VIPeerAgent for Adolescent Mental Health
Efficacy of VIPeerAgent for Mental Health Intervention in Adolescents: A Three-Arm Parallel Randomized Controlled Trial With Non-Inferiority and Superiority Testing
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study aims to evaluate the effectiveness of VIPeerAgent, an artificial intelligence-powered virtual peer support agent, in promoting mental health among adolescents and young adults aged 14-25 years who experience psychological distress but do not meet diagnostic criteria for a mental disorder. The study is designed to support the early identification, early intervention, and prevention of mental health problems in youth populations.
The study adopts a three-arm parallel randomized controlled trial with a non-inferiority and superiority testing framework. Eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups: (1) the VIPeerAgent intervention group, (2) the human peer mentor support group, or (3) the usual-care control group.
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. Additional support will be provided through proactive follow-up and personalized content recommendations tailored to participants' psychological needs.
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. Participants in the usual-care control group will receive routine mental health education through weekly mental health promotion materials. The intervention period will last four weeks.
The primary outcome is improvement in mental health status during the follow-up period, assessed using the Brief Symptom Inventory-53 (BSI-53). Secondary outcomes include psychological resilience, coping strategies, perceived social support, and emotional intelligence.
In addition to the randomized controlled trial, an explanatory qualitative study will be conducted following completion of the intervention. Using purposive sampling, participants with diverse experiences and intervention responses will be invited to participate in semi-structured interviews. The qualitative interviews will explore participants' perceptions of the intervention, user experiences, acceptability, engagement, and perceived impact. Findings from the qualitative analysis will be used to complement and help explain the quantitative trial results, providing a deeper understanding of the mechanisms, benefits, and implementation considerations of AI-assisted peer support for youth mental health.
This design will generate comprehensive evidence regarding both the effectiveness and user experience of VIPeerAgent and inform the future development, implementation, and scalability of AI-supported mental health interventions for adolescents and young adults.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Wei Xia
- Telefonnummer: +8618823359471
- E-post: xiaw23@mail.sysu.edu.cn
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510080
- School of Nursing, Sun Yat-Sen University
-
Kontakt:
- Wei Xia
- Telefonnummer: +8618823359471
- E-post: xiaw23@mail.sysu.edu.cn
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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.
- Have a BSI-53 score <63.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: VIPeer Agent Intervention Group
|
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.
|
|
Aktiv komparator: Human peer mentor
|
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.
|
|
Inget ingripande: Usual Care control
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Level of Psychological Symptoms
Tidsram: 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.
|
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, 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Social Support
Tidsram: 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.
|
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, 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.
|
|
Stressful life events
Tidsram: 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.
|
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).
|
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.
|
|
Coping Strategies
Tidsram: 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.
|
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, 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.
|
|
Psychological Resilience
Tidsram: 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.
|
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, 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.
|
|
Emotional Intelligence
Tidsram: 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.
|
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.
A 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, 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- VIPA-RCT-2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .