Teacher-led MHL Education in Japanese Preteens

NCT07116707 | Completed

• 2 other identifiers: SMHLP-JP-201915H03083
• Study Type: interventional
• Target: 1,401
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Literacy; Stigma of Mental Illness; Help-Seeking Behavior

Keywords

Mental Health Literacy; Stigma; Help-Seeking; Preteens; Elementary School Students; School-Based Intervention; Teacher-Led Program; Cluster Randomized Controlled Trial; Education Program; Japan

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)

Secondary Outcomes (4)

• 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)

Study Arms (2)

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.

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.

Interventions

Short Mental Health Literacy Program (SMHLP) BEHAVIORAL

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.

Teacher-Led Mental Health Literacy (MHL) Group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokyo University: lead

Study Sites (1)

Kanazawa Municipal Elementary Schools (8 schools)

Kanazawa, Ishikawa-ken, 920-0000, Japan

Location

MeSH Terms

Conditions

Help-Seeking Behavior; Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although classroom teachers may have been aware of group assignment, participants (students) were not informed of the study condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PhD Student), Graduate School of Education

Model Details: Cluster randomized controlled trial with school-level randomization.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 12, 2025
• Study Start: June 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data may become available beginning 6 months following publication and up to 36 months after publication, pending approval by the principal investigator.
• Access Criteria: Access to the data may be granted to qualified researchers affiliated with academic institutions for secondary analyses. Requests will be reviewed by the research team in consultation with the principal investigator to ensure ethical and legal compliance.

Locations

JP (1)