UMIN-CTR Clinical Trial

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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