluated during the intervention period and after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention in this study consists of individualized clinical interventions, including behavioral therapy, designed based on ecological assessments of each participant's challenging behaviors. Specifically, behavioral techniques such as token economy procedures, behavioral contracts, and exposure are applied in combination as appropriate to the participant's characteristics and living environment. The intervention procedures are instructed by the researchers and implemented continuously by caregivers in daily life settings such as home and school.
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children aged 1 to 18 years exhibiting challenging behaviors such as school refusal, behavioral disorders including verbal or physical aggression, or anxiety disorders (including obsessive-compulsive disorder and selective mutism).
2) Caregivers who seek clinical intervention for the child's challenging behaviors.
3) Caregivers who are able to implement the intervention procedures in daily life settings such as home, nursery school, kindergarten, or school in accordance with the researchers' instructions.
4) Caregivers who are capable of appropriately evaluating, recording, and reporting the child's behavioral status to the researchers.
Key exclusion criteria
1) Children who require medical care or intensive medical management due to severe physical and/or intellectual disabilities.
2) Children who are judged by the investigators to be inappropriate for participation in this study for any other clinical or practical reasons.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Narita |
Organization
Kyorin University School of Medicine
Division name
Department of Pediatrics
Zip code
181-8611
Address
Kyorin University School of Medicine 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL
0422-47-5511
masami-narita@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Narita |
Organization
Kyorin University School of Medicine
Division name
Department of Pediatrics
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL
0422-47-5511(23621)
Homepage URL
masami-narita@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
This study is funded by the investigators' own resources. No external funding is provided.
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
Ethics Committee, Kyorin University School of Medicine
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
Tel
0422-47-5511 / +81-422-47-5511
irb@ks.kyorin-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
杏林大学医学部付属病院（東京都）および家庭・学校等の生活場面
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 07 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068640
