UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047017 |
|---|---|
| Receipt number | R000053638 |
| Scientific Title | A Study on the Usefulness of "Mental Health Assessment" Using The Strengths and Difficulties Questionnaire (SDQ) for Junior High School Students |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2022/02/26 16:56:11 |
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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
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
tomoyuki.funatogawa@med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053638
