- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07305064
A Virtual Peer Agent for Counseling Adolescents With Stressful Life Events
Development and Evaluation of a Virtual Peer Agent for Psychological Counseling of Adolescents With Stressful Life Events : A Feasibility Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wei Xia, Phd
- Phone Number: 8618823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Contact Backup
- Name: Shuliag Zhao, Master
- Phone Number: 8617863634052
- Email: zhaoshliang@mail2.sysu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Wei Xia, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIPeer Agent
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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