UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045325 |
|---|---|
| Receipt number | R000051685 |
| Scientific Title | The effectiveness of the online peer gatekeeper training program for the student on suicide prevention: a randomized controlled trial |
| Date of disclosure of the study information | 2021/08/31 |
| Last modified on | 2022/04/26 11:38:42 |
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Basic information
Public title
The effectiveness of the online peer gatekeeper training program for the student on suicide prevention
Acronym
The effectiveness of the online peer gatekeeper training program for the student on suicide prevention
Scientific Title
The effectiveness of the online peer gatekeeper training program for the student on suicide prevention: a randomized controlled trial
Scientific Title:Acronym
The effectiveness of the online peer gatekeeper training program for the student on suicide prevention: a randomized controlled trial
Region
| Japan |
Condition
Condition
Youth
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of a newly developed online peer gatekeeper training program for the students belonging to graduate school, university, junior college, vocational school, college of technology on self-efficacy as a gatekeeper by randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gatekeeper self-efficacy scale(GKSES)
(pre, post, 2-months follow-up)
Key secondary outcomes
-Japanese version of the short forms of Literacy of Suicide Scale
(pre, post, 2-months follow-up)
-Japanese version of the mental Illness and Disorder Understanding Scale (MIDUS)
(pre, post, 2-months follow-up)
-Scale for Measuring Help-Seeking Styles
(pre, post, 2-months follow-up)
-Psychological distress (K6)
(pre, post, 2-months follow-up)
-A Japanese version of the Rosenberg Self-esteem Scale
(pre, post, 2-months follow-up)
-Tachikawa Resilience Scale(TRS)
(pre, post, 2-months follow-up)
-University of Tokyo Health Sociology version of the SOC3 scale(SOC3-UTHS)
(pre, post, 2-months follow-up)
-Action as gatekeeper (Original)
(2-months follow-up)
-Implementation Outcome Scales for Digital Mental Health (iOSDMH) for USERs(Consumers)
(post)
-Japanese version of the Fear of COVID-19 Scale (pre)
-the Japanese version of the Compulsive Internet Use Scale (CIUS) (pre)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants assigned to the intervention group will take an online student peer gatekeeper training program within 10 days.
Interventions/Control_2
Participants who were assigned to the waitlist control group will spend usual days during the intervention period. They take the same program as those in the intervention group after the intervention period.
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.18~29 years old
2.Students belonging to graduate school, university, junior college, vocational school, college of technology
3.Those who can access the Internet via their own PC, smartphone, or tablet PC and communicate by e-mail.
4.Those who acknowledge that the program offered is a suicide prevention program.
Key exclusion criteria
1.Not read and write Japanese
2.Not full-time employees
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Miyamoto |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
yyuki@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Nozawa |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
gatekeeper.program@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation The Health Care Science Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Research Ethics Review Board of Graduate School of Medicine, the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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 | 08 | Month | 31 | 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
321
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051685
