UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046217
Receipt number R000052573
Scientific Title A Study on the Effect of Mental Health Education for School Teachers on Suicide Prevention
Date of disclosure of the study information 2021/11/29
Last modified on 2024/02/03 13:58:31

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Basic information

Public title

Kanagawa Prefecture School Suicide Prevention Support Project

Acronym

ReSPE-K

Scientific Title

A Study on the Effect of Mental Health Education for School Teachers on Suicide Prevention

Scientific Title:Acronym

A Study on the Effect of Mental Health Education for School Teachers on Suicide Prevention

Region

Japan


Condition

Condition

School teachers with no health problems

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is desirable for school teachers to have mental health literacy as a member of the front line in dealing with the onset of mental illness and risk of suicide among students in their childhood and adolescence. However, efforts to achieve this goal and to examine methodologies have only just begun. This study considers mental health education for school teachers as a form of health promotion, and compares the following three types of knowledge provision in a cluster randomized controlled trial to determine which is more effective in eliminating prejudice against mental illness among school teachers and in acquiring and retaining knowledge. The three approaches to knowledge provision are: (1) a psychiatric approach, which emphasizes knowledge of the disease and risks based on etiology; (2) a psychological support approach, which emphasizes detection of crisis states and response to problems based on health generation theory; and (3) a social support approach, which examines suicide prevention based on the Comprehensive Suicide Prevention Outline. Through this study, we will examine effective ways of disseminating knowledge to school teachers and clarify how medical care and education can work together.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

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)
Japanese version of Reported and Intended Behaviour Scale:RIBS-J


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

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



Eligibility

Age-lower limit

22 years-old <

Age-upper limit

65 years-old >

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


Research contact person

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


Public contact

Name of contact person

1st name Hidehito
Middle name
Last name Miyazaki

Organization

Yokohama City University Medical Center

Division name

Altitude Emergency and critical care medical center

Zip code

232-0024

Address

4-57 Urafunecho, Minami-ku, Yokohama

TEL

045-261-5656

Homepage URL

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

Email

hidem1117pc@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

a

Address

b

Tel

045-370-7627

Email

rinri@yokohama-cu.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

2021 Year 11 Month 29 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

163

Results

The study period was from 2021.4 to 2023.3, and during that period, 6 schools participated in the study. Questionnaires including the Stigma of Suicide Scale (SOSS) were administered before and after the first lecture. There were 163 participants who correctly answered the Stigma of Suicide question of the questionnaire. As a result, the difference between before and after the lecture opened in "Psychological support version".

Results date posted

2024 Year 02 Month 03 Day

Results Delayed


Results Delay Reason

It is suggested that this study reduces the stigma of suicide among school teachers and promotes cooperation between medical care and education. In this study, due to the effects of the new coronavirus infection, we had to use both face-to-face and online format lectures. In the future, we plan to conduct a cluster randomized controlled trial in which the initial lecture was limited to a face-to-face lecture format to further compare effective methods of knowledge dissemination to school teachers.

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

2021 Year 03 Month 30 Day

Date of IRB

2021 Year 03 Month 30 Day

Anticipated trial start date

2021 Year 03 Month 30 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 11 Month 29 Day

Last modified on

2024 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name