Actively Recruiting

Phase Not Applicable
Age: 11Years - 18Years
All Genders
Healthy Volunteers
NCT07238842

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

Led by Shanghai Mental Health Center · Updated on 2025-11-20

360

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 11Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 and provide signed informed consent (and parental consent if required)
Not Eligible

You will not qualify if you...

  • Diagnosed with a psychiatric disorder that impairs ability to complete assessments or participate
  • Suffering from severe physical illness, central nervous system disease, or substance use disorder interfering with participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Nanhui No.2 Middle School

Shanghai, China, 201300

Actively Recruiting

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Research Team

D

Director of Shanghai Mental Health Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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