UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054295 |
|---|---|
| Receipt number | R000061285 |
| Scientific Title | A Preliminary Study on the Efficacy of Parent Training for Anger in Children |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/05/13 16:32:59 |
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Basic information
Public title
A Preliminary Study on the Efficacy of Parent Training for Anger in Children
Acronym
A Preliminary Study on the Efficacy of Parent Training for Anger in Children
Scientific Title
A Preliminary Study on the Efficacy of Parent Training for Anger in Children
Scientific Title:Acronym
A Preliminary Study on the Efficacy of Parent Training for Anger in Children
Region
| Japan |
Condition
Condition
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 parent training for anger in children.
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 Parents: ARI-P
Key secondary outcomes
Clinical Global Impairment/Improvement Scale: CGIS
Aggressive Behavior Scale for Children and Adolescents: ABS-CA
Disruptive Behavior Disorder Rating Scale: DBDRS
Strengths and Difficulties Questionnaire: SDQ
Parenting Behaviors Questionnaire: PBQ
Quick Inventory of Depressive Symptomatology: QIDS
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
A Parent Training Program for Anger in Children, which consists of a total of eight sessions, is to be implemented.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Child aged 8-12 years
Child with Oppositional Defiant Disorder (clinical problem (ADIS CSR > 4, ADIS CSR = 4)
Parent and child are able to participate in the program regularly
Key exclusion criteria
Currently, there are medical and psychosocial problems in children and families that should be treated as a priority.
The child has PTSD, predisposition disorder, eating disorder, or schizophrenia.
The child is currently receiving medication or other psychotherapy.
The child is scheduled to start medication or other psychotherapy during the course of this study.
The principal investigator, a clinical psychologist or licensed psychologist, determines that participation in this study is not appropriate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sato |
Organization
Kwansei Gakuin University
Division name
Shool of Humanities
Zip code
662-8501
Address
1-155 Ichibancho, Uegahara, Nishinomiya City, Hyogo Prefecture
TEL
0798-54-6201
satokan@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Kishida |
Organization
Kwansei Gakuin University
Division name
Shool of Humanities
Zip code
662-8501
Address
1-155 Ichibancho, Uegahara, Nishinomiya City, Hyogo Prefecture
TEL
0798-54-6201
Homepage URL
https://psyser.kwansei.ac.jp/activities/
kg.parenting@gmail.com
Sponsor or person
Institute
Kwansei Gakuin 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
Kwansei Gakuin University
Address
1-155 Ichibancho, Uegahara, Nishinomiya City, Hyogo Prefecture
Tel
079-565-9052
med-ethic@kwansei.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
| 2024 | Year | 05 | Month | 01 | 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
12
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
| 2023 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061285
