Skip to main content
OpenTrials
Completed

NCT Number: NCT07305064

A Virtual Peer Agent for Counseling Adolescents With Stressful Life Events

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent - Emotional Problem Agent Behavior Behavioral Symptoms Conversational Depression Personal Satisfaction Psychological Psychological Well-Being

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Peer Agent Counseling

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Social Support

    Time frame: Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention

    • 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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

  8. 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).

  9. 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.

  10. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Development and Evaluation of a Virtual Peer Agent for Psychological Counseling of Adolescents With Stressful Life Events : A Feasibility Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.