UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041397 |
|---|---|
| Receipt number | R000047260 |
| Scientific Title | Effectiveness of a Comprehensive Mental Health Literacy Educational Programme for Junior High School Students:A Randomised Controlled Trial Examining Changes in Their Knowledge, Attitudes, and Behaviour |
| Date of disclosure of the study information | 2020/08/25 |
| Last modified on | 2023/03/11 18:18:13 |
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Basic information
Public title
Effectiveness of a Comprehensive Mental Health Literacy Educational Programme for Junior High School Students:A Randomised Controlled Trial Examining Changes in Their Knowledge, Attitudes, and Behaviour
Acronym
Effectiveness of a Comprehensive Mental Health Literacy Educational Programme for Junior High School Students:A Randomised Controlled Trial Examining Changes in Their Knowledge, Attitudes, and Behaviour
Scientific Title
Effectiveness of a Comprehensive Mental Health Literacy Educational Programme for Junior High School Students:A Randomised Controlled Trial Examining Changes in Their Knowledge, Attitudes, and Behaviour
Scientific Title:Acronym
Randomized controlled trial
Region
| Japan |
Condition
Condition
General population
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mental health literacy education targeting junior high school students in Japan would have significantly more improvement in help-seeking behaviour for mental health problems compared to the regular health education provided in Japanese school education. Contents of mental health literacy includes knowledge of the mental illness, how to deal with them, and how to reduce the stigma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the proportion of students who have a help-seeking behaviour related to mental health problems from the baseline to 3 months after the intervention.Question of primary outcomes: "Did you consult with someone about mental illness in the past 3 months?"
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Face-to-face lessons about mental health and illness and how to deal with them.
Interventions/Control_2
Divide into two groups: a group that provides education on mental illness (3 classes of 50 minutes) and a group that provides regular classes.Regarding the knowledge, attitude, and behavior of mental illness, changes in scores before and after the lesson and three months after the lesson are compared between groups.
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
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Junior high school student of 1st grade (12 to 13 years old)
Key exclusion criteria
Those who are unable to read and write in Japanese equivalent to the graduation of elementary school in Japan.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nemoto |
Organization
Toho University
Division name
School of medicine
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
takahiro.nemoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Mori |
Organization
Toho University
Division name
School of medicine
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
morir@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Toho University
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
Toho University
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
0337624151
takahiro.nemoto@med.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
| 2020 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
https://doi.org/10.3390/jpm12081281
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3390/jpm12081281
Number of participants that the trial has enrolled
116
Results
Regarding MIDUS, the post-test and 3-month follow-up test results showed a significant main effect of time by-group interactions in a linear mixed model. Regarding RIBS-J, the post-test results showed a significant main effect of time-by-group interactions; however, the 3-month follow-up test showed no significant effect. No significant effects of time-by-group interactions were seen in the post-test and 3-month follow-up test results for help-seeking behaviour in a logistic regression-mixed model.
Results date posted
| 2022 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects consisted of 156 first-year students attending a public junior high school (aged 12 to 13 years; Grade 7; Year 8) in Tochigi, Japan. The choice of school was based on the availability of study cooperation and the feasibility of the intervention. Of these, 125 consented to participate in the study and were randomly allocated to the intervention group (n = 51) or the control group (n = 74). The final number of participants included in the analysis was 116 (50 in the intervention group and 66 in the control group). There were 25 males and 25 females in the intervention group and 30 males and 36 females in the control group.
Participant flow
The subjects consisted of 156 first-year students attending a public junior high school (aged 12 to 13 years; Grade 7; Year 8) in Tochigi, Japan. The choice of school was based on the availability of study cooperation and the feasibility of the intervention. The exclusion criteria were those who could not read or write Japanese at a level equivalent to that of a Japanese primary school graduate. Participants in the study provided written consent from both the subjects themselves and their parent or guardian. Of these, 125 consented to participate in the study and were randomly allocated to the intervention group (n = 51) or the control group (n = 74). After excluding those who were absent from the classes or did not complete the assessments, the final number of participants included in the analysis was 116 (50 in the intervention group and 66 in the control group).
Adverse events
None.
Outcome measures
There was a significant main effect of time and time-by-group interaction in the MIDUS post-test (B [95% CI] main effect of time = -8.40 [-10.07, -6.73], p<0.001, time x group interaction p = 7.36 [5.14, 9.57], <0.001) and the 3-month follow-up (B [95% CI] main effect of time = -6.14 [-7.81, -4.47], p<0.001, time x group interaction p = 4.19 [1.97, 6.41], <0.001).
There was a significant main effect of time and time-by-group interaction in the RIBS-J future post-test (B [95% CI] main effect of time = 2.20 [1.45, 2.96], p<0.001, time x group interaction p = -1.85 [-2.85, -0.85], <0.001). There was a no significant effect of time-by-group interaction the 3-month follow-up (B [95% CI] main effect of time = 1.84 [1.85, 2.60], p<0.001, time x group interaction p = -0.72 [-1.72, 0.28], p = 0.158).
There were no significant main effects of time or time-by-group interaction in either the post-test or the 3-month follow-up questionnaire results for help-seeking behaviour.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047260
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