UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042585
Receipt number R000048607
Scientific Title Verification of the effectiveness of the program on dating violence support for bystanders.
Date of disclosure of the study information 2020/11/28
Last modified on 2021/01/07 16:57:30

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Basic information

Public title

Verification of the effectiveness of the program on dating violence support for bystanders.

Acronym

Verification of the effectiveness of the program on dating violence support for bystanders.

Scientific Title

Verification of the effectiveness of the program on dating violence support for bystanders.

Scientific Title:Acronym

Verification of the effectiveness of the program on dating violence support for bystanders.

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of an educational program for Dating violence prevention for bystanders

Basic objectives2

Others

Basic objectives -Others

Examining the educational effects of dating DV prevention programs

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Supporting behavior for victims in free description is evaluated by raters
Possibility of supporting behavior is measured by using VAS before and after the program

Key secondary outcomes

View of violence is measured by using view of violence scale before and after the program
Misunderstandings about Dating violence is measured by using items of misunderstanding about dating violence


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

one lecture

Interventions/Control_2


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

15 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

high school student

Key exclusion criteria

Those who have not answered the pre-questionnaire
Those who did not answer the post-questionnaire and follw up-questionnaire
Those who declined to participate in the program

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tsunehiko
Middle name
Last name Tanaka

Organization

niigata university

Division name

faculty of education

Zip code

9502181

Address

8050 2 no-cho ikarashi nishi-ku niigata city ,Japan

TEL

025-262-5460

Email

tanakat@ed.niigata-u.ac.jp


Public contact

Name of contact person

1st name Tsunehiko
Middle name
Last name Tanaka

Organization

niigata university

Division name

faculty of education

Zip code

9502181

Address

8050 2 no-cho ikarashi nishi-ku niigata city ,Japan

TEL

025-262-5460

Homepage URL


Email

tanakat@ed.niigata-u.ac.jp


Sponsor or person

Institute

niigata university

Institute

Department

Personal name



Funding Source

Organization

not applicable

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

niigata university

Address

757 1bancho asahimachidori tyuoku niigata-city,Japan

Tel

025-227-2005

Email

joho@med.niigata-u.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

2020 Year 11 Month 28 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

199

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

2020 Year 11 Month 17 Day

Date of IRB

2020 Year 11 Month 17 Day

Anticipated trial start date

2020 Year 12 Month 02 Day

Last follow-up date

2020 Year 12 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 28 Day

Last modified on

2021 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048607


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name