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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037511
Receipt No. R000042748
Scientific Title An intervention study to reduce homophobia and transphobia among workers: a randomized controlled trial
Date of disclosure of the study information 2019/07/28
Last modified on 2019/10/24

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Basic information
Public title An intervention study to promote appropriate response to sexual minorities
Acronym An intervention study to promote appropriate response to sexual minorities
Scientific Title An intervention study to reduce homophobia and transphobia among workers: a randomized controlled trial
Scientific Title:Acronym An intervention study to reduce homophobia and transphobia
Region
Japan

Condition
Condition No applicable
Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of an intervention program to promote appropriate supports to sexual minority workers among occupational health, human resource, diversity promotion, or managerial staff on homophobia and transphobia, by comparison with the group without intervention. We also aim to examine the effectiveness of the intervention program on improving the knowledge about sexual minorities and the level of confidence to support them appropriately.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Homophobia and transphobia (before randomization, at the end of the second intervention, at the end of the fourth intervention, and one month after the intervention).
Homophobia and transphobia will be measured by Implicit Positive and Negative Affect Test (IPANAT), Index of Homophobia (IHP), and Transphobia Scale.
Key secondary outcomes 1) Knowledge of sexual minorities
2) Level of confidence to support sexual minorities
These outcomes will be measured at the end of the second intervention, at the end of the fourth intervention, and one month after the intervention.
3) Implementation of action plan, which will be measured at one month after the intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 A total of 11 hours, 4 times, 1-month intervention program. This program consists of improving knowledge about sexual minorities, harassment, homophobia, and transphobia, talks of the parties, role-playing about how to conduct a counseling for them, case studies of corporate activities, and action planning at the affiliation.
Interventions/Control_2 Wait list control condition
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

Not applicable
Gender Male and Female
Key inclusion criteria Occupational health, human resource, diversity promotion, or managerial staff
Key exclusion criteria None
Target sample size 66

Research contact person
Name of lead principal investigator
1st name Yasumasa
Middle name
Last name Otsuka
Organization University of Tsukuba
Division name Faculty of Human Sciences
Zip code 1120012
Address 3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
TEL +81-3-3942-6852
Email otsuka@human.tsukuba.ac.jp

Public contact
Name of contact person
1st name Yasumasa
Middle name
Last name Otsuka
Organization University of Tsukuba
Division name Faculty of Human Sciences
Zip code 1120012
Address 3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
TEL +81-3-3942-6852
Homepage URL
Email otsuka@human.tsukuba.ac.jp

Sponsor
Institute Faculty of Human Sciences, University of Tsukuba
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Sciences (JSPS)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of the Faculty of Human Sciences, Tokyo Branch, University of Tsukuba
Address 3-29-1 Otsuka, Bunkyo-ku, Tokyo, Japan
Tel +81-3-3942-6919
Email hitorinri@un.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
2019 Year 07 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
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 No longer recruiting
Date of protocol fixation
2019 Year 07 Month 28 Day
Date of IRB
2019 Year 07 Month 26 Day
Anticipated trial start date
2019 Year 07 Month 28 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 07 Month 27 Day
Last modified on
2019 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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