Youth Mental HealthNCT07778758
VIPeerAgent for Adolescent Mental Health
A study testing Virtual Peer Agent Intervention and Human peer mentor in people with Youth Mental Health and Psychological Distress in Adolescents and Young Adults, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Youth Mental Health, Psychological Distress in Adolescents and Young Adults, Early Intervention
- What is being tested?
- Virtual Peer Agent Intervention and Human peer mentor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2026to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
School of Nursing, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Wei Xia, +8618823359471, xiaw23@mail.sysu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Youth Mental Health, Psychological Distress in Adolescents and Young Adults, Early Intervention
- Being tested
- Virtual Peer Agent Intervention, Human peer mentor
- Keywords
- mental health, Agent, Randomized Controlled Trial, youth, adolescent
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Peer Agent InterventionOther
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.
Human peer mentorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VIPeer Agent Intervention Group | Experimental | Not described Receives: Other: Virtual Peer Agent Intervention |
| Human peer mentor | Active comparator | Not described Receives: Other: Human peer mentor |
| Usual Care control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Psychological Symptoms
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.
Measured: 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 outcomes (5)
Social Support
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Youth Mental HealthStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778758
- Sponsor's protocol ID
- VIPA-RCT-2026
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing
- ClinicalTrials.gov ID
- NCT07778758
- Acronym / sponsor ID
- VIPA-RCT-2026
- Conditions
- Youth Mental Health, Psychological Distress in Adolescents and Young Adults, Early Intervention
- Keywords
- mental health, Agent, Randomized Controlled Trial, youth, adolescent
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VIPeer Agent Intervention Group | Experimental | Other: Virtual Peer Agent Intervention |
| Human peer mentor | Active comparator | Other: Human peer mentor |
| Usual Care control | No intervention | – |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Peer Agent InterventionParticipants 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. | Other | VIPeer Agent Intervention Group |
| Human peer mentorParticipants 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. | Other | Human peer mentor |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Youth Mental Health
Not yet recruiting
Enlace Familiar: Supporting the Mental Health of Latino Adolescents
Mental Health
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruitingObservational study
Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis
Atopic Dermatitis, Eczema
Recruiting
The Mindful Smartphone Use Study
Depression and/or Anxiety Symptoms, Problematic Phone Use Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Peer Agent Intervention and Human peer mentor in people with Youth Mental Health and Psychological Distress in Adolescents and Young Adults, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Xia (+8618823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.