UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027863 |
|---|---|
| Receipt number | 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 12:02:36 |
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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
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
mamikiri@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031925
