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Идёт набор NCT06955195

Youth-for-Youth Mental Wellness Care and Action

Без фазы С лечением Mental Well-being Adolescent Health Mental Health Literacy School Difficulties Associated With Mental Health Problems

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: School-based intervention program on improving adolescent mental wellbeing, Control-no treatment.
Кому может быть актуально
Состояния в реестре: Mental Well-being, Adolescent Health, Mental Health Literacy, School Difficulties Associated With Mental Health Problems. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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).

Подробное описание

1\. Background

1. 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

1. To evaluate the effectiveness of the multi-faceted programme in promoting flourishing, quality of life, and understanding of mental health (e.g., mental health literacy) and help-seeking intention, reducing mental distress (e.g., depressive symptoms and suicidal ideation and attempt), and fostering positive social environments (e.g., social support, school climate-caring relationship, and sense of community) among secondary school students in Hong Kong. 2. To evaluate the students' process of change in psychological (e.g., mattering, self-efficacy, resilience, emotion-regulation, empowerment, and stress reduction) and social (e.g., trust belief and engagement) aspects and mental health awareness (e.g., mental health stigma and help-seeking attitudes) throughout the programme. 3. To evaluate the feasibility, acceptability, and sustainability of the programme implementation among local secondary schools, including understanding the experiences and perspectives of students and stakeholders using a mixed-method approach. 4. To evaluate the cost-effectiveness (e.g., the incremental cost-effectiveness ratio (ICER)) of delivering the programme among secondary schools in Hong Kong.

3\. Study design, randomization, and sample size planning The programme will employ a parallel cluster randomized controlled trial (RCT) alongside a quasi-experimental design, with secondary schools as the unit of allocation and individuals as the unit of analysis. A total of 130 secondary schools will be involved, comprising 40 pilot schools and 90 schools participating in the RCT. For the pilot schools, the quasi-experimental design will be conducted for pre- (T0) and post-intervention (T1) assessment with no control group. The RCT schools will be randomly assigned to the intervention or waitlist control conditions (ratio 1:1).

The randomization process of the cluster RCT will be conducted based on the geographical banding or districts of the schools, ensuring that each banding encompasses schools with similar demographic and socio-economic profiles. Schools within each band or district will be further stratified prior to randomization, based on factors like school size, student demographics, and resource availability, to ensure comparability. After that, a comprehensive list of schools within each band or district will then be randomly assigned to either the intervention or waitlist control group, using a computer-generated sequence. During the intervention, participants and program facilitators will not be blind to the allocation status due to the nature of the intervention. The RCT schools will be assessed at pre- (T0), post-intervention (T1), and 3-month follow-up (T2). The waitlist condition group (N=45) will implement the intervention after the T2 evaluation and be assessed another round of evaluation after implementing the intervention.

To estimate the number of RCT schools, students' flourishing will be the primary outcome of this programme. Based on Schalkwyk et al.'s well-being intervention for improving adolescents' flourishing, after the intervention, the mean difference of flourishing (measured by MHC-SF, as a continuous variable) between two groups was around 3 (SD 15). Assuming an intra-cluster correlation coefficient (ICC) is 0.07 \[0.05-0.10\] for flourishing outcome, which has been estimated for the mental well-being indicators among adolescents. If it is estimated that 200 students each school participate in the programme, to ensure 80% power and a 5% significance level, the number of school clusters will be 29 for each arm. Therefore, at least 58 schools are needed in the RCT phase and 26,000 students are roughly reached during the pilot and RCT phase.

4\. Target groups Local junior students in Form 1 to 3 from130 designated secondary schools in Hong Kong. The inclusion criteria include 1.) Chinese student in Hong Kong secondary school, 2.) Studying at Form 1 to Form 3 at the time of recruitment, 3.) Competence in comprehending written Chinese, and 4.) Competence in speaking Cantonese. Meanwhile, the exclusion criteria include 1.) Non-Chinese student, 2.) Not studying at Form 1 to 3 in Hong Kong secondary school, 3.) Incompetence in comprehending written Chinese, and 4.) Incompetence in speaking Cantonese.

5\. Recruitment, data collection, and ethical approval To ensure comprehensive coverage and diversity in the study sample, 130 secondary schools across the 18 districts of Hong Kong will be invited to the programme. The programme will be conducted in two phases spanning across 3 academic years. The first academic year serves as a pilot phase involving 40 secondary schools based on school geographical banding, where the intervention will be initially implemented and evaluated. The pilot phase includes pre- (T0) and post-intervention (T1) evaluations using questionnaires, alongside the participatory research with students, student leaders, and stakeholders among 20 schools. The pilot phase helps to test the intervention and evaluation are practical and applicable in real-world setting, and the participatory research gather and incorporate multiple perspectives to develop and improve the intervention tailored to youth's actual needs.

Following the pilot phase, the programme will incorporate a cluster RCT design with 90 secondary schools, which will be randomly assigned to either an intervention group or waitlist control group, with 45 schools in each. The intervention group will implement the intervention in the second academic year; evaluation will be conducted at schools in both groups at T0, T1, and 3-month follow-up (T2). After the follow-up evaluation, in the third academic year, the intervention will be extended to the waitlist control schools, ensuring equitable access to the intervention while maintaining the integrity of the RCT design; another round survey will

Вмешательства

  • Поведенческое School-based intervention program on improving adolescent mental wellbeing
    Students participating in the intervention program will attend the school talk and workshops about mental health. They are also required to organize whole-school activities to promote peer mental wellbeing at school. All attended students will be guided by registered social workers and trained research personnel throughout the intervention program.
  • Другое Control-no treatment
    Students participating at control group will not receive intervention program during the academic year compared with their counterparts in active comparator group. They will live and attend the class as usual at school. After the academic year, they will receive the intervention program on the alternative academic year.

Первичные конечные точки

  • Flourishing [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Depression and Anxiety [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Suicidal ideation and attempt [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Social support [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • School climate-caring relationship [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Sense of community [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Mental health literacy [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Help seeking intention [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Quality of life (EQ-5D-Y) [Срок оценки: From enrolment to the end of intervention program at 6 months]
  • Quality of life (CHU9D) [Срок оценки: From enrolment to the end of intervention program at 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Гонконг · 2 центра
  • Centre for Health Behaviours Research, JCSPHPC, CUHK — Гонконг
  • Centre for Health Behaviours Research, JCSPHPC, CUHK — Гонконг

Идентификаторы

NCT: NCT06955195 · SBRE-23-0724

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