An interventional study of Short Mental Health Literacy Program (SMHLP) in Mental Health Literacy, Stigma of Mental Illness and Help-Seeking Behavior, sponsored by Tokyo University. Completed at 1 site in Japan. Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Tokyo University · Not applicable, Interventional, and Health services research
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:
Researchers will compare students who receive the program with those who follow the usual school curriculum.
Participants will:
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.
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).
105 studies on the registry are indexed under Social Stigma; 48 are open to participants now.
This study's enrollment of 1,401 is above the median of 120 across 87 interventional studies indexed under Social Stigma.
Browse Social Stigma studies →Tokyo University is the lead sponsor of 34 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
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.
Behavioral: Short Mental Health Literacy Program (SMHLP)
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.
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.
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.
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
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.
Time frame: 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".
Time frame: 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".
Time frame: 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."
Time frame: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
Plan to share: 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.
Supporting information: Sap
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Help-Seeking Behavior
Tokyo University