UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056545 |
|---|---|
| Receipt number | R000064617 |
| Scientific Title | Development of a mental health education program to improve mental health literacy among high school students and examination of its effectiveness |
| Date of disclosure of the study information | 2024/12/23 |
| Last modified on | 2025/06/24 10:37:57 |
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Basic information
Public title
Effect of mental health literacy education for high school students
Acronym
Effect of mental health literacy education for high school students
Scientific Title
Development of a mental health education program to improve mental health literacy among high school students and examination of its effectiveness
Scientific Title:Acronym
Study of mental health literacy education for high school students
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim is providing of mental health education for high school students and verify the effectiveness of this education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Mental Health Literacy Scale
Key secondary outcomes
Scale of Attitudes toward seeking help from a psychological professional
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Conduct mental health education classes for high school students.
Interventions/Control_2
Mental health literacy will be measured before and after the class and two weeks later, and changes in scores will be observed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
high school Students who are taking the educational program and have given consent from their own and their guardians.
Key exclusion criteria
If the individual or guardian does not consent to the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasukazu |
| Middle name | |
| Last name | Ogai |
Organization
University of Tsukuba
Division name
Medical Sciences
Zip code
3058577
Address
General Research Building D743, University of Tsukuba, 1-1-1, Tennodai, Tsukuba 305-8577, Japan
TEL
0298533099
ogai.ys@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mitsue |
| Middle name | |
| Last name | Ogawa |
Organization
University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name
doctoral program
Zip code
3058577
Address
General Research Building D743, University of Tsukuba, 1-1-1, Tennodai, Tsukuba 305-8577, Japan
TEL
0298533099
Homepage URL
ogawa.mitsue.xu@alumni.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba,Graduate School of Comprehensive Human Sciences
Institute
Department
Personal name
Mitsue Ogawa
Funding Source
Organization
University of Tsukuba, Support for Pioneering Research Initiated by the Next Generation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba, Graduate School of Comprehensive Human Sciences
Address
General Research Building D743, University of Tsukuba, 1-1-1, Tennodai, Tsukuba 305-8577, Japan
Tel
0298533099
ogawa.mitsue.xu@alumni.tsukuba.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
| 2024 | Year | 12 | Month | 23 | 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
26
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
| 2024 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064617
