UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051367 |
|---|---|
| Receipt number | R000058604 |
| Scientific Title | Study of the safety and efficacy of mental health screening early detect and deal with mental illness and suicide risk in adolescents |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/08/01 09:06:52 |
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Basic information
Public title
Study on early detection of mental illness and suicide risk in adolescents
Acronym
Study on early detection of mental illness and suicide risk in adolescents
Scientific Title
Study of the safety and efficacy of mental health screening early detect and deal with mental illness and suicide risk in adolescents
Scientific Title:Acronym
Study of the safety and efficacy of mental health screening early detect and deal with mental illness and suicide risk in adolescents
Region
| Japan |
Condition
Condition
Mental health problems
Risk of suicide
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study whether teachers' asking children about suicidal risks improves/affect their mental health and suicidal ideation.
Also studying whether mental health screening in adolescents by schoolteachers promotes early detection and helping children's mental illness and their suicide risk.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To study the effects of teachers directly asking children about their risk of suicide on children's mental health and suicidal ideation.
In addition, a questionnaire survey will be conducted to evaluate the psychological burden on teachers and children when mental health screening is delivered/taken at schools.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Junior- and senior-high school students who are above the cutoff in screening for mental health or suicidal ideation will be cluster (school or class)-randomly assigned into two groups (Groups A and B).
On their mental health and suicidal ideation,
Students in Group A will be asked about suicide risk, in addition to sleep and appetite, in semi-structured interviews by teachers. Then, mental health and suicide ideation will be re-assessed using the same questionnaire for the initial screening, in those students.
Interventions/Control_2
Students in Group B will be asked about sleep and appetite, not about suicide risk, in semi-structured interviews by teachers. Then, mental health and suicidal ideation will be re-assessed in the same manner as Group A.
Change in mental health and suicidal ideation will be compared between the two groups, in order to examine the effects of the teachers' asking children about suicide risk.
After the examination, students in Group B will also be asked about their suicide risk in the same manner as Group A.
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
| 19 | years-old | > |
Gender
Male and Female
Key inclusion criteria
student of junior high school or high school.
Key exclusion criteria
None
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Sasaki |
Organization
the University of Tokyo
Division name
Department of Physical and Health Education, Graduate School of Education
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL
0358413985
psytokyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Sasaki |
Organization
The University of Tokyo
Division name
Department of Physical and Health Education, Graduate School of Education
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
TEL
0358413985
Homepage URL
psytokyo@yahoo.co.jp
Sponsor or person
Institute
Department of Physical and Health Education, Graduate School of Education, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Committee of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-Ku, Tokyo
Tel
0358410284
lifescience.adm@gs.mail.u-tokyo.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
| 2023 | Year | 06 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058604
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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