UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045483 |
|---|---|
| Receipt number | R000051796 |
| Scientific Title | Development of an e-learning program for school teachers to support children of parents with mental illness |
| Date of disclosure of the study information | 2021/09/20 |
| Last modified on | 2022/09/02 18:47:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an e-learning program for school teachers to support children of parents with mental illness
Acronym
I'm here
Scientific Title
Development of an e-learning program for school teachers to support children of parents with mental illness
Scientific Title:Acronym
I'm here
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop an e-learning program for elementary school teachers to support children with parents with mental illness. The elementary school teachers watch the created training video program, and answer a web survey before and after that to exam the effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Support coping difficulty scale (1 month later)
Key secondary outcomes
Behaviors related to finding and coping with children of parents with mental illness
Knowledge of children of parents with mental illness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Watch a 30-minute e-learning video. The content of the video is a brief explanation of mental illness, how parents' mental illness affects their children's lives, concrete examples, flow of support, what they want to ask school teachers, and becoming an adult.
Interventions/Control_2
No intervention
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
Elementary school full-time teacher
Key exclusion criteria
Teachers who have difficulty understanding Japanese and teachers who cannot perform web surveys or video viewing operations.
Target sample size
244
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kageyama |
Organization
Osaka University
Division name
Institute of Advanced Co-Creation Studies/ Division of Health Sciences, Graduate School of Medicine
Zip code
565-0871
Address
Yamadaoka 1-7, Suita, Osaka, Japan, 565-0871
TEL
06-6879-2553
kageyama@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Kageyama |
Organization
Osaka University
Division name
Institute of Advanced Co-Creation Studies/ Division of Health Sciences, Graduate School of Medicine
Zip code
565-0871
Address
Yamadaoka 1-7, Suita, Osaka, Japan, 565-0871
TEL
06-6879-2553
Homepage URL
kageyama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
Yamadaoka 2-2, Suita, Osaka, Japan
Tel
06-6210-8290
rinri-jim@dmi.med.osaka-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 | 09 | Month | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2022 | 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=R000051796
