UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and examination of the effects of suicide prevention education program for university students: A single-arm pilot study
Title of the study (Brief title)	Development of suicide prevention education program for university students
Region	Japan

Condition
Condition	Suicide / Self-injury
Classification by specialty	Psychiatry Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine effects of newly developed suicide prevention education program on attitudes toward suicide and help-seeking among university students.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ATTS:Attitudes Towards Suicide Scale
Key secondary outcomes	1) Inadequate Supportive Attitude towards Self-destructive behavior Scale (Original scale) 2) Trait help-seeking preferences measure 3) Expected costs/benefits of consultation scale 4) Social skills required in school scale

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	Educational program including lecture of gatekeeper training for suicide prevention and group work
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Students at University of Niigata prefecture or Niigata University
Key exclusion criteria	None
Target sample size	30

Research contact person
Name of lead principal investigator	Yotaro Katsumata
Organization	University of Niigata Prefecture
Division name	Department of Child Studies, Faculty of Human Life Studies
Address	471, Ebigase, Higashi-ku, Nigata, Japan
TEL	025-270-1300
Email	yotaro-k@unii.ac.jp

Public contact
Name of contact person	Yotaro Katsumata
Organization	University of Niigata Prefecture
Division name	Department of Child Studies, Faculty of Human Life Studies
Address	471, Ebigase, Higashi-ku, Nigata, Japan
TEL	025-270-1300
Homepage URL
Email	yotaro-k@unii.ac.jp

Sponsor
Institute	University of Niigata Prefecture
Institute
Department

Funding Source
Organization	Niigata City
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Niigata University
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 17 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2017 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028150