Mental Health LiteracySMHLPNCT07116707
Teacher-led MHL Education in Japanese Preteens
A study testing Short Mental Health Literacy Program (SMHLP) in people with Mental Health Literacy and Stigma of Mental Illness, run by Tokyo University at 1 site in Japan.
Trial summary
The goal of this clinical trial is to learn whether a short, teacher-delivered mental health literacy (MHL) program can help improve mental health knowledge, reduce stigma, and encourage help-seeking among preteens in Japan. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Literacy, Stigma of Mental Illness, Help-Seeking Behavior
- What is being tested?
- Short Mental Health Literacy Program (SMHLP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,401 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in 5th or 6th grade at one of the eight participating public elementary schools in Kanazawa, Japan.
- Aged 10-12 years old.
- Passive consent obtained from guardians; verbal assent obtained from children.
- Able to complete self-report questionnaires.
Who cannot join
- Students whose parents/guardians opted out of the study.
- Note: Students who were absent on the day of the pre-test (T1) were excluded from the analysis population but not from the initial study cohort.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kanazawa Municipal Elementary Schools (8 schools)
Kanazawa, Ishikawa-ken, 920-0000
About this study
Official title: Effectiveness of Teacher-led Mental Health Literacy Programs on Knowledge, Stigma, and Help-seeking in Preteens: A Cluster Randomized Controlled Trial
The goal of this clinical trial is to learn whether a short, teacher-delivered mental health literacy (MHL) program can help improve mental health knowledge, reduce stigma, and encourage help-seeking among preteens in Japan. Participants are students in grade 5 (age 10-11) and grade 6 (age 11-12) attending public elementary schools.
The main questions this study aims to answer are:
Read more
- Does the program increase students' knowledge about mental health and illnesses?
- Does it reduce stigma toward people with mental illnesses?
- Does it increase willingness to seek help and support peers?
Researchers will compare students who receive the program with those who follow the usual school curriculum.
Participants will:
- Answer short self-report questionnaires before, right after, and three months after the program
- Learn through a 45-minute classroom session that includes slides, a short animated film, and review activities
- Be part of regular school classes led by their homeroom teacher
The goal is to understand whether a concise and scalable MHL education can support early mental health awareness and prevention in younger youth.
The results may help schools provide effective mental health education at an early age.
Read the detailed description
This study used a cluster randomized controlled trial design, with randomization at the school level. Eight public elementary schools in Kanazawa City were assigned to either intervention or control groups using simple randomization by external staff not involved in implementation.
The intervention, the Short Mental Health Literacy Program (SMHLP), consisted of a 45-minute classroom lesson delivered by homeroom teachers. The lesson included three parts: a slide-based introduction to mental health, a 10-minute original animation about a student experiencing psychological stress, and a worksheet-based reflection activity. Teachers used self-guided materials including videos and manuals to prepare.
Primary outcome measures included an 8-item true/false knowledge scale (range: 0-8), a 5-item social distance scale (range: 5-20), and binary-response questions on help-seeking intention and willingness to support peers. The internal consistency of the knowledge scale was acceptable (Cronbach's α = 0.65), and that of the stigma scale was good (Cronbach's α = 0.88).
Data were collected at three time points: before the intervention (T1), immediately after (T2), and three months later (T3). Statistical analyses were conducted using linear mixed models (LMM) for continuous outcomes and logistic regression mixed models (LRMM) for binary outcomes. Three-level hierarchical structures were modeled for LMM, with time nested within students and students nested within schools. School-level clustering was adopted. For LRMMs, two-level models were used without random effects for schools due to convergence issues. Intention-to-treat analyses were conducted. Subgroup analyses were performed by grade level.
Parental opt-out consent procedures were used, and verbal assent was obtained from students. The study was approved by the University of Tokyo Human Research Ethics Committee (Approval No. 15-118).
