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

NCT07324265 | Completed

• 1 other identifier: SMHLP-IC-2025
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Mental health literacy; Stigma reduction; Indirect contact; Social distance; Help-seeking intentions; School-based intervention; Elementary school students

Outcome Measures

Primary Outcomes (1)

• Social Distance Scale Score (Stigma)

  A 4-item scale adapted from the Social Distance Scale using a vignette format. (Note: The scale was originally administered with 5 items; however, Items 4 and 5 were found to be duplicates during data checking, and Item 5 was excluded from the primary outcome score. The 4-item version was used for the primary analysis.) Each item rated on a 4-point scale (1=definitely willing to 4=definitely unwilling), total score range 4-16. Higher scores indicate greater stigma. Cronbach's alpha was 0.82.

  Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)

Secondary Outcomes (4)

• Mental Health Knowledge Score

  Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)

• Help-Seeking Intention

  Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)

• Recognition of the necessity to seek help

  Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)

• Intention to Help Peers

  Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)

Study Arms (2)

Indirect Contact

EXPERIMENTAL

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.

Behavioral: Indirect Contact

Standard MHL Lesson Only

ACTIVE COMPARATOR

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.

Behavioral: Standard MHL Lesson Only

Interventions

Indirect Contact BEHAVIORAL

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.

Indirect Contact

Standard MHL Lesson Only BEHAVIORAL

A 45-minute standard mental health literacy lesson including an animated educational video and slides, without the indirect contact story component.

Standard MHL Lesson Only

Eligibility Criteria

• Age: 10 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students enrolled in one of the four participating 5th-grade classes at a public elementary school in Tokyo, Japan.
• Aged 10-11 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)

University of Tokyo

Bunkyō-Ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Students were not informed whether they were in the intervention or control class. Classroom teachers delivering the lesson were aware of group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student, Graduate School of Education

Model Details: Cluster-randomized parallel-group design with four 5th-grade classes assigned (2:2) to intervention or control conditions. Randomization occurs at the class level within the same school.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: December 15, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)