UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048178 |
|---|---|
| Receipt number | R000054896 |
| Scientific Title | Intervention effect study for staff in charge of children with developmental disorders |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2024/03/11 11:49:30 |
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Basic information
Public title
Development of staff skill improvement program at child development support office
Acronym
Development of staff skill improvement program at child development support office
Scientific Title
Intervention effect study for staff in charge of children with developmental disorders
Scientific Title:Acronym
Intervention effect study for staff in charge of children with developmental disorders
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether taking teacher training will change the following: Changes in child behavior and relationships with staff in child development support establishments, changes in staff support styles and daily work, and changes in children's behavior at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sutter-Eyberg Stuent Behavior Inventory-Revised,
Eyberg Child Behavior Inventory
Key secondary outcomes
Canadian Occupational Performance Measure,
Student Teacher Relationship Scale,
Parental Child Rearing Scale,
Record of target children by the staff,
What the staff said at the conference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention period for the implementation group is about 12 weeks, and all 7 sessions are conducted every other week for about 1 hour.
Interventions/Control_2
No teacher training is given to the control group
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
| 3 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
target child: children using the child development support offices, children with the consent of their parents
Target person: staff in charge of the target child, staff who got consent
Key exclusion criteria
target child: children who are expected to be mentally burdened by being subject to questionnaires and home work, children who do not get consent from their parents
target person: those who are expected to be mentally burdened by carrying out the homework that is imposed every time they participate in teacher training and reporting the homework in front of others, those who are expected to be mentally tired to answer the questionnaire
Target sample size
60
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 Department
Zip code
371-8514
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
0272208953
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
371-8514
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
0272208953
Homepage URL
to.haruka@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Committee for Humans
Address
3-39-15 Syowa-machi, Maebashi-City
Tel
027-220-8740
hitotaisho-ciru@ml.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
群馬大学，株式会社ワンライフ 児童発達支援事業所chuouchou
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054896
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| Registered date | File name |
| Research case data | |
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