Virtual agent versus teacher-led mental health literacy for adolescents
A Non-inferiority Study of the Virtual Agent-based Versus Teacher-led Psychological Literacy Enhancement Method in Improving Adolescents' Mental Health Literacy
NA · Shanghai Mental Health Center · NCT07238842
This project tests whether a digital mental health literacy program led by an AI virtual agent can help students aged 11–18 as much as traditional teacher-led lessons.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07238842 on ClinicalTrials.gov |
What this trial studies
The trial compares two 6-week programs delivered at a Shanghai middle/high school: one run by an AI-powered virtual agent and the other taught by a teacher, with students receiving weekly sessions. Participants complete baseline and post-intervention measures of mental health literacy and secondary outcomes such as depression, anxiety, psychological resilience, sleep quality, and digital well-being. Eligible participants are students aged 11–18 who can use a smartphone or computer and do not have diagnosed psychiatric disorders or severe physical illness. The design tests non-inferiority of the virtual agent delivery to determine whether digital delivery achieves comparable outcomes to teacher-led instruction.
Who should consider this trial
Good fit: Ideal candidates are students aged 11–18 at the participating Shanghai school who can operate a smartphone or computer, have normal reading and language abilities, and provide informed (and parental where required) consent.
Not a fit: Students with diagnosed psychiatric disorders, severe physical illnesses, central nervous system disease, substance use disorders, or those unable to use digital devices are unlikely to benefit from this specific program.
Why it matters
Potential benefit: If successful, the virtual agent approach could expand access to consistent, scalable mental health education for adolescents while reducing reliance on teacher time.
How similar studies have performed: Previous digital mental health literacy and e-learning programs have shown mixed but generally promising results, while AI virtual-agent delivery is relatively new and less extensively validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Shanghai Nanhui No.2 Middle School — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Director of Shanghai Mental Health Center
- Email: drminzhao@smhc.org.cn
- Phone: (86)18017311005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mental Health Literacy