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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Mental Health Literacy

Treatments: Behavioral: Teacher-Led Psychological Literacy Instruction; Behavioral: Virtual Agent-Delivered Psychological Literacy Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07238842

MZhao-024

Details and patient eligibility

About

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

Enrollment: 360 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

360 participants in 2 patient groups

Teacher-Led Psychological Literacy Instruction

Active Comparator group

Description:

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.

Treatment:

Behavioral: Teacher-Led Psychological Literacy Instruction

Virtual Agent-Delivered Psychological Literacy Program

Experimental group

Description:

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.

Treatment:

Behavioral: Virtual Agent-Delivered Psychological Literacy Training