Youth-for-Youth Mental Wellness Care and Action

NCT06955195 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18000

Last updated 2025-08-28

No results posted yet for this study

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 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).

Conditions

  • Mental Well-being
  • Adolescent Health
  • Mental Health Literacy
  • School Difficulties Associated With Mental Health Problems
  • Mental Health Help-Seeking

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

  • New Life Psychiatric Rehabilitation Association

    collaborator OTHER
  • The University of Hong Kong

    collaborator OTHER
  • The Hong Kong Jockey Club Charities Trust

    collaborator OTHER
  • College of Professional and Continuing Education, The Hong Kong Polytechnic University

    collaborator UNKNOWN
  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Phoenix Kit Han Mo, PhD · Chinese University of Hong Kong

  • Winnie Wing Sze Mak, PhD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2027-08-31
Completion
2027-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955195 on ClinicalTrials.gov