A Cluster-Randomized Pilot Trial of a School-Based Mental Health Literacy Program With and Without an Indirect Contact Component for 5th-Grade Students
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Tokyo University
- 入组人数
- 150
- 主要终点
- Social Distance Scale Score (Stigma)
概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Students were not informed whether they were in the intervention or control class. Classroom teachers delivering the lesson were aware of group assignment.
入排标准
- 年龄范围
- 10 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students enrolled in 5th grade at one of the eight participating public elementary schools in Kanazawa, Japan.
- •Aged 10-11 years old.
- •Passive consent obtained from guardians; verbal assent obtained from children.
- •Able to complete self-report questionnaires.
排除标准
- •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.
结局指标
主要结局
Social Distance Scale Score (Stigma)
时间窗: Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3)
A 5-item scale adapted from the Social Distance Scale using a vignette format. Each item rated on a 4-point scale (1=definitely willing to 4=definitely unwilling), total score range 4-20. Higher scores indicate greater stigma. Cronbach's alpha was 0.88.
次要结局
- Mental Health Knowledge Score(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Help-Seeking Intention(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Recognition of the necessity to seek help(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
- Intention to Help Peers(Baseline (T1), immediately post-intervention (T2), and 3-month follow-up (T3))
研究者
Nobuko Demura
PhD Student, Graduate School of Education
Tokyo University