UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043436 |
|---|---|
| Receipt number | R000049526 |
| Scientific Title | Studies on effectiveness and prevalence of Parent Training for nursery teacher |
| Date of disclosure of the study information | 2021/02/25 |
| Last modified on | 2024/09/02 08:52:57 |
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Basic information
Public title
Studies on effectiveness and prevalence of Parent Training for nursery teacher
Acronym
Studies on effectiveness and prevalence of Parent Training for nursery teacher
Scientific Title
Studies on effectiveness and prevalence of Parent Training for nursery teacher
Scientific Title:Acronym
Studies on effectiveness and prevalence of Parent Training for nursery teacher
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 considering whether the same outcome of teacher training by nursery as Occupational Therapist.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The participants of teacher training complete the Caregiver-Teacher Report Form(C-TRF) on one month prior, just before, right after and one month after.
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
We intervene the participants by the teacher training. 60minutes each session and all ten session every other week. The participants study the session theme, and do homework in the nursery school directed at the target child. The homework includes the observation to the target child, doing the special time, doing the praising, doing the instructions and making the token list.
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 child has no diagnosis and no special supporting and his or her parent consent to this study.
The teacher of the target child, and will study the better communicate the child and consent to this study.
Key exclusion criteria
The child can take emotional strain by the homework and his or her parent does not consent to this study.
The teacher can take emotional strain by the homework and reporting in other teachers, does not consent to this study.
Target sample size
18
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
Japan Science and Technology Agency
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
| 2021 | Year | 02 | Month | 25 | 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
| 2021 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2021 | Year | 02 | Month | 25 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049526
