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临床试验/NCT07305064
NCT07305064已完成不适用

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

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年12月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
Level of Psychological Symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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 <
  • 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).

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Virtual Peer Agent Counseling (Behavioral)

结局指标

主要结局

Level of Psychological Symptoms

时间窗: 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.

次要结局

  • Psychological Resilience(Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention)
  • Social Support(Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention)
  • Emotional Intelligence(Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention)
  • Coping Strategies(Baseline [week 0], Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention)
  • Participant Satisfaction(Within 1 week after intervention completion)
  • Session Completion Rate(Week 1 of intervention, Week 2 of intervention, Week 3 of intervention, Week 4 of intervention)
  • Dropout Rate(From enrollment through the post-intervention assessment (at Week 4))
  • User Experience(Within 1 week after intervention completion)
  • Working Alliance(Within 1 week after intervention completion)
  • Perceived Warmth and Professionalism(Within 1 week after intervention completion)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei XIA, PhD

Associate professor

Sun Yat-sen University

研究点 (1)

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