VIPeerAgent for Adolescent Mental Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-25
SponsorSun Yat-sen University

About this trial

This three-arm parallel randomized controlled trial aims to evaluate the effectiveness of VIPeerAgent, a virtual peer support agent, in improving mental health outcomes among adolescents and young adults aged 14-25 years experiencing psychological distress without a diagnosed mental disorder. Participants will be randomized to receive support from VIPeerAgent, a human peer mentor, or usual care. The study will assess whether VIPeerAgent is non-inferior to human peer support and superior to usual care in promoting mental health. Outcomes include mental health status, psychological resilience, coping strategies, perceived social support, and emotional intelligence. The findings will provide evidence for the effectiveness and scalability of AI-assisted peer support as an early intervention approach for youth mental health.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescents and young adults aged 14-25 years.

Experienced at least one moderate or more severe stressful life event within the past 6 months.

Able to read and communicate in Chinese.

Willing to participate in the study and provide informed consent.

Disqualifiers

A history of clinically diagnosed severe mental or psychiatric disorders, such as major depressive disorder or schizophrenia.

Current suicidal ideation or suicidal ideation within the past 6 months.

Receipt of professional psychological or psychiatric treatment within the past 12 months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Peer Agent Intervention

    Other intervention

    Participants in the VIPeerAgent group will engage in multi-turn conversations with the virtual peer agent. The intervention focuses on providing psychological support in three key areas: emotional awareness and regulation, social support enhancement, and coping strategy development. At the end of each interaction, VIPeerAgent will guide participants in developing an individualized and actionable to-do list based on their personal needs and goals.

  • Human peer mentor

    Other intervention

    Participants in the human peer mentor group will receive support from trained peer mentors. The intervention components are comparable to those delivered by VIPeerAgent and include peer support consultations, enhanced follow-up, individualized action planning through to-do lists, and personalized supportive messages.

Treatment groups

234 Participants
are divided into 3 treatment groups
Group A: VIPeer Agent Intervention GroupExperimental treatment 1 intervention
Group B: Human peer mentorActive comparator 1 intervention
Group C: Usual Care controlNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.

Secondary outcomes

1

Social Support

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.

Time frame
Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
2

Stressful life events

The Adolescent Self-Rating Life Events Checklist (ASLEC) assesses the frequency and impact of stressful life events in adolescents. It comprises 27 items covering five domains: punishment, loss, interpersonal stress, academic stress, and adaptation problems. Each item is rated on a 6-point scale from 0 (never occurred) to 5 (extremely severe). Scale range: 0 to 135 Higher scores indicate a worse outcome (greater negative impact of stressful life events).

Time frame
Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
3

Coping Strategies

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.

Time frame
Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.
4

Psychological Resilience

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.

Time frame
Baseline, weekly during the intervention period (Week 1, Week 2, Week 3, and Week 4), and follow-up assessments at 1 month and 3 months post-intervention completion.

Other outcomes

Sponsors and contacts

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