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
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).
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.
Parallel
Teacher-Led Psychological Literacy Instruction
BehavioralThis intervention delivers the identical 6-week psychological literacy curriculum as the virtual agent arm, but through standard face-to-face instruction by certified school psychology teachers. Teachers follow a detailed manualized lesson plan covering the same four thematic modules and learning objectives. Sessions include traditional pedagogical techniques such as didactic teaching, group discussion, role-playing exercises, reflective writing, and in-class activities. Each session lasts 45-60 minutes and occurs weekly in the regular classroom setting. Teachers are trained to adhere to the protocol to ensure content equivalence with the virtual agent condition, though minor natural variations in delivery style, pacing, or classroom interaction may occur. This intervention represents the current standard of practice for school-based mental health education in China and serves as the active control condition.
Virtual Agent-Delivered Psychological Literacy Training
BehavioralThis intervention consists of a 6-week, school-based psychological literacy program delivered by an AI-powered virtual digital agent. The agent uses real-time animation, speech synthesis, and scripted but context-sensitive dialogue to guide students through evidence-based mental health content aligned with China's national mental health education guidelines. The curriculum includes four modules: (1) psychological foundations and self-awareness, (2) stress and coping skills, (3) interpersonal and family communication, and (4) healthy digital habits, sleep, and future planning. Each weekly session (45-60 minutes) is fully digital, interactive, and delivered via classroom computers. The virtual agent maintains consistent content fidelity across all participants. This intervention leverages AI technologies-including natural language understanding and emotion-aware feedback-but does not provide clinical therapy or real-time personalized adaptation beyond pre-programmed branching logic.
Change in Adolescent Mental Health Literacy
Mental health literacy is assessed using the UMHL-A (Adolescent Mental Health Literacy Scale), a validated Chinese-language instrument that evaluates two key domains: Part A: Knowledge and understanding of mental health concepts, common psychological problems, risk/protective factors, and help-seeking resources. Part B: Attitudes toward mental health issues and behavioral intentions to seek help or support others. Higher total scores indicate greater mental health literacy. The scale has demonstrated strong reliability and validity in Chinese adolescent populations.
Change in Depressive Symptom Severity
Depressive symptoms are measured using the PHQ-9 (Patient Health Questionnaire-9), a widely used 9-item self-report scale that assesses the frequency of core depression symptoms (e.g., low mood, anhedonia, sleep disturbance) over the past two weeks. Each item is scored from 0 ("not at all") to 3 ("nearly every day"), yielding a total score from 0 to 27. Higher scores indicate more severe depressive symptoms. The Chinese version has established reliability and clinical utility.
Change in Anxiety Symptom Severity
Anxiety symptoms are assessed using the GAD-7 (Generalized Anxiety Disorder-7), a 7-item self-report questionnaire that measures the frequency of anxiety symptoms (e.g., excessive worry, restlessness, difficulty controlling worry) over the past two weeks. Scores range from 0 to 21, with higher scores indicating greater anxiety severity. The Chinese version is well-validated for use in adolescents.
Change in Psychological Resilience
Psychological resilience is evaluated using the RSCA (Resilience Scale for Chinese Adolescents), a culturally adapted scale that measures adolescents' capacity to adapt positively in the face of adversity. It assesses domains such as self-efficacy, emotional regulation, goal orientation, and perceived social support. Higher scores reflect greater resilience.
Change in Behavioral and Emotional Difficulties
Emotional and behavioral problems are screened using the SDQ (Strengths and Difficulties Questionnaire), specifically the subscales for emotional symptoms, conduct problems, hyperactivity, peer relationship issues, and prosocial behavior. The total difficulties score (range: 0-40) is used as a global indicator of psychosocial adjustment. The Chinese adolescent version is reliable and commonly used in school settings.
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