UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037511 |
|---|---|
| Receipt number | 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 | 2022/05/20 16:20:33 |
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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
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
otsuka@human.tsukuba.ac.jp
Sponsor or person
Institute
Faculty of Human Sciences, University of Tsukuba
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042748
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
