UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058927 |
|---|---|
| Receipt number | R000067393 |
| Scientific Title | Study II on the Effectiveness and Dissemination of Parent Training for Nursery Teachers |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/29 12:59:53 |
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Basic information
Public title
Study II on the Effectiveness and Dissemination of Parent Training for Nursery Teachers
Acronym
Study II on the Effectiveness and Dissemination of Parent Training for Nursery Teachers
Scientific Title
Study II on the Effectiveness and Dissemination of Parent Training for Nursery Teachers
Scientific Title:Acronym
Study II on the Effectiveness and Dissemination of Parent Training for Nursery Teachers
Region
| Japan |
Condition
Condition
Children with developmental special needs
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether teacher training conducted by nursery teachers can produce outcomes comparable to those achieved by an occupational therapist.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participants in the teacher training will complete the Caregiver-Teacher Report Form (C-TRF) and the Canadian Occupational Performance Measure (COPM) one month before the training, immediately before and after the training, and one month after its completion.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention is conducted through a Teacher Training program consisting of ten 60-minute sessions held biweekly. Each session focuses on a specific theme, and participants are expected to implement homework activities with the target child at their nursery school. Homework tasks include observing the child's behavior, conducting special time, providing positive praise, giving achievable instructions, and creating a token chart.
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 | months-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The target child has no formal diagnosis and is not receiving special support. Participation in the study has been approved by the child's parent. The nursery teacher responsible for the child has consented to participate in the study and expressed a desire to learn better ways to communicate and interact with the child through the Teacher Training program.
Key exclusion criteria
Children who may experience emotional strain due to the homework, or whose parents do not consent to participation in this study, will be excluded.
Nursery teachers who may experience emotional fatigue from the homework or from reporting in front of other teachers, or who do not consent to participate in the study, will also be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | Toeda |
| Last name | Umemoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
027-220-8953
to.haruka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | Toeda |
| Last name | Umemoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8511
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
027-220-8953
Homepage URL
to.haruka@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Gunma University
Address
3-39-22 Syowa-machi, Maebashi-City
Tel
027-220-8953
to.haruka@gunma-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 | 08 | Month | 29 | 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 | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | 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 | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067393
