Effectiveness of Teacher-led Mental Health Literacy Programs on Knowledge, Stigma, and Help-seeking in Preteens: A Cluster Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,401
- Locations
- 1
- Primary Endpoint
- Mental Health Knowledge Score
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
Although classroom teachers may have been aware of group assignment, participants (students) were not informed of the study condition.
Eligibility Criteria
- Ages
- 10 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Teacher-Led Mental Health Literacy (MHL) Group
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.
Intervention: Short Mental Health Literacy Program (SMHLP) (Behavioral)
Waitlist Control Group
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Social Distance Scale Score (Stigma)(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Help-Seeking Intention(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Recognition of the necessity to seek help(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Intention to Help Peers(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
Investigators
Nobuko Demura
Principal Investigator (PhD Student), Graduate School of Education
Tokyo University