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 2023/04/28 02:57:13

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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

Email

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


Email

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

Email

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


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

2023 Year 04 Month 03 Day

Date of IRB


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

2023 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058071