A Virtual Peer Agent for Counseling Adolescents With Stressful Life Events

December 11, 2025 updated by: Wei XIA, PhD, Sun Yat-sen University

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 35 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.

Study Overview

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 minimum of 35 participants are required to complete all study procedures. Accounting for an estimated attrition rate of 20%, a total of 50 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 Type

Interventional

Enrollment (Estimated)

50

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 Contact Backup

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:

  • 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).

Exclusion Criteria:

  • 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.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Peer Agent Counseling
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.
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.
Other Names:
  • Conversational agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Resilience
Time Frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention
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 [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
1. 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 [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
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.
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
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 [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
Acceptability of the virtual peer agent will be assessed using a Client Satisfaction Questionnaire (CSQ).
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
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.
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)
Feasibility will be assessed by the study dropout rate, calculated as the percentage of participants who discontinue the study before the post-intervention assessment
From enrollment through the post-intervention assessment (at Week 4)
User Experience
Time Frame: Within 1 week after intervention completion
The overall user experience during interaction with the virtual agent will be assessed using the User Experience Questionnaire (UEQ).
Within 1 week after intervention completion
Working Alliance
Time Frame: Within 1 week after intervention completion
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.
Within 1 week after intervention completion
Perceived Warmth and Professionalism
Time Frame: Within 1 week after intervention completion
Participant perceptions of the virtual agent's interpersonal qualities will be assessed using scales measuring Perceived Warmth and Professionalism.
Within 1 week after intervention completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expert Evaluation Questionnaire
Time Frame: Within 1 week after intervention completion
Safety will be assessed by an Expert Evaluation Questionnaire, where psychology experts rate the system's logic and the quality of its responses to ensure they are safe and appropriate.
Within 1 week after intervention completion
High-risk Identification Match Rate
Time Frame: Within 1 week after intervention completion
Safety will be assessed by the high-risk identification match rate, which measures the consistency between the virtual agent and human experts in flagging high-risk dialogue content.
Within 1 week after intervention completion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Wei Xia, 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)

December 5, 2025

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

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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