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

NCT ID: NCT07238842

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2026-02-28

Brief Summary

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

Conditions

Mental Health Literacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Teacher-Led Psychological Literacy Instruction

Intervention Type: BEHAVIORAL

This 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 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.

Group Type: EXPERIMENTAL

Virtual Agent-Delivered Psychological Literacy Training

Intervention Type: BEHAVIORAL

This 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.

Interventions

Teacher-Led Psychological Literacy Instruction

This 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.

Intervention Type: BEHAVIORAL

Virtual Agent-Delivered Psychological Literacy Training

This 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Nanhui No.2 Middle School

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Director of Shanghai Mental Health Center

Role: CONTACT

drminzhao@smhc.org.cn

(86)18017311005

Facility Contacts

Yijie Song

Role: primary

mae-0246@sjtu.edu.cn

(86)17584520246

Other Identifiers

MZhao-024

Identifier Type: -

Identifier Source: org_study_id