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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027863
Receipt No. R000031925
Scientific Title Evaluation of an Educational Program for Youths mental health Supporters
Date of disclosure of the study information 2017/06/22
Last modified on 2017/06/22

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Basic information
Public title Evaluation of an Educational Program for Youths mental health Supporters
Acronym Evaluation of SSLRT using Quasi RCT
Scientific Title Evaluation of an Educational Program for Youths mental health Supporters
Scientific Title:Acronym Evaluation of SSLRT using Quasi RCT
Region
Japan

Condition
Condition N/A
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Through Quasi RCT design, we evaluate SSLRT program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The number of being consulted in the last one month
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 SSLRT
Interventions/Control_2 no intervension
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
20 years-old <
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria - participant of SSLRT
- ability to communicate in Japanese
- 20 years or over
- can make consent in writing
Key exclusion criteria - not a participant of SSLRT
- ability to communicate in Japanese
- 20 years or over
- can make consent in writing
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mami Kiritani
Organization Kyouto University Hospital
Division name Department of Ethics Support
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto-si
TEL 075-753-9470
Email mamikiri@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MAMI KIRITANI
Organization Kyouto University Hospital
Division name Department of Ethics Support
Zip code
Address Yoshida Konoe-cho, Sakyo-ku, Kyoto-si
TEL 075-753-9470
Homepage URL
Email mamikiri@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Mnistry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 京都大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 22 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
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 22 Day
Last modified on
2017 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031925

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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