Adolescent - Emotional ProblemNCT07305064
A Virtual Peer Agent for Counseling Adolescents With Stressful Life Events
A study testing Virtual Peer Agent Counseling in people with Adolescent - Emotional Problem and Agent, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to develop and evaluate a virtual companion agent for providing psychological support to adolescents who have recently experienced stressful life events. This is a single-arm, pre-post pilot trial. We plan to recruit 55 adolescents aged 14-25 to receive a 4-week intervention via the virtual agent. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Adolescent - Emotional Problem, Agent, Psychological
- What is being tested?
- Virtual Peer Agent Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged between 14 and 25 years. Self-report of experiencing a stressful life event of moderate or greater severity within the past 6 months.
- Total score on the relevant stress subscale of the Brief Symptom Inventory-53 (BSI-53) used for screening is < 63.
- Able to understand and provide informed consent (for minor participants, informed assent from the participant and informed consent from a parent or guardian are required).
Who cannot join
- Current or previous diagnosis of a severe mental disorder (e.g., major depressive disorder, schizophrenia, bipolar disorder).
- Having received more than 4 sessions of continuous professional psychotherapy or psychotropic medication treatment within the past 12 months.
- Presence of severe suicidal or self-injurious behavior that is not effectively controlled and requires immediate clinical intervention.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Nursing, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Development and Evaluation of a Virtual Peer Agent for Psychological Counseling of Adolescents With Stressful Life Events : A Feasibility Study
This study aims to develop and evaluate a virtual companion agent for providing psychological support to adolescents who have recently experienced stressful life events. This is a single-arm, pre-post pilot trial. We plan to recruit 55 adolescents aged 14-25 to receive a 4-week intervention via the virtual agent. The intervention primarily consists of multi-turn conversations focused on helping adolescents cope with stressful events, identify emotions, enhance social support, and adopt positive coping strategies. The primary objectives are to evaluate the effectiveness of the virtual agent in improving psychological symptoms, resilience, emotional intelligence, and perceived stress, and to comprehensively assess its feasibility, acceptability, and safety.
Read the detailed description
Over the past decade, mental health issues among adolescents have become increasingly prevalent. Approximately 14% of adolescents globally suffer from conditions like depression and anxiety. Adolescence is a critical developmental period, and mental health problems during this stage can have long-term negative impacts on relationships, academic performance, and future careers. However, due to factors such as cost, accessibility, and social stigma, many adolescents struggle to access timely and effective professional psychological services. In recent years, AI-based conversational agents have emerged as a potential solution. For some sensitive adolescents who are reluctant to confide in others or resistant to professional counseling, an anonymous, non-judgmental virtual conversational partner may serve as a lower-threshold avenue for them to open up and seek emotional support. Against this backdrop, this study aims to develop and evaluate a virtual companion agent specifically designed for adolescents. A total of 55 eligible adolescent participants will be enrolled. Participants will engage in a series of structured conversational interactions with the agent over 4 weeks and undergo multiple psychological assessments before, during, and after the intervention.
- Conditions
- Adolescent - Emotional Problem, Agent, Psychological, Conversational
- Being tested
- Virtual Peer Agent Counseling
- Keywords
- adolescent, Stressful Life Events, Conversational agent, psychological, peer, mental health, depression
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Peer Agent CounselingBehavioural
Also called Conversational agent
A conversational virtual agent designed to provide psychological support to adolescents through multi-turn dialogues. Intervention components include: psychoeducation, emotion recognition training, coping strategy development, social support exploration, and personalized behavioral task ("to-do list") setting. The intervention lasts for 4 weeks, involving multiple structured session nodes and follow-up reminders during inter-session intervals.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Peer Agent Counseling | Experimental | This is the single, experimental arm of the study. All enrolled participants receive the experimental intervention, which is the virtual peer agent counseling program. This group is designed to evaluate the feasibility and preliminary efficacy of the agent-delivered support system in a real-world context, with participants completing all outcome assessments pre- and post-intervention for within-subject comparison. Receives: Behavioral: Virtual Peer Agent Counseling |
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 [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Secondary outcomes (10)
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 [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
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 [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Emotional Intelligence
Description: 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. 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 [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
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 [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Participant Satisfaction
Acceptability of the virtual peer agent will be assessed using a Client Satisfaction Questionnaire (CSQ).
Measured: Within 1 week after intervention completion
Session Completion Rate
The duration of each participant's conversation per session, the total weekly interaction time, and the overall interaction time throughout the intervention period will be recorded.
Measured: Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Dropout Rate
Feasibility will be assessed by the study dropout rate, calculated as the percentage of participants who discontinue the study before the post-intervention assessment
Measured: From enrollment through the post-intervention assessment (at Week 4)
User Experience
The overall user experience during interaction with the virtual agent will be assessed using the User Experience Questionnaire (UEQ).
Measured: Within 1 week after intervention completion
Working Alliance
The quality of the therapeutic relationship between the participant and the virtual agent will be assessed using the Working Alliance Questionnaire(WAQ).The instrument consists of 12 items comprising three subscales: Task Goal, Emotional Bond, and Engagement. Each subscale contains 4 items and is rated on a 5-point scale.
