NCT07324265

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

A Cluster-Randomized Pilot Trial of a School-Based Mental Health Literacy Program With and Without an Indirect Contact Component for 5th-Grade Students

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tokyo University · Academic / Other
• Sex: All
• Age: 10 Years – 11 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Mental Health Literacy
• Stigma (Social Distance)
• Help-seeking Intention

Interventions

Type	Name	Description
BEHAVIORAL	Indirect Contact	A 45-minute school-based mental health literacy lesson including an animated video, educational slides, and an additional indirect contact component in the form of a teacher-delivered story about a well-known soccer player who experienced and recovered from a mental health condition.
BEHAVIORAL	Standard MHL Lesson Only	A 45-minute standard mental health literacy lesson including an animated educational video and slides, without the indirect contact story component.

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-03-30
• Completion: 2026-08-30
• First posted: 2026-01-07
• Last updated: 2026-01-07