A Non-inferiority Study of the Virtual Agent-based Versus Teacher-led Psychological Literacy Enhancement Method in Improving Adolescents' Mental Health Literacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Change in Adolescent Mental Health Literacy
研究概览
简要总结
The goal of this clinical trial is to determine whether a digital psychological literacy program delivered by an AI-powered virtual agent is non-inferior to traditional teacher-led instruction in improving mental health literacy among adolescents. The study focuses on middle and high school students aged 11 to 18 years attending a school in Shanghai, China, including those with varying levels of emotional well-being but excluding those with diagnosed psychiatric disorders or severe physical illness.
The main questions it aims to answer are:
Is the virtual agent-delivered psychological literacy program as effective as teacher-led instruction in improving adolescents' mental health literacy? Does the virtual agent intervention lead to comparable or better outcomes in secondary measures such as depression, anxiety, psychological resilience, sleep quality, and digital well-being?
Researchers will compare students receiving 6 weekly sessions from a virtual digital agent to students receiving the same curriculum delivered by trained psychology teachers to see if the AI-based approach achieves similar improvements in mental health knowledge, attitudes, and help-seeking behaviors.
Participants will:
Complete online assessments at baseline, week 3, week 6 and week 18 covering mental health literacy (UMHL-A), depression (PHQ-9), anxiety (GAD-7), psychological resilience (RSCA), and other well-being indicators Attend one 45-60 minute session per week for 6 weeks, either interacting with the virtual agent or participating in a teacher-led class Optionally take part in a brief satisfaction survey and/or a focus group interview after the intervention to share their experiences
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 11 and 18 years inclusive.
- •Able to fluently operate a computer or smartphone.
- •Possess normal language expression and reading comprehension abilities.
- •Voluntarily agree to participate in the study and provide signed informed consent (and parental consent where required by local regulations).
排除标准
- •Diagnosed with a psychiatric disorder that impairs the ability to complete assessments or participate in the intervention.
- •Suffering from a severe physical illness, central nervous system disease, or substance use disorder that could interfere with study participation or outcomes.
研究组 & 干预措施
Teacher-Led Psychological Literacy Instruction
Participants in this arm receive the identical 6-week psychological literacy curriculum, but delivered by trained school psychology teachers through traditional face-to-face classroom instruction. Each weekly session lasts 45-60 minutes and follows the same structure and content as the virtual agent arm, including the same four thematic modules. Teachers use standard pedagogical methods such as lectures, group discussions, role-playing, and worksheet activities. This arm serves as the active control condition, representing the current standard of school-based mental health education in China.
干预措施: Teacher-Led Psychological Literacy Instruction (Behavioral)
Virtual Agent-Delivered Psychological Literacy Program
Participants in this arm receive a 6-week psychological literacy curriculum delivered entirely by an AI-powered virtual digital agent. The program consists of weekly 45-60 minute interactive sessions aligned with China's national guidelines for mental health education (e.g., Guidelines for Mental Health Education in Primary and Secondary Schools, 2012). The content covers four core modules: (1) psychological foundations and self-awareness, (2) stress and challenge coping skills, (3) interpersonal and communication skills, and (4) healthy lifestyle and future planning. The virtual agent uses scripted but adaptive dialogue, emotion-aware responses, and multimedia engagement to deliver the same evidence-based curriculum used in the control arm. Sessions are conducted in a classroom setting using school-provided computers.
干预措施: Virtual Agent-Delivered Psychological Literacy Training (Behavioral)
结局指标
主要结局
Change in Adolescent Mental Health Literacy
时间窗: Baseline, week 3, week 6, week 18
Mental health literacy is assessed using the Universal Mental Health Literacy Scale for Adolescents (UMHL-A), a validated 17-item Chinese-language instrument. Part A contains eight items assessing attitudes toward help-seeking and mental health-related stigma, scored on a 5-point Likert scale (range: 8-40). Part B contains nine items assessing general mental health knowledge and knowledge of specific mental illnesses, with each item scored 0 or 1 (range: 0-9). The total score ranges from 8 to 49. Higher scores indicate greater mental health literacy, including more positive attitudes and better knowledge, whereas lower scores indicate poorer mental health literacy. The Chinese version has demonstrated good reliability and validity among adolescents.
次要结局
- Change in Depressive Symptom Severity(baseline, week 3, week 6, week 18)
- Change in Anxiety Symptom Severity(Baseline, week 3, week 6, week 18)
- Change in Sleep Quality(Baseline， week 3， week 6， week 18)
- Change in Risk of Gaming Disorder(Baseline, week 3, week 6, week18)
- Change in Self-esteem(Baseline，week 3， week 6 ，week 18)
- Change in Perceived social support(Baseline, week 3, week 6, week18)
- Change in Psychological Resilience(Baseline, week 3, week 6, week 18)