UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025851 |
|---|---|
| Receipt number | R000029727 |
| Scientific Title | Efficacy of the seminar of capacity development based on Psychological First Aid for Schools |
| Date of disclosure of the study information | 2017/01/26 |
| Last modified on | 2018/07/28 12:42:47 |
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Basic information
Public title
Efficacy of the seminar of capacity development based on Psychological First Aid for Schools
Acronym
Efficacy of Psychological First Aid for Schools
Scientific Title
Efficacy of the seminar of capacity development based on Psychological First Aid for Schools
Scientific Title:Acronym
Efficacy of Psychological First Aid for Schools
Region
| Japan |
Condition
Condition
Not Applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether one day psychological first aid for schools seminar improves educational personnel's ability to take mental care of students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of eight core actions described in Psychological First aid field operation manual.
Assessment will be done before the seminar and 1 month after the seminar.
Key secondary outcomes
1.Self confidence of taking mental care for students among educational personnel.
2.Psychological stress reaction among educational personnel measured by K-6.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
One day seminar of Psychological First Aid for Schools, which will last 6 hours.
Interventions/Control_2
waiting list
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
Educational personnel who works for primary, secondary, and high school 5 days a week.
Key exclusion criteria
those who do not participated in the seminar after registration
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eizaburo Tanaka |
Organization
Hyogo Institute for Traumatic Stress
Division name
Laboratory 1
Zip code
Address
1-3-2, Wakinohama-kaigandori, Chuo-ku, Kobe
TEL
0782003010
Eizaburo_Tanaka@j-hits.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eizaburo Tanaka |
Organization
Hyogo Institute for Traumatic Stress
Division name
Laboratory 1
Zip code
Address
1-3-2, Wakinohama-kaigandori, Chuo-ku, Kobe
TEL
0782003010
Homepage URL
Eizaburo_Tanaka@j-hits.org
Sponsor or person
Institute
Hyogo Institute for Traumatic Stress
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
兵庫県こころのケアセンター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 26 | 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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029727
