UMIN-ICDS Clinical Trial

Public title

Knowledge and understanding of mental health in school teachers

Acronym

Knowledge and understanding of mental health in school teachers

Scientific Title

Mental health literacy for school teachers

Scientific Title:Acronym

Mental health literacy for school teachers

Region

Japan

Condition

Mental health literacy

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of a mental health literacy education program developed for school teachers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Mental health literacy will be assessed using a self-reported questionnaire as follows.
1. General knowledge about mental illness, increase of mental illness and suicide in teens will be assessed using items developed for this study by the authors.
2. Teachers' ability to respond to children at risk of mental illness and suicide will be evaluated, using case vignettes and options (desirable and undesirable responses to the cases).
3. Whether teachers think that preventing mental illnesses and suicide among children as their role will be assessed. Also, whether they are confident in dealing with children at risk of mental illness or suicide will be evaluated.
4. Each outcome will be assessed at immediately before and after the intervention.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Intervention group
A 20-minute program regarding mental health literacy will be delivered. The program will be taught using slides with narration. Main topics of the program will be as follows: (1) the prevalence of mental illnesses and suicide increases in teens, (2) mental illnesses are common diseases that are experienced by 1 in 5 people, (3) children with mental health problems rarely seek help from adults on their own, so adults need to recognize and respond to children's problems, (4) how to deal with children's mental health problems and the risk of suicide, etc.

Interventions/Control_2

Control group
10-20 minutes educational program on teachers' responses to the problem of bullying will be delivered.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

School Teachers.

Key exclusion criteria

None

Target sample size

5000

Name of lead principal investigator

1st name	Tsukasa
Middle name
Last name	Sasaki

Organization

The University of Tokyo

Division name

Department of Physical and Health Education, Graduate School of Education

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-Ku, Tokyo

TEL

0358413985

Email

psytokyo@yahoo.co.jp

Name of contact person

1st name	Tsukasa
Middle name
Last name	Sasaki

Organization

The University of Tokyo

Division name

Department of Physical and Health Education, Graduate School of Education

Zip code

1130033

Address

7-3-1 Hongo, Bunkyo-Ku, Tokyo

TEL

0358413985

Homepage URL

Email

psytokyo@yahoo.co.jp

Institute

Department of Physical and Health Education, Graduate School of Education, The University of Tokyo

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of the University of Tokyo

Address

7-3-1 Hongo, Bunkyo-Ku, Tokyo

Tel

0358410284

Email

lifescience.adm@gs.mail.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2023

Year

06

Month

16

Day

Date of IRB

2022

Year

12

Month

16

Day

Anticipated trial start date

2023

Year

06

Month

16

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Scientific Title of the present registration is different from the title submitted to the research ethics committee ("Mental health literacy for schoolteachers and parents"), since only schoolteachers will be targeted to this study.

Statistical analysis
All analyses will be carried out on an intention-to-treat basis. In accordance with Yamaguchi et al. (2020), mixed-effects models, i.e., linear mixed models and logistic regression mixed models will be used for the analyses of continuous and dichotomous outcome variables.
Yamaguchi et al., Journal of Adolescent, 82:58-66, 2020.

Registered date

2023

Year

06

Month

16

Day

Last modified on

2023

Year

07

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058587