NCT07305064

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 26, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

November 29, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

adolescentStressful Life EventsConversational agentpsychologicalpeermental healthdepression

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Other Outcomes (2)

  • Expert Evaluation Questionnaire

    Within 1 week after intervention completion

  • High-risk Identification Match Rate

    Within 1 week after intervention completion

Study Arms (1)

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.

Behavioral: Virtual Peer Agent Counseling

Interventions

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.

Also known as: Conversational agent
Virtual Peer Agent Counseling

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Study Officials

  • Wei Xia

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 26, 2025

Study Start

December 5, 2025

Primary Completion

January 10, 2026

Study Completion

January 30, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After the publication of the study
Access Criteria
The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.