UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Usefulness of "Mental Health Assessment" Using The Strengths and Difficulties Questionnaire (SDQ) in Junior High Schools
Acronym	A Study on the Usefulness of "Mental Health Examination" in Junior High Schools
Scientific Title	A Study on the Usefulness of "Mental Health Assessment" Using The Strengths and Difficulties Questionnaire (SDQ) for Junior High School Students
Scientific Title:Acronym	A Study on the Usefulness of "Mental Health Examination" Using SDQ for Junior High School Students
Region	Japan

Condition
Condition	emotional problems, conduct problems, hyperactivity, peer problems, prosocial behavior
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate whether teachers' use of the Japanese version of the Strength and Difficulties Questionnaire to assess and understand the psychological problems of junior high school students is helpful in discussing how to deal with their students' psychological problems.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in teachers' subjective evaluations of the " mental health assessment" for students before, after, and three months after the assessment.
Key secondary outcomes	Changes in teachers' mental health literacy (MHL scale on children) toward students assessed before, after, and three months after the "mental health assessment" for their students.

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	Based on the results of each student's SDQ, teachers receive advice from child psychiatrists and clinical psychologists on how to deal with each student's psychological problems.
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	12 years-old <=
Age-upper limit	14 years-old >=
Gender	Male and Female
Key inclusion criteria	First- or second-year junior high school students attending regular classes at public junior high schools in Ota Ward, Tokyo, who have obtained consent from their school principal to participate in this study.
Key exclusion criteria	Students whose consent to participate in this study was not obtained from them or their parents.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Nemoto
Organization	Toho university Faculty of Mediane, Tokyo, Japan
Division name	Department of Neuropsychiatry
Zip code	143-8541
Address	6-11-1,Omori-nishi, Ota-ku, Tokyo
TEL	0337624151
Email	takahiro.nemoto@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Tomoyuki Middle name Last name Funatogawa
Organization	Toho university Faculty of Mediane, Tokyo, Japan
Division name	Department of Neuropsychiatry
Zip code	143-8541
Address	6-11-1,Omori-nishi, Ota-ku, Tokyo
TEL	0337624151
Homepage URL
Email	tomoyuki.funatogawa@med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
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	the Ethical Research Committee of Toho University Faculty of Medicine
Address	5-21-16,Omori-nishi,Ota-ku,Tokyo
Tel	0337624151
Email	med.rinri@ext.toho-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	2022 Year 02 Month 28 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	Open public recruiting
Date of protocol fixation	2018 Year 12 Month 12 Day
Date of IRB	2018 Year 12 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 10 Day
Last follow-up date	2024 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	2022 Year 02 Month 26 Day
Last modified on	2022 Year 02 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053638