UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of the seminar of capacity development based on Psychological First Aid for Schools
Title of the study (Brief title)	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	Eizaburo Tanaka
Organization	Hyogo Institute for Traumatic Stress
Division name	Laboratory 1
Address	1-3-2, Wakinohama-kaigandori, Chuo-ku, Kobe
TEL	0782003010
Email	Eizaburo_Tanaka@j-hits.org

Public contact
Name of contact person	Eizaburo Tanaka
Organization	Hyogo Institute for Traumatic Stress
Division name	Laboratory 1
Address	1-3-2, Wakinohama-kaigandori, Chuo-ku, Kobe
TEL	0782003010
Homepage URL
Email	Eizaburo_Tanaka@j-hits.org

Sponsor
Institute	Hyogo Institute for Traumatic Stress
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029727