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NOT YET RECRUITING
NCT07324265
NA

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

Sponsor: Tokyo University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

10 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-12-15

Completion Date

2026-08-30

Last Updated

2026-01-07

Healthy Volunteers

Yes

Interventions

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.