UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048727 |
|---|---|
| Receipt number | R000055516 |
| Scientific Title | Effect of Gatekeeper Training for Nursing College Students Using Peer Education |
| Date of disclosure of the study information | 2022/08/24 |
| Last modified on | 2023/07/11 13:57:07 |
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Basic information
Public title
Effect of Gatekeeper Training for Nursing College Students Using Peer Education
Acronym
Gatekeeper Training for Nursing College Students
Scientific Title
Effect of Gatekeeper Training for Nursing College Students Using Peer Education
Scientific Title:Acronym
Gatekeeper Training for Nursing College Students
Region
| Japan |
Condition
Condition
Suicide
Classification by specialty
| Psychiatry | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of gatekeeper training for nursing college students using peer education.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of the Literacy of Suicide Scale (LOSS-J)
Key secondary outcomes
Suicide Prevention Gatekeeper Self-Efficacy Scale (GKSES)
the Kessler 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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Gatekeeper training group
(lecture, role play)
Interventions/Control_2
Control group
(1 hour lecture video provided, free to view)
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nursing college students
Key exclusion criteria
None
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Masana |
| Middle name | |
| Last name | Ujihara |
Organization
Shukutoku University
Division name
College of Nursing and Nutrition
Zip code
2608703
Address
673 Nitona-cho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051881
masana.ujihara@soc.shukutoku.ac.jp
Public contact
Name of contact person
| 1st name | Masana |
| Middle name | |
| Last name | Ujihara |
Organization
Shukutoku University
Division name
College of Nursing and Nutrition
Zip code
2608703
Address
673 Nitona-cho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051881
Homepage URL
masana.ujihara@soc.shukutoku.ac.jp
Sponsor or person
Institute
Shukutoku University College of Nursing and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Shukutoku University
College of Nursing and Nutrition
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
Shukutoku University
Address
College of Nursing and Nutrition
Tel
0433051881
masana.ujihara@soc.shukutoku.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
| 2022 | Year | 08 | Month | 24 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055516
