Mental Health LiteracySMHLP-ICNCT07324265
Pilot Cluster RCT of an Indirect Contact Mental Health Literacy Program for 5th-Grade Students
A study testing Indirect Contact and Standard MHL Lesson Only in people with Mental Health Literacy and Stigma (Social Distance), run by Tokyo University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Literacy, Stigma (Social Distance), Help-seeking Intention
- What is being tested?
- Indirect Contact and Standard MHL Lesson Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteJapan
- Study dates
- 15 Dec 2025to 30 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Indirect Contact, Standard MHL Lesson Only
- Keywords
- Mental health literacy, Stigma reduction, Indirect contact, Social distance, Help-seeking intentions, School-based intervention, Elementary school students
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect ContactBehavioural
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.
Standard MHL Lesson OnlyBehavioural
A 45-minute standard mental health literacy lesson including an animated educational video and slides, without the indirect contact story component.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard MHL Lesson Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)
Secondary outcomes (4)
Mental Health Knowledge Score
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).
Measured: Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)
Help-Seeking Intention
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".
Measured: Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)
Recognition of the necessity to seek help
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".
Measured: Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)
Intention to Help Peers
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."
Measured: Baseline (T1), immediately post-intervention (T2), and 2-3 month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Dec 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuko Demura, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324265
- Sponsor's protocol ID
- SMHLP-IC-2025
- Acronym
- SMHLP-IC
- Status last verified
- Jul 2026
- First submitted
- 22 Dec 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this study involves minors in a school-based setting and includes sensitive educational and mental health-related information, individual participant data cannot be shared. Disclosure of such data could risk re-identification even after de-identification procedures. In accordance with ethical guidelines and institutional policies, IPD will not be made available.