- Being tested
- Short Mental Health Literacy Program (SMHLP)
- Keywords
- Mental Health Literacy, Stigma, Help-Seeking, Preteens, Elementary School Students, School-Based Intervention, Teacher-Led Program, Cluster Randomized Controlled Trial, Education Program, Japan
- Medical subject headings
- Help-Seeking Behavior, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Mental Health Literacy Program (SMHLP)Behavioural
A single 45-minute behavioral health education lesson delivered by homeroom teachers. The session included a slide-based introduction to mental health, a 10-minute animated video about a student experiencing psychological stress, and a worksheet-based reflection activity. Teachers prepared using self-guided materials.
| Study group | Role | What they receive |
|---|---|---|
| Teacher-Led Mental Health Literacy (MHL) Group | Experimental | Students in this group received a 45-minute mental health literacy (MHL) lesson led by their homeroom teacher. The session included three components: a slide-based introduction to mental health, a 10-minute animated video showing a student experiencing psychological stress, and a reflection activity using a worksheet. Teachers prepared for the lesson using self-guided materials, including a manual and instructional videos. Receives: Behavioral: Short Mental Health Literacy Program (SMHLP) |
| Waitlist Control Group | No intervention | Students in this group received the standard school curriculum and did not receive the mental health literacy (MHL) lesson during the study period. The MHL lesson was provided to this group after the follow-up data collection for ethical reasons, but the post-lesson data were not included in the analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Knowledge Score
An 8-item true/false questionnaire developed based on the SMHLP content. Scores range from 0 to 8, with higher scores indicating greater knowledge about mental health and illnesses. Cronbach's alpha was 0.65.
Measured: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Secondary outcomes (4)
Social Distance Scale Score (Stigma)
A 5-item scale adapted from the Social Distance Scale using a vignette format. Each item rated on a 4-point scale (1=definitely willing to 4=definitely unwilling), total score range 4-20. Higher scores indicate greater stigma. Cronbach's alpha was 0.88.
Measured: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Help-Seeking Intention
A vignette-based item asking whether students themselves would seek help if they were experiencing similar mental health difficulties. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to have the intention to seek help if they responded "Definitely yes".
Measured: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Recognition of the necessity to seek help
A single vignette-based item asking whether students thought the character in the scenario should seek help from others. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to recognize the necessity to seek help when they responded "Definitely yes".
Measured: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Intention to Help Peers
Students were asked to rate their likelihood of performing various desirable supportive behaviors for a peer in distress. Each item was rated on a 4-point scale. Students were considered to have the intention to help if they selected "Definitely yes" for at least one of the behaviors. An example of a behavior is: "I would ask about or listen to their story to understand their situation in detail."
Measured: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jun 2019
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial with school-level randomization.
- Masking
- None (open label)
- Enrolment
- 1,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuko Demura, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116707
- Sponsor's protocol ID
- SMHLP-JP-2019
- Other IDs
- 15H03083
- Acronym
- SMHLP
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be made available upon request. The final decision on data sharing will be made in consultation with the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Teacher-led Mental Health Literacy Programs on Knowledge, Stigma, and Help-seeking in Preteens: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07116707
- Acronym / sponsor ID
- SMHLP / SMHLP-JP-2019
- Keywords
- Mental Health Literacy, Stigma, Help-Seeking, Preteens, Elementary School Students, School-Based Intervention, Teacher-Led Program, Cluster Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,401 participants (actual)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a short, teacher-delivered mental health literacy (MHL) program can help improve mental health knowledge, reduce stigma, and encourage help-seeking among preteens in Japan. Participants are students in grade 5 (age 10-11) and grade 6 (age 11-12) attending public elementary schools.
The main questions this study aims to answer are:
- Does the program increase students' knowledge about mental health and illnesses?
- Does it reduce stigma toward people with mental illnesses?
- Does it increase willingness to seek help and support peers?
Researchers will compare students who receive the program with those who follow the usual school curriculum.
Participants will:
- Answer short self-report questionnaires before, right after, and three months after the program
- Learn through a 45-minute classroom session that includes slides, a short animated film, and review activities
- Be part of regular school classes led by their homeroom teacher
The goal is to understand whether a concise and scalable MHL education can support early mental health awareness and prevention in younger youth.
