AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN YOUTH
PeerMentorAnxD
PEER MENTORING FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN ADOLESCENTS AND YOUNG ADULTS
1 other identifier
interventional
1,680
2 countries
2
Brief Summary
The goal of this clinical trial will be to evaluate the efficacy of an AI-informed peer-mentoring program to improve stress management and social skills and reduce the risk of depressive and anxiety symptoms in healthy adolescents (12-18 years old) and young adults (18-25 years old). The main question it aims to answer is whether the peer-mentoring behavioral intervention will achieve the desired behavioral changes and reduce the emergence of anxiety and depression symptoms. Researchers will compare the AI-informed peer-mentoring behavioral intervention program with a standard peer-mentoring program and a standard health educational program. Some study participants will be trained to be peer mentors and subsequently they will be paired with slightly younger mentees and they will attend shared activities for an academic year
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2027
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
September 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
April 14, 2026
April 1, 2026
1.3 years
March 7, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Perceived Stress Scale (PSS-10)
Assessment of stress levels
From enrollment to the end of the intervention at 6 months
Revised Children Anxiety and Depression Scale (RCADS-25)
Assessment of anxiety and depressive symptoms in adolescents
From enrollment to intervention completion at 6 months
Depression Anxiety Stress Scale (DASS-21)
Assessment of anxiety, depressive and stress symptoms in young adults
From enrollment to study completion at 6 months
Depression Anxiety Stress Scale Youth (DASS-Y)
Assessment of anxiety, depressive and stress symptoms in adolescents
From enrollment to study completion at 6 months
KIDSCREEN-27 Social functioning sub-scale
Assessment of social functioning
From enrollment to study completion at 6 months
SF36 Social functioning sub-scale
Assessment of social functioning
From enrollment to study completion at 6 months
Secondary Outcomes (7)
KIDSCREEN-27
From enrollment to intervention completion at 6 months
Salivary cortisol levels
From enrollment to intervention completion at 6 months
Screen-time self-reported questionnaire
From enrollment to intervention completion at 6 months
Pittsburgh Sleep Quality Index AYA version
From enrollment to intervention completion at 6 months
Screen-time mobile tracking device
From enrollment to study completion at 6 months
- +2 more secondary outcomes
Study Arms (3)
AI-informed peer-mentoring behavioral intervention
EXPERIMENTALA structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring and supported by AI-informed tools, focusing on stress management and social competence. The intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence.
Standard peer-mentoring behavioral intervention
ACTIVE COMPARATORA structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring but without AI-support
Health educational intervention
ACTIVE COMPARATORRegular health education sessions delivered by professionals
Interventions
The intervention' s content will be based on existing evidence-based interventions, namely the Mindfulness-based Stress Reduction program which enhances stress management and the Positive Youth Development Framework which strengthens social and emotional skills and facilitates social competence.
Health education sessions delivered by professionals focusing on stress management and social skills
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Patraslead
- Modena Health Authoritycollaborator
- University of Bolognacollaborator
- 6th Hellenic Health Districtcollaborator
Study Sites (2)
University Hospital of Patras
Pátrai, Greece
Modena Health Authority
Modena, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Child and Adolescent Psychiatry
Study Record Dates
First Submitted
March 7, 2026
First Posted
March 16, 2026
Study Start (Estimated)
September 1, 2027
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After publication of study results
- Access Criteria
- Researchers
IPD will be anonymized and will be entered in databases available to researchers