NCT06955195RecruitingNot Applicable

Youth-for-Youth Mental Wellness Care and Action

Chinese University of Hong Kong1 site in 1 country18,000 target enrollmentStarted: August 21, 2025Last updated: May 29, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Chinese University of Hong Kong
Enrollment: 18,000
Locations: 1
Primary Endpoint: Flourishing

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

This initiative aims to improve flourishing and quality of life of secondary school students, reduce mental distress (e.g., depression and suicidal ideation), enhance their understanding of mental health (e.g., mental health literacy) and help-seeking intention, and foster a supportive school environment (e.g., school climate-caring relationship, and sense of community). Also, this initiative aims to improve students' process of change in psychological (e.g., mattering, emotion regulation, empowerment) and social (e.g., trust belief) aspects and mental health awareness (e.g., mental health stigma). The feasibility, acceptability, and sustainability of the programme from multiple perspectives (e.g., students, student leaders, and stakeholders) will also be evaluated. In addition, the cost-effectiveness of delivering this programme (e.g., the incremental cost-effectiveness ratio (ICER)) among secondary schools in Hong Kong will be assessed.

The programme will be implemented among students in 130 local secondary schools over three academic years. The first is a pilot phase (Year 1), which 40 schools will implement the intervention and student participants will be evaluated at pre- (T0) and post-intervention (T1) using questionnaires. In this stage, participatory research will be conducted before and after the intervention among students, student leaders, and stakeholders in 20 pilot schools to co-design the intervention, ensuring the programme meet the actual wellness needs of youth. In following two academic years, an additional 90 schools will participate in a cluster randomized controlled trial (RCT) with a 1:1 ratio between intervention and waitlist control groups. Each year, 45 schools will implement the intervention. Summative evaluation will be conducted among RCT schools at T0 and T1, and 3-month follow-up (T2). Quantitative data be collected to assess the effectiveness of intervention, and qualitative data will provide understanding of students' and stakeholders' perspectives of the intervention implementation. Cost outcomes will include intervention costs and cost savings, calculated from the payer (i.e., JC/government) perspective using administrative records or validated tools. The primary outcome of cost-effectiveness will be the quality-adjusted life-years (QALYs) of students. Cost of implementing the intervention program and QALYs will be used to evaluate the cost-effectiveness of the intervention, for example, estimate the incremental cost-effectiveness ratio (ICER).

Detailed Description

1. Background

Improving mental wellness of adolescents in Hong Kong has important and far-reaching significance Mental health issues have significant impact on children and adolescents worldwide, particularly with a young onset. Among these issues, anxiety and depression are the most reported and are among the top ten causes of disability-adjusted life-years for individuals aged 10-24 years (Collaborators, 2020; Fusar-Poli, 2019; Kessler et al., 2005). The prevalence of anxiety and depression has been steadily increasing over the past few decades. In Hong Kong, a study involving 9,518 secondary school students revealed a moderate to severe levels of depression, as measured by the Center for Epidemiological Studies-Depression (CES-D) (Wu et al., 2016). Additionally, another study conducted among 3,136 secondary school students in Hong Kong found that 54.3% and 65,8% of both males and females scored above the cut-off for mild depression, as assessed by the CES-D (She et al., 2021). Specifically, 54.3% of males and 65.8% of females surpassed the cut-off. It is crucial to address these challenges and provide appropriate resources and interventions to promote mental well-being among children and adolescents.

The significance of mental health problems among adolescents cannot be overstated. Adolescence is a critical period of development, marked by numerous physical, emotional, and social changes. Mental health problems during this stage can have long-lasting effects on the individual's overall well-being and future trajectory. These issues not only impact the affected adolescents themselves but also have far-reaching consequences for their families, communities, and society. Extensive evidence has shown that anxiety and depression are associated with significant adverse consequences among adolescents, such as substance abuse, poor physical health, underachievement in schools, harmful social outcomes, and subsequent depression in later life, (Johnson et al., 2018; Ranasinghe et al., 2016). Moreover, they may induce long-term effects throughout life, and even affect the mental health of offspring (Avenevoli & Merikangas, 2006; Clayborne et al., 2019; Collishaw et al., 2016; Vismara et al., 2022). Recognizing and addressing mental health problems among adolescents is vital to ensure their healthy and successful transition into adulthood and to foster a resilient and thriving society.

