UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049762 |
|---|---|
| Receipt number | R000056532 |
| Scientific Title | E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2022/12/13 15:39:16 |
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Basic information
Public title
E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Acronym
E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Scientific Title
E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Scientific Title:Acronym
E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Region
| Japan |
Condition
Condition
Neurodevelopmental disorders
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study implements e-learning teacher training (e-LTT) for regular primary school teachers and checks the feasibility of the research procedure and the acceptability of the intervention program, as a feasibility study.
Basic objectives2
Others
Basic objectives -Others
This study checks the feasibility of the research procedure and the acceptability of the intervention program.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Feasibility of research procedures and acceptability of the intervention program
Evaluation time (10 weeks after the start of the intervention)
-Teachers' frequency of use of classroom management strategies
Evaluation time (Before the intervention, 10 weeks after the start of the intervention, 16 weeks after the start of the intervention)
Key secondary outcomes
-Teachers' performance in taking e-LTT
Evaluation time (10 weeks after the start of the intervention)
-Teachers' self-efficacy,
-Teachers' stress,
-Teachers' burnout
Evaluation time (Before the intervention, 10 weeks after the start of the intervention, 16 weeks after the start of the intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Maneuver |
Interventions/Control_1
Intervention period: 10 weeks
Intervention content: e-Learning Teacher Training Program
(20 minutes of video-learning times 5, 70 minutes of consultation with TV conference system times 5)
Interventions/Control_2
Control group: after the 10 weeks of the intervention group's receiving training and 6 weeks of follow-up, this group will be able to attend the program for 20 minutes times 5 of video-learning.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Regular classroom teachers who have children in their class who have a diagnosis or tendency toward ADHD or ASD and wish to learn how to deal with them
Key exclusion criteria
*If they have taken / will take TT within the past 2 months to the end of the study
*If they are not working for more than 4 days a week from the time of recruitment to the end of follow-up data collection
*If they have difficulty attending the program in Japanese
*If they have a serious mental illness that makes it difficult for them to participate in TT
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Ishii |
Organization
United Graduate School of Child Development,
Osaka University
Division name
Molecular Research Center for Children's Mental Development
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3863
aishii@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Ishii |
Organization
United Graduate School of Child Development, Osaka University
Division name
Molecular Research Center for Children's Mental Development
Zip code
565-0871
Address
2-2, Yamadaoka, Suita City, Osaka
TEL
06-6879-3863
Homepage URL
aishii@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka 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
Graduate School of Human Science, Osaka University
Address
1-2, Yamadaoka, Suita City, Osaka
Tel
06-6879-8120
n/a
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
| 2022 | Year | 12 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 13 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056532
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
