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

NCT07238842 | Recruiting

• 1 other identifier: MZhao-024
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

Secondary Outcomes (7)

• Change in Depressive Symptom Severity

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

• Change in Anxiety Symptom Severity

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

• Change in Psychological Resilience

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

• Change in Behavioral and Emotional Difficulties

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

• Change in Sleep Quality

  From baseline to the end of the 6-week intervention period, and at 3-month follow-up

Study Arms (2)

Teacher-Led Psychological Literacy Instruction

ACTIVE COMPARATOR

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.

Behavioral: Teacher-Led Psychological Literacy Instruction

Virtual Agent-Delivered Psychological Literacy Program

EXPERIMENTAL

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.

Behavioral: Virtual Agent-Delivered Psychological Literacy Training

Interventions

Teacher-Led Psychological Literacy Instruction 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.

Teacher-Led Psychological Literacy Instruction

Virtual Agent-Delivered Psychological Literacy Training 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.

Virtual Agent-Delivered Psychological Literacy Program

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Nanhui No.2 Middle School

Shanghai, 201300, China

RECRUITING

Central Study Contacts

Director of Shanghai Mental Health Center

CONTACT

(86)18017311005; drminzhao@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: May 16, 2025
• Primary Completion: November 29, 2025
• Study Completion: February 28, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-05

Locations

CN (1)