UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044820 |
|---|---|
| Receipt number | R000051181 |
| Scientific Title | Evaluating the effectiveness of mental health literacy education for adolescents |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2023/10/01 13:14:56 |
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Basic information
Public title
Effect of mental health literacy education for adolescents
Acronym
Mental health literacy education for adolescents
Scientific Title
Evaluating the effectiveness of mental health literacy education for adolescents
Scientific Title:Acronym
Mental health literacy education for adolescents
Region
| Japan |
Condition
Condition
Mental health literacy
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of mental health literacy educational program developed for adolescents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health literacy will be assessed as follows. (1) General knowledge about mental health and illnesses will be assessed using a self-reported questionnaire (Yamaguchi et al., 2020). Each correct answer will be scored as 1 and all answers will be added up to make total score. (The wording of the questionnaire items will be modified so that junior high school students can read and understand the questions.)
(2) After reading 3 vignettes which describe 3 teenage students with depression, schizophrenia or panic disorder, the following items will be assessed, (a) "Recognition of the necessity to seek help" (b) "Intention to seek help" and (c) "Intention to help peers with the illnesses" using a self-reported questionnaire (Yamaguchi et al.,2020). Scoring methods by Yamaguchi et al., (2020) will be applied to (a)-(c). In addition to the items above, (d) stigmatizing attitudes towards each mental illness will be assessed using social distance scale (Yap et al., 2014). Also, (e) respondents will be asked to answer "What illness does each student in the vignettes suffer from?". Response options will be as follows: no illness: depression: schizophrenia: eating disorder: panic disorder: social anxiety disorder (social phobia): I don't know. Additionally, (f) respondents will be asked to answer the following: Imagine that you are having the same condition as each student in the vignettes. Would you talk to someone if you were given advice that "you had better talk to someone" from people around you? Response options will be as follows: I would: I probably would: I probably would not: I would not. ((f) was added 2022/07/30)
Each outcome will be assessed at immediately before, immediately after and 3 months after the intervention.
Yamaguchi et al., J Adolesc, 82:58-66, 2020.
Yap et al., Int J Methods Psychiatr Res, 23:49-61, 2014.
Key secondary outcomes
(1) Mental health (well-being) will be assessed using the Japanese version of the WHO-5 (Awata et al., 2007). (Total score for WHO-5 will be used.) The wording of the questionnaire items will be modified so that junior high school students can read and understand the questions.
(2) Actual help-seeking behavior for respondents' own mental health problems will be examined using self-report items.
(3) Questions about usual bedtimes and wake-up times (in the past 1-2 months) on school days and weekend days will be used to calculate Time-in-bed. The questions will be as follows: "What time (hour and minute) do you usually go to bed on school nights?" and "What time (hour and minute) do you usually wake up on school days?", and "What time (hour and minute) do you usually go to bed on weekend nights?" and "What time (hour and minute) do you usually wake up on weekends?", respectively.
Each outcome will be assessed at immediately before and 3 months after the intervention.
Awata et al., Psychiatry Clin Neurosci, 61:112-9, 2007.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
One 50-minute session regarding mental health literacy will be delivered by school teacher. Topics covered in the session will be as follows: (1) mental illnesses being common, experienced by 1 in 5 people, (2) mental health problems being closely associated with lifestyle such as sleep habits, (3) seeking help from reliable adults being a key to solving the problems, (4) knowledge about the symptoms of several mental illnesses including depression, schizophrenia, and panic disorder, and (5) skills to support peers with mental health problems.
(1)-(3) will be taught using an animated film, and (4) & (5) will be described using another animated film.(5) will also be taught through role-playing.
Interventions/Control_2
Participants in a control group will receive the session, after finishing the evaluation.
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
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students in public junior- and senior-high school.
Key exclusion criteria
None
Target sample size
2000
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
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3985
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
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3985
Homepage URL
psytokyo@yahoo.co.jp
Sponsor or person
Institute
The University of Tokyo Department of Physical and Health Education, Graduate School of Education
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
The University of Tokyo Human Research Ethics Committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033
Tel
03-5841-0643
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
| 2021 | Year | 07 | Month | 15 | 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
2671
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Statistical analysis
All analyses will be carried out on an intention-to-treat basis. In accordance with Yamaguchi et al. (2020), mixed-effects models, i.e. linear mixed models and logistic regression mixed models will be used for the analyses of continuous and dichotomous outcome variables. Mixed models are robust against missing data, that are "missing at random", in outcome variables (Bell & Fairclough, 2014).
Yamaguchi et al., J Adolesc, 82:58-66, 2020.
Bell & Fairclough, Stat Methods Med Res, 23:440-459, 2014.
Management information
Registered date
| 2021 | Year | 07 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051181
