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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name