NCT06955195

Youth-for-Youth Mental Wellness Care and Action

Recruiting now NA Last updated 28 August 2025

What this trial tests

NA trial testing School-based intervention program on improving adolescent mental wellbeing in Mental Well-being in 18,000 participants. Currently enrolling.

Timeline

21 August 2025

Primary endpoint
31 August 2027

31 December 2027

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	18,000
Start date	21 August 2025
Primary completion	31 August 2027
Estimated completion	31 December 2027
Sites	2 locations across Hong Kong

Drugs / interventions tested

• School-based intervention program on improving adolescent mental wellbeing
• Control-no treatment — full drug profile →

Conditions studied

• Mental Well-being — all drugs for Mental Well-being →
• Adolescent Health — all drugs for Adolescent Health →
• Mental Health Literacy — all drugs for Mental Health Literacy →
• School Difficulties Associated With Mental Health Problems — all drugs for School Difficulties Associated With Mental Health Problems →

Sponsor

Chinese University of Hong Kong

Who can join

Eligibility, any sex, with Mental Well-being or Adolescent Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 effectiveness will be the quality-adjusted life-years (QALYs) of students. Cost and QALYs will be used to evaluate the cost-effectiveness of the intervention, for example, estimate the incremental cost-effectiveness ratio (ICER).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.