VIPeerAgent for Adolescent Mental Health: A Three-Arm Parallel Randomized Controlled Trial | NCT07778758 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 21, 2026

VIPeerAgent for Adolescent Mental Health: A Three-Arm Parallel Randomized Controlled Trial

Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07778758
Lead Sponsor: Sun Yat-sen UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 234Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Aug 20, 2026Estimated
Primary Completion Date: Nov 30, 2026Estimated
Completion Date: Dec 10, 2026Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing
Brief Summary: 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.

Conditions

The medical conditions and diseases this study investigates.

Youth Mental Health
Psychological Distress in Adolescents and Young Adults
Early Intervention

Interventions

The treatments and procedures being evaluated in this study.

Virtual Peer Agent Intervention
Human peer mentor

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Adolescents and young adults aged 14-25 years. Experienced at least one moderate stressful life event within the past 6 months, with a score of moderate level or above on one or more items of the Stressful Life Events Scale.

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:

A history of clinically diagnosed severe mental or psychiatric disorders, such as major depressive disorder or schizophrenia.

Presence of suicidal ideation within the past 6 months or current suicidal ideation.

Receipt of professional psychological treatment within the past 12 months.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

Wei XiaContact

xiaw23@mail.sysu.edu.cn+8618823359471

Locations

Where the study is run and whether each site is currently recruiting.

School of Nursing, Sun Yat-Sen University

Guangzhou, Guangdong 510080, China

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Sun Yat-sen UniversityOTHER

Similar Studies

Other registered studies that closely resemble this one.

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.