School of Nursing, Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
NCT Number: NCT07778758
This three-arm parallel randomized controlled trial aims to evaluate the effectiveness of VIPeerAgent, a virtual peer support agent, in improving mental health outcomes among adolescents and young adults aged 14-25 years experiencing psychological distress without a diagnosed mental disorder. Participants will be randomized to receive support from VIPeerAgent, a human peer mentor, or usual care. The study will assess whether VIPeerAgent is non-inferior to human peer support and superior to usual care in promoting mental health. Outcomes include mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence. The findings will provide evidence for the effectiveness and scalability of AI-assisted peer support as an early intervention approach for youth mental health.
Trial opening soon.
Get Notified14 year–25 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510080, China
This study aims to evaluate the effectiveness of VIPeerAgent, an artificial intelligence-powered virtual peer support agent, in promoting mental health among adolescents and young adults aged 14-25 years who experience psychological distress but do not meet diagnostic criteria for a mental disorder. The study is designed to support the early identification, early intervention, and prevention of mental health problems in youth populations.
The study adopts a three-arm parallel randomized controlled trial with a non-inferiority and superiority testing framework. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the VIPeerAgent intervention group, (2) the human peer mentor support group, or (3) the usual-care control group.
Participants in the VIPeerAgent group will engage in multi-turn conversations with the virtual peer agent. The intervention focuses on providing psychological support in three key areas: emotional awareness and regulation, social support enhancement, and coping strategy development. At the end of each interaction, VIPeerAgent will guide participants in developing an individualized and actionable to-do list based on their personal needs and goals. Additional support will be provided through proactive follow-up and personalized content recommendations tailored to participants' psychological needs.
Participants in the human peer mentor group will receive support from trained peer mentors. The intervention components are comparable to those delivered by VIPeerAgent and include peer support consultations, enhanced follow-up, individualized action planning through to-do lists, and personalized supportive messages. Participants in the usual-care control group will receive routine mental health education through weekly mental health promotion materials. The intervention period will last four weeks.
The primary outcome is improvement in mental health status during the follow-up period, assessed using the Brief Symptom Inventory-53 (BSI-53). Secondary outcomes include psychological resilience, coping strategies, perceived social support, and emotional intelligence.
In addition to the randomized controlled trial, an explanatory qualitative study will be conducted following completion of the intervention. Using purposive sampling, participants with diverse experiences and intervention responses will be invited to participate in semi-structured interviews. The qualitative interviews will explore participants' perceptions of the intervention, user experiences, acceptability, engagement, and perceived impact. Findings from the qualitative analysis will be used to complement and help explain the quantitative trial results, providing a deeper understanding of the mechanisms, benefits, and implementation considerations of AI-assisted peer support for youth mental health.
This design will generate comprehensive evidence regarding both the effectiveness and user experience of VIPeerAgent and inform the future development, implementation, and scalability of AI-supported mental health interventions for adolescents and young adults.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Able to read and communicate in Chinese. Willing to actively participate in the study and provide written informed consent.
A Brief Symptom Inventory-53 (BSI-53) score < 63, indicating the absence of a clinically diagnosed psychological disorder.
Exclusion criteria
Presence of suicidal ideation within the past 6 months or current suicidal ideation.
Receipt of professional psychological treatment within the past 12 months.
Participants in the VIPeerAgent group will engage in multi-turn conversations with the virtual peer agent. The intervention focuses on providing psychological support in three key areas: emotional awareness and regulation, social support enhancement, and coping strategy development. At the end of each interaction, VIPeerAgent will guide participants in developing an individualized and actionable to-do list based on their personal needs and goals.
Participants in the human peer mentor group will receive support from trained peer mentors. The intervention components are comparable to those delivered by VIPeerAgent and include peer support consultations, enhanced follow-up, individualized action planning through to-do lists, and personalized supportive messages.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Time frame: Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
Contact information is provided by the study sponsor or research team.
Sun Yat-sen University
Other
Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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