UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031274 |
|---|---|
| Receipt number | R000035705 |
| Scientific Title | Development and Evaluation of Mental Health Literacy Education Program for High School Students |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2018/02/13 15:16:41 |
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Basic information
Public title
Development and Evaluation of Mental Health Literacy Education Program for High School Students
Acronym
Development of Mental Health Literacy Education Program
Scientific Title
Development and Evaluation of Mental Health Literacy Education Program for High School Students
Scientific Title:Acronym
Development of Mental Health Literacy Education Program
Region
| Japan |
Condition
Condition
mental disorder
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate an educational program for high school students
Basic objectives2
Others
Basic objectives -Others
To promote mental health literacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To increase help seeking behavior
Key secondary outcomes
To achieve knowledge for mental disorders
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
mental health literacy education program
50 minutes
maximum 2 times
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
| 15 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who tolerate these classes
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | soichi takamura |
Organization
University of Shizuoka
Division name
School of Nursing
Zip code
Address
2-2-1, Oshika, Suruga-ku,Shizuoka-city
TEL
054-202-2649
takamura.soichi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | soichi takamura |
Organization
University of Shizuoka
Division name
School of Nursing
Zip code
Address
2-2-1, Oshika, Suruga-ku,Shizuoka-city
TEL
054-264-2649
Homepage URL
takamura.soichi@gmail.com
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
Address
Tel
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
| 2018 | Year | 02 | Month | 14 | 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
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035705