More importantly, mental health issues increase risk of suicide which is a serious public health issue. Suicide-related behaviors are common among school-aged adolescents. According to the World Health Organization, suicide is the fourth leading cause of young people aged 15-29 (World Health Organization, 2023). In Hong Kong, the suicide rate among those aged 15-24 rose to 12.2 deaths per 100,000 people in 2022, compared with 6.2 per 100,000 in 2014 (South China Morning Post, 2023). It is believed that the suicide rate is under-reported in many countries due to the inferior death classification system, and the cultural and religious beliefs that may affect individual's views towards suicide (Beautrais et al., 2006). Losing a young life not only results in a significant societal loss but also inflicts immense psychological suffering upon their families (Goldsmith et al., 2002). Moreover, the unfortunate act of suicide can have a copycat effect, particularly when sensationalized by the media, which is especially prevalent in Asian countries (Chen et al., 2010). Interventions that promotes mental health among adolescents are of utmost importance, seeking to provide support and assistance to those at risk, ultimately saving lives and mitigating the devastating impact on individuals, families, and communities. 2. The need for youth-centered and school-based initiatives for youth's mental wellness Promoting mental health among adolescents is a significant challenge as many adolescents who have mental health problems are disinclined to seek help (Platell et al., 2020). Despite the availability of mental health program in the community, they are difficult to reach those at-risk youth to provide resources and support (Bradby et al., 2007; French et al., 2003). Numerous barriers to mental health support utilization are identified and include the lack of awareness of mental health issues (French et al., 2003), fear of stigma (Bradby et al., 2007), reliance of self-coping (Burgess et al., 2020), perceived ineffectiveness of mental health services (Platell et al., 2020), and fear of the possible consequences of the loss of privacy (Bradby et al., 2007). Additionally, there have also been critics that existing mental health programs are disconnected from their lived experience and fail to address their specific needs, which can lead to disengagement and lack of trust (Georgiadis et al., 2020). To increase acceptability of mental health services, it is important that adolescent mental health programs should be youth-centered. By prioritizing the perspectives, experiences, and needs of adolescents, mental health programs can be tailored and relevant to their unique challenges and circumstances, promoting better engagement and participation (Georgiadis et al., 2020). Also, actively involving adolescents in the planning, design, and implementation of mental health initiatives can promote empowerment them and give them a sense of ownership over their own well-being (Freire et al., 2022). By recognizing the agency of adolescents and involving them in decision-making processes, we can create a more comprehensive and holistic approach to adolescent mental health that addresses their specific needs, ultimately leading to better outcomes and improved overall well-being (Freire et al., 2022). Furthermore, school-based programme is recommended for adolescents as it can provide an easy ongoing access to them (Kern et al., 2017). As adolescents spend most of their time in the school, school-based programme is considered one of the most effective ways to promote mental health and help-seeking among adolescents (Kern et al., 2017).

2. Objectives

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Health Services Research
Masking: None

Eligibility Criteria

Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•student in Hong Kong secondary school
•Studying at Form 1 to Form 3 at the time of recruitment
•Competence in comprehending written Chinese or English
•Competence in speaking Cantonese or English
•Written consent from students and their legal guardian

Exclusion Criteria

•Not studying at Form 1 to 3 in Hong Kong secondary school
•Incompetence in comprehending written Chinese or English
•Incompetence in speaking Cantonese or English
•No written consent from students or their legal guardian

Arms & Interventions

Receiving school-based intervention program on adolescent mental wellbeing

Active Comparator

Students at secondary school receiving school-based intervention program on adolescent mental wellbeing during a academic year. They will complete the questionnaires before and after the intervention program at their first year.

Intervention: School-based intervention program on improving adolescent mental wellbeing (Behavioral)

Receiving school-based intervention program on adolescent mental wellbeing

Active Comparator

Intervention: Control-no treatment (Other)

Not receiving school-based intervention program on adolescent mental wellbeing

No Intervention

Students at secondary school not receiving school-based intervention program on adolescent mental wellbeing during the first academic year. They will complete the questionnaires before and after the active comparator's intervention program at their first year. In addition, they will receive the intervention program and complete the questionnaires before and after the said intervention program during the second academic year.