UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050946 |
|---|---|
| Receipt number | R000058071 |
| Scientific Title | A study on the effect of a sexual violence prevention education program for junior and senior high school students |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/10/30 13:10:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effect of a sexual violence prevention education program for junior and senior high school students
Acronym
A study on the effect of a sexual violence prevention education program for junior and senior high school students
Scientific Title
A study on the effect of a sexual violence prevention education program for junior and senior high school students
Scientific Title:Acronym
A study on the effect of a sexual violence prevention education program for junior and senior high school students
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of sexual violence prevention education programs
Basic objectives2
Others
Basic objectives -Others
Sexual Risk Coping Awareness Scale Score
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sexual Risk Coping Awareness Scale Score
Key secondary outcomes
Knowledge of sexual violence, awareness of rape myths and secondary damage
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
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
A researcher distributes a pamphlet on sexual violence prevention to students and lets them read it for 30 minutes.
Interventions/Control_2
A researcher conducts a sexual violence prevention education program for students for one 30-minute session.
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
| 13 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students belonging to the school under study
Key exclusion criteria
If the student or their parent does not agree to participate in the research
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Emmi |
Organization
graduate school of Tsukuba
Division name
Department of Social psychiatry and Mental Health
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture General Research Building D743
TEL
0298-53-3099
seishinhoken@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Morita |
Organization
graduate school of Tsukuba
Division name
Department of Social psychiatry and Mental Health
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture General Research Building D743
TEL
0298-53-3099
Homepage URL
seishinhoken@md.tsukuba.ac.jp
Sponsor or person
Institute
graduate school of Tsukuba
Institute
Department
Personal name
Emmi Sakiko
Funding Source
Organization
Other
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
graduate school of Tsukuba
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture General Research Building D743
Tel
0298-53-3099
seishinhoken@md.tsukuba.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
| 2023 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://reg.ibmd.jp/adolescence/
Publication of results
Published
Result
URL related to results and publications
https://reg.ibmd.jp/adolescence/
Number of participants that the trial has enrolled
337
Results
Each program lasted around 20 minutes and was unidirectional. The main finding was an increased awareness of responding to sex-related risks, with no significant difference observed between the two groups. Compared to the control group, the intervention group may be less receptivity to rape myths. Furthermore, it was suggested that in both groups, males were less likely than females to seeking consultation if they were victims of sexual violence.
Results date posted
| 2025 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A cluster, non-randomized trial was conducted in July 2023 on a total of 337 students in nine classes of first-year students at public high schools in the Kanto region. A sexual violence prevention education program was implemented for a total of 188 students in five intervention classes and a total of 149 students in four control classes, and anonymous self-administered questionnaire surveys were conducted before and after the program.
Participant flow
The intervention group class received a live video of a 20-minute lecture by the first author, who used slides created for this study in a separate room at the school. The first author is an obstetrician-gynecologist with experience giving sex education lectures. The control group class received a 20-minute video of life safety education (for high schools) published on the Ministry of Education, Culture, Sports, Science and Technology website. Students watched the video projected onto a screen in each classroom from their own seats. The same questionnaire was used for both the intervention and control groups. To pair the pre- and post-program questionnaires, each questionnaire included a space for students to write their date of birth and the first hiragana character of their name. All students who attended class on the day watched each program, but students were free to decide whether or not to answer the questionnaire. The researcher provided students with an oral and written explanation of the study outline.
Adverse events
No adverse events occurred
Outcome measures
Awareness of sexual risk management, awareness of sexual violence, and impressions after the course
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058071
