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AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN YOUTH

ConditionAnxiety Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorUniversity of Patras

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peer-mentoring behavioral intervention

    Behavioral

    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

    Other intervention

    Health education sessions delivered by professionals focusing on stress management and social skills

Treatment groups

1,680 Participants
are divided into 3 treatment groups
Group A: AI-informed peer-mentoring behavioral interventionExperimental treatment 1 intervention
Group B: Standard peer-mentoring behavioral interventionActive comparator 1 intervention
Group C: Health educational interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Perceived Stress Scale (PSS-10)

Assessment of stress levels

Time frame
From enrollment to the end of the intervention at 6 months
2

Revised Children Anxiety and Depression Scale (RCADS-25)

Assessment of anxiety and depressive symptoms in adolescents

Time frame
From enrollment to intervention completion at 6 months
3

Depression Anxiety Stress Scale (DASS-21)

Assessment of anxiety, depressive and stress symptoms in young adults

Time frame
From enrollment to study completion at 6 months
4

Depression Anxiety Stress Scale Youth (DASS-Y)

Assessment of anxiety, depressive and stress symptoms in adolescents

Time frame
From enrollment to study completion at 6 months

Secondary outcomes

1

KIDSCREEN-27

Assessment of quality of life in adolescents

Time frame
From enrollment to intervention completion at 6 months
2

Salivary cortisol levels

Assessment of HPA activity

Time frame
From enrollment to intervention completion at 6 months
3

Screen-time self-reported questionnaire

Assessment of screen-time

Time frame
From enrollment to intervention completion at 6 months
4

Pittsburgh Sleep Quality Index AYA version

Assessment of sleep quality

Time frame
From enrollment to intervention completion at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Patras

Lead sponsor

Modena Health Authority

Collaborator

University of Bologna

Collaborator

6th Hellenic Health District

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: