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临床试验/NCT07472894
NCT07472894尚未招募不适用

PEER MENTORING FOR ANXIETY AND DEPRESSION PRIMARY PREVENTION IN ADOLESCENTS AND YOUNG ADULTS

University of Patras2 个研究点 分布在 2 个国家目标入组 1,680 人开始时间: 2027年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,680
试验地点
2
主要终点
Revised Children Anxiety and Depression Scale (RCADS-25)

研究概览

简要总结

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

详细描述

Adolescence and young adulthood (12-25 years) represent critical developmental periods during which lifestyle patterns related to nutrition, physical activity, sleep, digital media use, social interaction, and stress regulation are consolidated and often persist into adulthood. Preventive interventions targeting these stages therefore offer substantial potential for long-term reduction of non-communicable disease (NCD) burden.

Although young people are often perceived as generally healthy, epidemiological evidence indicates a growing burden of NCD-related conditions in this population. More specifically, in terms of mental health conditions, anxiety and depressive disorders have risen sharply during the last decades, with depression rates among young people increasing by approximately 50% since 1990, contributing to impaired quality of life and increased risk of comorbid physical health problems. A substantial body of evidence links anxiety and depression risk to modifiable lifestyle and psychosocial behaviours established early in life, and behavioural interventions addressing these factors have demonstrated promising effects in young populations. However, existing interventions often show wide variability in design and outcomes and face persistent challenges related to long-term adherence, scalability, and equitable access. Many rely on professional-led delivery models requiring substantial human and financial resources, limiting their sustainability and reach, particularly in low-resource or geographically remote settings.

Digital health interventions have emerged as a promising means to improve accessibility and engagement while supporting self-monitoring and feedback. Digital approaches have demonstrated positive effects on behaviours related to physical activity, diet, sleep and stress management. Nevertheless, many digital interventions remain largely individualised and screen-centric, insufficiently leveraging the social environments in which young people's behaviours are embedded, which may limit sustained engagement and long-term behaviour change.

In this context, peer mentoring represents a promising, yet, underutilised approach for strengthening behavioural self-management and primary NCD prevention among adolescents and young adults. Peer mentoring involves structured, supportive relationships in which individuals with shared or similar lived experiences provide guidance, encouragement, and role modelling. During adolescence and young adulthood, peers exert a strong influence on attitudes, norms, motivation, and behaviour. Peer-led approaches are often perceived as more relatable, credible, and emotionally safe than authority- or expert-led interventions, fostering trust, social connectedness, and intrinsic motivation. Peer mentoring programmes have demonstrated effectiveness in promoting healthy behaviours and psychosocial outcomes in youth, particularly in school-based and community settings.

Peer mentoring aligns closely with contemporary self-management models by promoting active participation, shared responsibility, and empowerment rather than passive receipt of advice. In the context of NCD prevention, it can support the adoption and maintenance of health-promoting behaviours by embedding behaviour change within everyday social interactions and reinforcing positive social norms. Importantly, peer mentoring complements professional care, extending the reach and sustainability of preventive interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals aged 12-25 yrs old -

排除标准

  • Chronic mental health conditions, severe cognitive or communication deficits

研究组 & 干预措施

AI-informed peer-mentoring behavioral intervention

Experimental

A 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.

干预措施: Peer-mentoring behavioral intervention (Behavioral)

Standard peer-mentoring behavioral intervention

Active Comparator

A structured school-based (adolescents) or campus- or community- based (young adults) behavioral change intervention program delivered through peer-mentoring but without AI-support

干预措施: Peer-mentoring behavioral intervention (Behavioral)

Health educational intervention

Active Comparator

Regular health education sessions delivered by professionals

干预措施: Health Education (Other)

结局指标

主要结局

Revised Children Anxiety and Depression Scale (RCADS-25)

时间窗: From enrollment to intervention completion at 6 months

Assessment of anxiety and depressive symptoms in adolescents

Perceived Stress Scale (PSS-10)

时间窗: From enrollment to the end of the intervention at 6 months

Assessment of stress levels

SF36 Social functioning sub-scale

时间窗: From enrollment to study completion at 6 months

Assessment of social functioning

Depression Anxiety Stress Scale (DASS-21)

时间窗: From enrollment to study completion at 6 months

Assessment of anxiety, depressive and stress symptoms in young adults

Depression Anxiety Stress Scale Youth (DASS-Y)

时间窗: From enrollment to study completion at 6 months

Assessment of anxiety, depressive and stress symptoms in adolescents

KIDSCREEN-27 Social functioning sub-scale

时间窗: From enrollment to study completion at 6 months

Assessment of social functioning

次要结局

  • 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)
  • Sleep actigraphic data(From enrollment to study completion at 6 months)
  • Five Facet Mindfulness Questionnaire Short Form(From study enrollment to study completion at 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aikaterini Karaivazoglou

Assistant Professor of Child and Adolescent Psychiatry

University of Patras

研究点 (2)

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