Measured: Within 1 week after intervention completion
Perceived Warmth and Professionalism
Participant perceptions of the virtual agent's interpersonal qualities will be assessed using scales measuring Perceived Warmth and Professionalism.
Measured: Within 1 week after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start26 Dec 2025
- Primary completion1 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent - Emotional ProblemStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
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
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305064
- Sponsor's protocol ID
- VIPeer Agent
- Status last verified
- May 2026
- First submitted
- 29 Nov 2025
- Last updated
- 2 Jun 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Virtual Peer Agent for Psychological Counseling of Adolescents With Stressful Life Events : A Feasibility Study
- ClinicalTrials.gov ID
- NCT07305064
- Acronym / sponsor ID
- VIPeer Agent
- Conditions
- Adolescent - Emotional Problem, Agent, Psychological, Conversational
- Keywords
- adolescent, Stressful Life Events, Conversational agent, psychological, peer, mental health, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 26 Dec 2025 (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 study aims to develop and evaluate a virtual companion agent for providing psychological support to adolescents who have recently experienced stressful life events. This is a single-arm, pre-post pilot trial. We plan to recruit 55 adolescents aged 14-25 to receive a 4-week intervention via the virtual agent. The intervention primarily consists of multi-turn conversations focused on helping adolescents cope with stressful events, identify emotions, enhance social support, and adopt positive coping strategies. The primary objectives are to evaluate the effectiveness of the virtual agent in improving psychological symptoms, resilience, emotional intelligence, and perceived stress, and to comprehensively assess its feasibility, acceptability, and safety.
Detailed description
Over the past decade, mental health issues among adolescents have become increasingly prevalent. Approximately 14% of adolescents globally suffer from conditions like depression and anxiety. Adolescence is a critical developmental period, and mental health problems during this stage can have long-term negative impacts on relationships, academic performance, and future careers. However, due to factors such as cost, accessibility, and social stigma, many adolescents struggle to access timely and effective professional psychological services. In recent years, AI-based conversational agents have emerged as a potential solution. For some sensitive adolescents who are reluctant to confide in others or resistant to professional counseling, an anonymous, non-judgmental virtual conversational partner may serve as a lower-threshold avenue for them to open up and seek emotional support. Against this backdrop, this study aims to develop and evaluate a virtual companion agent specifically designed for adolescents. A total of 55 eligible adolescent participants will be enrolled. Participants will engage in a series of structured conversational interactions with the agent over 4 weeks and undergo multiple psychological assessments before, during, and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Peer Agent Counseling | Experimental | Behavioral: Virtual Peer Agent CounselingThis is the single, experimental arm of the study. All enrolled participants receive the experimental intervention, which is the virtual peer agent counseling program. This group is designed to evaluate the feasibility and preliminary efficacy of the agent-delivered support system in a real-world context, with participants completing all outcome assessments pre- and post-intervention for within-subject comparison. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged between 14 and 25 years. Self-report of experiencing a stressful life event of moderate or greater severity within the past 6 months.
- Total score on the relevant stress subscale of the Brief Symptom Inventory-53 (BSI-53) used for screening is < 63.
- Able to understand and provide informed consent (for minor participants, informed assent from the participant and informed consent from a parent or guardian are required).
Key exclusion criteria (3 listed)
- Current or previous diagnosis of a severe mental disorder (e.g., major depressive disorder, schizophrenia, bipolar disorder).
- Having received more than 4 sessions of continuous professional psychotherapy or psychotropic medication treatment within the past 12 months.
- Presence of severe suicidal or self-injurious behavior that is not effectively controlled and requires immediate clinical intervention.
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 CounselingAlso: Conversational agentA conversational virtual agent designed to provide psychological support to adolescents through multi-turn dialogues. Intervention components include: psychoeducation, emotion recognition training, coping strategy development, social support exploration, and personalized behavioral task ("to-do list") setting. The intervention lasts for 4 weeks, involving multiple structured session nodes and follow-up reminders during inter-session intervals. | Behavioural | Virtual Peer Agent Counseling |
Primary outcome
Level of Psychological Symptoms
Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
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.
10 secondary outcomes
Psychological Resilience
Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Social Support
Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Emotional Intelligence
Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Coping Strategies
Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Participant Satisfaction
Time frame: Within 1 week after intervention completion
Session Completion Rate
Time frame: Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
Dropout Rate
Time frame: From enrollment through the post-intervention assessment (at Week 4)
User Experience
Time frame: Within 1 week after intervention completion
Working Alliance
Time frame: Within 1 week after intervention completion
Perceived Warmth and Professionalism
Time frame: Within 1 week after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 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.
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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. This study is not recruiting at the moment.
Wei Xia, PhD principal investigator
Sun Yat-sen University
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 Counseling in people with Adolescent - Emotional Problem and Agent, 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 3 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: finished, as of the sponsor's last update on 2 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Psychological Symptoms (time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention). 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 2 Jun 2026.