UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058909 |
|---|---|
| Receipt number | R000067369 |
| Scientific Title | Effectiveness of a Sexual Violence Prevention Bystander Intervention Training Program for University Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/23 18:24:06 |
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Basic information
Public title
Evaluation of a Sexual Violence Prevention Bystander Intervention Training for University Students
Acronym
Evaluation of a Sexual Violence Prevention Bystander Intervention Training
Scientific Title
Effectiveness of a Sexual Violence Prevention Bystander Intervention Training Program for University Students: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of a Sexual Violence Prevention Bystander Intervention Training Program: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
University student
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a bystander intervention training program for the prevention of sexual violence among university students and to evaluate its effectiveness through a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in total score of the Bystander Efficacy Scale
Key secondary outcomes
Change in total score of the Rape Myth Acceptance Scale
Change in total score of the social norms
Change in total score of the engagement in the training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
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
Viewing of video educational material and reading ofwritten educational material
Interventions/Control_2
Reading of written educational material
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
University student
Key exclusion criteria
Graduate students, Individuals with visual or hearing impairments, Individuals unable to read or write Japanese,Individuals without Internet access
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Fujioka |
Organization
Ibaraki Prefectural University of Health
Division name
School of Health Sciences Department of Nursing
Zip code
300-0394
Address
4669-2 Oaza Ami, Ami-machi, Inashiki-gun, Ibaraki-ken, Japan
TEL
029-888-4000
fujiokah@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yamamoto |
Organization
Ibaraki Prefectural University of Health
Division name
School of Health Sciences Department of Nursing
Zip code
300-0394
Address
School of Health Sciences Department of Nursing
TEL
029-840-2221
Homepage URL
yamamotoju@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health
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
Teikyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Ibaraki Prefectural University of Health Sciences
Address
4669-2 Oaza Ami, Ami-machi, Inashiki-gun, Ibaraki-ken, Japan
Tel
029-888-4000
kyoumu@ipu.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
| 2025 | Year | 10 | Month | 17 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | 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 | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067369
