UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056707 |
|---|---|
| Receipt number | R000064074 |
| Scientific Title | Effectiveness of Gatekeeper Training for municipal officers: A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/15 12:01:55 |
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Basic information
Public title
Effectiveness of Gatekeeper Training for municipal officers: A Non-Randomized Controlled Trial
Acronym
Evaluation of the Effectiveness of Training Materials for Suicide Prevention Gatekeepers
Scientific Title
Effectiveness of Gatekeeper Training for municipal officers: A Non-Randomized Controlled Trial
Scientific Title:Acronym
Evaluation of the Effectiveness of Training Materials for Suicide Prevention Gatekeepers
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct gatekeeper training for municipal officers and to clarify the effectiveness and sustainability of the gatekeeper training program through a non-randomized controlled trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES)
Key secondary outcomes
Knowledge required to act as a Gatekeeper
Level of preparedness to act as a Gatekeeper
The Kessler 6-item Psychological Distress Scale (K6)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants assigned to the intervention group will take part in the gatekeeper training program(75min).
Interventions/Control_2
Participants assigned to the non-intervention group will continue their normal activities during the intervention period. After this period, they will participate in the same program as the intervention group.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged between 18 and 75 years
2.Employed as municipal officer
3.Provided informed consent to participate in the study, acknowledging that the program focuses on suicide prevention
Key exclusion criteria
1.Not read and write Japanese
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Iwasawa |
Organization
Akita University
Division name
Suicide Prevention Research Center
Zip code
010-8543
Address
1-1-1 Hondou, Akita city, Akita
TEL
0188017172
iwasawa.akita.univ@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Iwasawa |
Organization
Akita University
Division name
Suicide Prevention Research Center
Zip code
0108543
Address
1-1-1 Hondou, Akita city, Akita
TEL
0188017172
Homepage URL
iwasawa.akita.univ@gmail.com
Sponsor or person
Institute
Akita university
Institute
Department
Personal name
Funding Source
Organization
None
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
Akita University
Address
1-1-1 Hondou, Akita city, Akita
Tel
0188017172
iwasawa.akita.univ@gmail.com
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
| 2025 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064074
