UMIN-CTR Clinical Trial

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
Email	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
Email	kageyama@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051796