Non-inferiority of Virtual vs. Traditional Methods in Adolescent Mental Health Literacy

A Non-inferiority Study of the Virtual Agent-based Versus Teacher-led Psychological Literacy Enhancement Method in Improving Adolescents' Mental Health Literacy

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

Inclusion Criteria:

1. Age between 11 and 18 years inclusive.
2. Able to fluently operate a computer or smartphone.
3. Possess normal language expression and reading comprehension abilities.
4. Voluntarily agree to participate in the study and provide signed informed consent (and parental consent where required by local regulations).

Exclusion Criteria:

1. Diagnosed with a psychiatric disorder that impairs the ability to complete assessments or participate in the intervention.
2. Suffering from a severe physical illness, central nervous system disease, or substance use disorder that could interfere with study participation or outcomes.