The results may help schools provide effective mental health education at an early age.
Detailed description
This study used a cluster randomized controlled trial design, with randomization at the school level. Eight public elementary schools in Kanazawa City were assigned to either intervention or control groups using simple randomization by external staff not involved in implementation.
The intervention, the Short Mental Health Literacy Program (SMHLP), consisted of a 45-minute classroom lesson delivered by homeroom teachers. The lesson included three parts: a slide-based introduction to mental health, a 10-minute original animation about a student experiencing psychological stress, and a worksheet-based reflection activity. Teachers used self-guided materials including videos and manuals to prepare.
Primary outcome measures included an 8-item true/false knowledge scale (range: 0-8), a 5-item social distance scale (range: 5-20), and binary-response questions on help-seeking intention and willingness to support peers. The internal consistency of the knowledge scale was acceptable (Cronbach's α = 0.65), and that of the stigma scale was good (Cronbach's α = 0.88).
Data were collected at three time points: before the intervention (T1), immediately after (T2), and three months later (T3). Statistical analyses were conducted using linear mixed models (LMM) for continuous outcomes and logistic regression mixed models (LRMM) for binary outcomes. Three-level hierarchical structures were modeled for LMM, with time nested within students and students nested within schools. School-level clustering was adopted. For LRMMs, two-level models were used without random effects for schools due to convergence issues. Intention-to-treat analyses were conducted. Subgroup analyses were performed by grade level.
Parental opt-out consent procedures were used, and verbal assent was obtained from students. The study was approved by the University of Tokyo Human Research Ethics Committee (Approval No. 15-118).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial with school-level randomization.
| Arm | Type | Receives |
|---|---|---|
| Teacher-Led Mental Health Literacy (MHL) Group | Experimental | Behavioral: Short Mental Health Literacy Program (SMHLP)Students in this group received a 45-minute mental health literacy (MHL) lesson led by their homeroom teacher. The session included three components: a slide-based introduction to mental health, a 10-minute animated video showing a student experiencing psychological stress, and a reflection activity using a worksheet. Teachers prepared for the lesson using self-guided materials, including a manual and instructional videos. |
| Waitlist Control Group | No intervention | –Students in this group received the standard school curriculum and did not receive the mental health literacy (MHL) lesson during the study period. The MHL lesson was provided to this group after the follow-up data collection for ethical reasons, but the post-lesson data were not included in the analysis. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students enrolled in 5th or 6th grade at one of the eight participating public elementary schools in Kanazawa, Japan.
- Aged 10-12 years old.
- Passive consent obtained from guardians; verbal assent obtained from children.
- Able to complete self-report questionnaires.
Key exclusion criteria (2 listed)
- Students whose parents/guardians opted out of the study.
- Note: Students who were absent on the day of the pre-test (T1) were excluded from the analysis population but not from the initial study cohort.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Mental Health Literacy Program (SMHLP)A single 45-minute behavioral health education lesson delivered by homeroom teachers. The session included a slide-based introduction to mental health, a 10-minute animated video about a student experiencing psychological stress, and a worksheet-based reflection activity. Teachers prepared using self-guided materials. | Behavioural | Teacher-Led Mental Health Literacy (MHL) Group |
Primary outcome
Mental Health Knowledge Score
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
An 8-item true/false questionnaire developed based on the SMHLP content. Scores range from 0 to 8, with higher scores indicating greater knowledge about mental health and illnesses. Cronbach's alpha was 0.65.
4 secondary outcomes
Social Distance Scale Score (Stigma)
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Help-Seeking Intention
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Recognition of the necessity to seek help
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Intention to Help Peers
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Yes. De-identified data may be made available upon request. The final decision on data sharing will be made in consultation with the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Mental Health Literacy Program (SMHLP) in people with Mental Health Literacy and Stigma of Mental Illness, run by Tokyo University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Knowledge Score (time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.