UMIN-ICDS Clinical Trial

Public title

Kanagawa Prefecture School Suicide Prevention Support Project

Acronym

ReSPE-K

Scientific Title

A Study on the Effectiveness of Mental Health Education for Suicide Prevention in a Face-to-Face Lecture Format for School Teachers

Scientific Title:Acronym

A Study on the Effectiveness of Mental Health Education for Suicide Prevention in a Face-to-Face Lecture Format for School Teachers

Region

Japan

Condition

School teachers with no health problems

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

School teachers should have mental health literacy as members of the front line in responding to the risk of mental illness and suicide among children and adolescents. However, efforts and methodological validation for this purpose have only just begun. In this study, mental health education for school teachers will be considered as one of the health promotion programs, and a cluster randomized controlled trial will be conducted to determine which of the following three types of knowledge provision is more effective in reducing prejudice against mental illness among school teachers and increasing their acquisition and retention of knowledge. The knowledge provision will be 1) a "psychiatric approach," which emphasizes knowledge of illness and risks based on etiology, 2) a "psychological support approach," which emphasizes detection of crisis conditions and response to illness based on health generation theory, and 3) a "social support approach," which examines suicide prevention based on the Comprehensive National Suicide Prevention Strategy. Through this study, we will examine effective ways to disseminate knowledge to school teachers and clarify how medical care and education should work together.
We conducted the same study as "Research on the Effectiveness of Mental Health Education for School Teachers for Suicide Prevention" from 2021, but due to the spread of the new coronavirus infection, we had to combine the face-to-face lecture format with an online format for knowledge provision. After the lecture, many school teachers commented that they had different impressions of the face-to-face lecture format and the online format. Therefore, a new study was planned to limit the initial knowledge provision to the face-to-face lecture format.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Japanese version of the Stigma of Suicide Scale: SOSS (immediately before and after the lecture)

Key secondary outcomes

Japanese version of the Stigma of Suicide Scale:SOSS (6 months later, after the third lecture)
Japanese version of the Literacy of Suicide Scale: LOSS-J (immediately before the lecture and after the third lecture)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Three types of lectures will be given in two years. The intervals between lectures are one year and four to six months for the first two lectures and the second and third lectures, respectively. The interval between lectures is one year for the first two lectures and four to six months for the second and third lectures, respectively. All groups were set up so that they could complete the three types of lectures in two years. Materials on suicide prevention will be distributed 6 months after the social lectures. There will be three types of lectures: Psychiatry,Psychological Support and Social Support.
The order of the lectures will be as follows: 1) Psychiatry, 2) Psychological support, 3) Social support.

Interventions/Control_2

The order of the lectures will be as follows: 2) Psychological support, 3) Social support, 1) Psychiatry.

Interventions/Control_3

The order of the lectures will be as follows: 3) Social support, 1) Psychiatry, 2) Psychological support.

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

All positions of teachers

Key exclusion criteria

Those who were unable to obtain the consent of the principal of the school to which they belonged, midway participants, and participants who dropped out of the program (those whose prior answers were completely missing)

Target sample size

400

Name of lead principal investigator

1st name	Junichi
Middle name
Last name	Fujita

Organization

Yokohama City University Hospital

Division name

Child Psychiatry

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Email

jun1182@yokohama-cu.ac.jp

Name of contact person

1st name	Hidehito
Middle name
Last name	Miyazaki

Organization

Yokohama City University

Division name

Department of Psychiatry

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Homepage URL

http://www-user.yokohama-cu.ac.jp/~ycucap/?page_id=2854

Email

hidempc3@yokohama-cu.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University Ethics Committee on Life Sciences and Medical Research Involving Human Subjects

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

Tel

045-370-7627

Email

rinri@yokohama-cu.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

2024

Year

02

Month

03

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

Open public recruiting

Date of protocol fixation

2023

Year

07

Month

04

Day

Date of IRB

2023

Year

07

Month

04

Day

Anticipated trial start date

2023

Year

07

Month

04

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

02

Month

03

Day

Last modified on

2024

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061090