VIPeerAgent for Adolescent Mental Health

August 22, 2026 updated by: Wei XIA, PhD, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • School of Nursing, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adolescents and young adults aged 14-25 years.
  • Experienced at least one moderate or more severe stressful life event within the past 6 months.
  • Able to read and communicate in Chinese.
  • Willing to participate in the study and provide informed consent.
  • Have a BSI-53 score <63.

Exclusion Criteria:

  • A history of clinically diagnosed severe mental or psychiatric disorders, such as major depressive disorder or schizophrenia.
  • Current suicidal ideation or suicidal ideation within the past 6 months.
  • Receipt of professional psychological or psychiatric treatment within the past 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIPeer Agent Intervention Group
Other: Virtual Peer Agent Intervention
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.
Active Comparator: Human peer mentor
Other: Human peer mentor
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.
No Intervention: Usual Care control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Psychological Symptoms
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.
Level of Psychological Symptoms: Assessed by change in scores on the Brief Symptom Inventory-53 (BSI-53). This 53-item instrument, which encompasses 9 dimensions, is rated on a 5-point Likert scale. A cut-off point of 63 or higher is used to define a positive case.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Support
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.
Social Support: Assessed by scores on the Perceived Social Support Scale (PSSS). The Perceived Social Support Scale (PSSS) consists of 12 items, which are divided into three dimensions: family, friend, and other support. Using a 7-point Likert scale, the total score (range: 12-84) is calculated, with a higher score reflecting a higher level of perceived social support.
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.
Stressful life events
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.
The Adolescent Self-Rating Life Events Checklist (ASLEC) assesses the frequency and impact of stressful life events in adolescents. It comprises 27 items covering five domains: punishment, loss, interpersonal stress, academic stress, and adaptation problems. Each item is rated on a 6-point scale from 0 (never occurred) to 5 (extremely severe). Scale range: 0 to 135 Higher scores indicate a worse outcome (greater negative impact of stressful life events).
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.
Coping Strategies
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.
Coping Strategies: Assessed by scores on the Coping Strategy Indicator - Short Form in Chinese (CSIS-SFC). The scale is composed of 21 items divided into four subscales: Task-Oriented Coping, Emotion-Oriented Coping, Distraction Coping, and Social Diversion Coping. It is a 5-point Likert scale.
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.
Psychological Resilience
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.
Psychological Resilience: Assessed by change in scores on the Connor-Davidson Resilience Scale (CD-RISC). The instrument consists of 25 items distributed among three dimensions: hardiness (13 items), strength (8 items), and optimism (4 items). Responses are recorded on a 5-point Likert scale, yielding a total score between 0 and 100, where a higher score denotes a higher level of psychological resilience.
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.
Emotional Intelligence
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.
Emotional Intelligence: Assessed by change in scores on the Wong and Law Emotional Intelligence Scale (WLEIS). The Emotional Intelligence Scale contains 16 items across four subscales: Self-Emotion Appraisal and Expression, Others' Emotion Appraisal, Regulation of Self-Emotion, and Use of Emotion. A 7-point scoring system is used, and the total score for each subscale is used to determine the competency level in that specific dimension.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

August 18, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIPA-RCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon reasonable request and after approval of a research proposal, de-identified individual participant data that underlie the results of this study (specifically, the pre- and post-intervention scale scores) will be made available. This does not include any raw transcript data from conversations with the virtual agent, to protect participant privacy.

IPD Sharing Time Frame

After the publication of the study

IPD Sharing Access Criteria

The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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