Pilot Cluster RCT of an Indirect Contact Mental Health Literacy Program for 5th-Grade Students (SMHLP-IC)

Tokyo University

Status: Not yet enrolling

Conditions: Help-seeking Intention; Mental Health Literacy; Stigma (Social Distance)

Treatments: Behavioral: Standard MHL Lesson Only; Behavioral: Indirect Contact

Study type: Interventional

Funder types: Other

Identifiers

NCT07324265

SMHLP-IC-2025

Details and patient eligibility

About

This cluster-randomized pilot trial will evaluate the preliminary effects and feasibility of adding an indirect contact component to a school-based mental health literacy (MHL) lesson for 5th-grade students in a public elementary school in Tokyo, Japan. Four 5th-grade classes (approximately 150 students in total) will be randomized by class (two classes per arm). All students will receive a 45-minute lesson that includes an animated video and educational slides. In the intervention arm, teachers will additionally introduce a short story about a well-known soccer player who experienced and recovered from a mental health condition, serving as an indirect contact element. The control arm will receive the standard lesson without this component.

Students will complete questionnaires at baseline (T1), immediately after the lesson (T2), and 2-3 months later (T3). The primary outcome is vignette-based social distance toward a peer with mental health problems. Secondary outcomes include mental health knowledge, help-seeking intentions, perceived need for help, intended sources of help. As a pilot study with only four clusters, the trial is not powered to detect small effects; findings will be used to estimate effect sizes and assess feasibility for a future larger-scale trial.

Full description

This study investigates whether incorporating an indirect contact component into an existing school-based mental health literacy (MHL) program enhances reductions in stigma-specifically vignette-based social distance-among elementary school students. Indirect contact is implemented through a teacher-delivered story describing the lived experience and recovery of a well-known soccer player who publicly disclosed his mental illness. This approach aims to promote empathy, reduce negative stereotypes, and strengthen intentions to seek or recommend appropriate help.

The study uses a cluster-randomized parallel-group design, with four 5th-grade classes assigned (2:2) to either the intervention or control condition. Both groups receive a standardized 45-minute MHL lesson including an animated educational video and discussion materials. The intervention arm additionally receives the indirect contact component within the same 45-minute period. The lesson is delivered by classroom teachers.

Assessments occur at three time points:

• T1 (baseline): before the lesson
• T2 (post-test): immediately after the lesson
• T3 (follow-up): 2-3 months after the lesson

The primary outcome is a 5-item social distance scale based on a vignette ("A-san") describing symptoms consistent with depression. Secondary outcomes include:

• mental health knowledge
• intentions to support a friend with similar problems
• perceived need for help
• personal help-seeking intentions
• intended help-seeking sources

Because this is a pilot trial, the goals are to evaluate feasibility (recruitment, retention, acceptability, implementation fidelity) and to estimate preliminary effect sizes to inform sample size calculations for a future fully powered cluster randomized trial. After T3 data collection, students in the control arm will be offered an educational supplement that includes the indirect contact story.

Enrollment: 150 estimated patients

Sex: All

Ages: 10 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Students enrolled in 5th grade at one of the eight participating public elementary schools in Kanazawa, Japan.
• Aged 10-11 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Indirect Contact

Experimental group

Description:

A 45-minute school-based mental health literacy lesson that includes an animated video, educational slides, and an additional indirect contact component. The indirect contact consists of a teacher-delivered story about a well-known soccer player who experienced and recovered from a mental health condition.

Treatment:

Behavioral: Indirect Contact

Standard MHL Lesson Only

Active Comparator group

Description:

A 45-minute standard mental health literacy lesson that includes an animated educational video and slides. This lesson does not include the indirect contact story component.

Treatment:

Behavioral: Standard MHL Lesson Only