UMIN-CTR Clinical Trial

Basic information
Public title	Application of Mental Health First Aid to school nurse:pilot study
Acronym	Application of Mental Health First Aid to school nurse
Scientific Title	Application of Mental Health First Aid to school nurse:pilot study
Scientific Title:Acronym	Application of Mental Health First Aid to school nurse
Region	Japan

Condition
Condition	Depression and suicide related behaviors
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of a brief structured training program based on Mental Health First Aid to increase knowledge and skills for school nurse to deal with person with depression and suicidal thoughts
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The change of score of questionnaire asking knowledge, skills and confidence to deal with person with depression and suicidal thoughts at just before, just after and one month later the intervention
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Mental Health First Aid (MHFA) program including lecture and role playing
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	school nurse given written informed consents on this study
Key exclusion criteria	none
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Kato
Organization	Kyushu University
Division name	Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL	092-642-5627
Email	takahiro@npsych.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Kato
Organization	Kyushu University
Division name	Department of Neuropsychiatry Graduate School of Medical Sciences
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL	092-642-5627
Homepage URL
Email	takahiro@npsych.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Grant for clinical cancer research from the Ministry of Health, Labour and Welfare, Japan (Japan Agency for Medical Research and Development: AMED)
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	IRB of Kyushu University
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
Tel	092-642-5082
Email	bynintei@jimu.kyushu-u.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	2018 Year 04 Month 01 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	94
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	2018 Year 01 Month 22 Day
Date of IRB	2018 Year 07 Month 19 Day
Anticipated trial start date	2018 Year 07 Month 20 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 02 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036029