UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061804 |
|---|---|
| Receipt number | R000070724 |
| Scientific Title | A single-arm pre-post study on changes in child behavioral assessment and parents' perceptions through parent training for parents |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/04 20:50:51 |
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Basic information
Public title
A single-arm pre-post study on changes in child behavioral assessment and parents' perceptions through parent training for parents
Acronym
Parent Training Pre-Post Study
Scientific Title
A single-arm pre-post study on changes in child behavioral assessment and parents' perceptions through parent training for parents
Scientific Title:Acronym
Parent Training Pre-Post Study
Region
| Japan |
Condition
Condition
Child behavioral difficulties and parenting difficulties
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in child behavioral assessment and parents' perceptions after parent training for parents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in child behavioral assessment measured using the Japanese version of the Eyberg Child Behavior Inventory (ECBI). Assessments will be conducted before the intervention, after the intervention, and 3 months after completion of 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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Parents will receive a parent training program. The program includes understanding child behavior, positive attention, praise, reflection using behavior record forms, and home practice assignments.
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be parents who participate in the parent training program and who provide informed consent after receiving an explanation of the purpose and methods of the study.
Key exclusion criteria
Individuals who do not provide informed consent, those who have difficulty completing the questionnaires, and those whom the principal investigator judges to be inappropriate for participation in the study will be excluded.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Child and Psychiatric Nursing, Faculty of Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
0245471844
sato-lab@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Child and Psychiatric Nursing, Faculty of Nursing
Zip code
9601295
Address
1 Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
0245471844
Homepage URL
sato-lab@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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, Fukushima Medical University
Address
1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
Tel
0245471825
r-c@fmu.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
| 2026 | Year | 06 | Month | 04 | 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
| 2026 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070724
