Status
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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
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.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 1 patient group
Loading...
Central trial contact
Shuliag Zhao, Master; Wei Xia, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal