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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07324265
Acronym
SMHLP-IC
Enrollment
128
Registered
2026-01-07
Start date
2025-12-15
Completion date
2026-03-30
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

BEHAVIORALIndirect 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.

BEHAVIORALStandard MHL Lesson Only

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

Sponsors

Tokyo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Students were not informed whether they were in the intervention or control class. Classroom teachers delivering the lesson were aware of group assignment.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

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.

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.

Design outcomes

Primary

MeasureTime frameDescription
Social Distance Scale Score (Stigma)Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)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.

Secondary

MeasureTime frameDescription
Mental Health Knowledge ScoreBaseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)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 at trial registration (based on preliminary/reference data); in the final analytic sample (n = 105, baseline), Cronbach's alpha was 0.69 (McDonald's omega = 0.70).
Help-Seeking IntentionBaseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)A vignette-based item asking whether students themselves would seek help if they were experiencing similar mental health difficulties. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to have the intention to seek help if they responded "Definitely yes".
Recognition of the necessity to seek helpBaseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)A single vignette-based item asking whether students thought the character in the scenario should seek help from others. Responses were on a 4-point scale: "Definitely yes", "Probably yes", "Probably not", and "Definitely not". Students were considered to recognize the necessity to seek help when they responded "Definitely yes".
Intention to Help PeersBaseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)Students were asked to rate their likelihood of performing various desirable supportive behaviors for a peer in distress. Each item was rated on a 4-point scale. Students were considered to have the intention to help if they selected "Definitely yes" for at least one of the behaviors. An example of a behavior is: "I would ask about or listen to their story to understand their situation in detail."

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026