NCT06955195

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 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Aug 2025Dec 2027

First Submitted

Initial submission to the registry

April 23, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 21, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

April 23, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

MENTAL HEALTHADOLESCENT MENTAL HEALTHSCHOOL CLIMATE ON MENTAL HEALTHMENTAL HEALTH FRIENDLY CAMPUSMENTAL HELP-SEEKING BEHAVIORMENTAL HEALTH LITERACY

Outcome Measures

Primary Outcomes (22)

  • Flourishing

    Students' psychological wellbeing is measured by the Mental Health Continuum-Short Form (MHC-SF). It is a 14 items validated measure for Chinese adolescent. Each item is scored from 0 (Never) to 5 (every day). Among the 14 items, 3 are emotional well-being questions and 11 are positive functioning questions. Adolescents are considered to be "flourishing" if they score 4 or above to at least 1 of the emotional questions and to at least 6 of the positive functioning questions; considered to be "languishing" if they score 1 or below to 1 or more of the 3 emotional questions and to 6 or more of the 11 positive functioning questions; considered to have "moderate mental health" if they are neither flourishing nor languishing.

    From enrolment to the end of intervention program at 6 months

  • Depression and Anxiety

    Depression and anxiety will be assessed with the 4-item Patient Health Questionnaire-4 (PHQ-4), an ultra-brief self-report questionnaire that consists of a 2-item anxiety scale (GAD-2) and a 2-item depression scale (PHQ-2). The PHQ-2 consists of the two core criteria for depressive disorders, with the two items determining depression and the two items of the GAD-2 assess the core criteria for generalized anxiety disorders. This tool has been validated and used in adolescent populations. Each item of this 4-item survey is graded on a 4-point Likert scale scoring from 0 (Not at all) to 3 (Nearly every day). The total score of each part is 6. Scale scores of ≥3 was suggested as cut-off points between the normal range and probable cases of depression or anxiety respectively PHQ-4 scores go from normal (0 -2), mild (3-5), moderate (6-8) to severe (9 -12).

    From enrolment to the end of intervention program at 6 months

  • Suicidal ideation and attempt

    Suicidal ideation and attempt will be assessed by 2 questions from the PHQ-A, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?"

    From enrolment to the end of intervention program at 6 months

  • Social support

    A 3-item subscale of the Comprehensive Inventory of Thriving (CIT) will be employed to measure the level of social support perceived from the environment for adolescents. Each item of the subscale is graded on a 5-point Likert scale scoring from 1 (Strongly disagreed) to 5 (Strongly agreed). The three questions are 'There are people I can depend on to help me', 'There are people who give me support and encouragement' and 'There are people who appreciate me as a person'. Higher score indicates higher level of perceived social support.

    From enrolment to the end of intervention program at 6 months

  • School climate-caring relationship

    The availability of caring persons for students will be measured by three items of caring relationship measure from the California Healthy Kids Resilience Module. Items include presence of an adult who "cares about me", "notices when I am not there", "who listens to me when I have something to say", each item are rating on a 4-point scale.

    From enrolment to the end of intervention program at 6 months

  • Sense of community

    Sense of community (SOC) will be assessed by the 8-item Brief sense of community scale (BSCS) for adolescents. Each item of the scale is graded on a 5-point Likert type scoring from 1 (Strongly disagreed) to 5 (Strongly agreed). Four domains of the scales include Needs Fulfilment (items 1 and 2), Group Membership (items 3 and 4), Influence (items 5 and 6), and Emotional Connection (items 7 and 8). The score of each domain is calculated by taking the mean of the items. Higher score indicates higher level of perceived sense of community.

    From enrolment to the end of intervention program at 6 months

  • Mental health literacy

    Mental health literacy will be measured by 9 items from the Mental Health Literacy Scale. The scale assesses individuals' understanding on the various aspect of mental health. In the present study, 9 items that are related to understanding of depression, anxiety, and professional help-seeking will be selected. Items are rated on a 4-point Likert Scale from 1 (very unlikely) to 4 (very likely).

    From enrolment to the end of intervention program at 6 months

  • Help seeking intention

    The willingness to seek help if they encounter mental health problems is assessed with the General Help-Seeking Questionnaire. It asks how likely it for students is to seek help from a list of people (such as their peers, sisters or brothers in schools) for personal or emotion problems, from 1 (Extremely unlikely) to 7 (Extremely likely).

    From enrolment to the end of intervention program at 6 months

  • Quality of life (EQ-5D-Y)

    The EQ-5D Youth Version (EQ-5D-Y) is a generic, child-friendly self-complete instrument measuring HRQoL in children and adolescents aged 8 to 15 years. Its design is based on the EQ-5D-3L instrument, which was developed to measure HRQoL in adults. It evaluates five dimensions of health-related quality of life: mobility, self-care, participation in usual activities, pain/discomfort, and anxiety/depression. Each dimension of EQ-5D-Y is measured across three levels of severity, from "no problems" to "having a lot of problems". This instrument has been validated and used among adolescent population in Hong Kong, however, its value set has not yet been derived in the local context.

    From enrolment to the end of intervention program at 6 months

  • Quality of life (CHU9D)

    The CHU9D has been validated for its sensitivity in capturing the effectiveness of health interventions among children and adolescents, with age range from 7 to 17 years. It encompasses nine dimensions: worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, and activities, each with five-level responses. The Chinese version of CHU9D has also been validated in a school-based sample in mainland China. The instrument has not been validated among Hong Kong adolescents, and we can examine its reliability and validity in this evaluation.

    From enrolment to the end of intervention program at 6 months

  • quality-adjusted life-years (QALYs)

    In this evaluation, the dual approach allows us to capture a broader health dimensions relevant to the adolescent population, and both instruments will be used to estimate the quality-adjusted life-years (QALYs) of secondary students for evaluating the programme's effectiveness. Responses from the CHU9D will be transformed into QALYs weights derived from a UK general population sample using an algorithm developed by Stevens, producing a utility value set of between 0.33 (worst health state) and 1 (best health state), and a utility score of zero denotes death.

    From enrolment to the end of intervention program at 6 months

  • Mattering

    Mattering refers to the perception of importance, significance and being valued by others. It is measured by the General Mattering Scale (GMS). It is a 5-items scales that asks questions such as "How important do you feel you are to other people?" and "How much do other people depend on you?". Each item is rated from 1 (Not at all) to 4 (A lot).

    From enrolment to the end of intervention program at 6 months

  • Hope

    Hope is defined as an indicator of psychological resilience and positive future orientation. The 6-item Snyder's State Hope Scale will be used here to assess how participants hold the belief in own capacity to initiate and sustain actions (agency) as well as the belief in own capacity to generate routes (pathways) to reach their goal. Each item of the scale is graded on an 8-point Likert type scoring from 1 (Definitely false) to 8 (Definitely true). Two domains of the scales include Agency (items 2, 4 and 6), and pathways (items 1, 3 and 5). Subscale scores for agency or pathways are derived by adding the three even- and odd-numbered items, and the total score of State Hope Scale is the sum of all six items.

    From enrolment to the end of intervention program at 6 months

  • Resilience

    The two-item version of the Connor-Davidson Resilience Scale (CD-RISC2) will be used to measure the ability to cope with stress and adverse effects of traumatic events. The total score is calculated by the average of the two items.

    From enrolment to the end of intervention program at 6 months

  • Emotion Regulation

    The use of emotion regulation strategies: cognitive reappraisal and expressive suppression is measured with the Emotion Regulation Questionnaire (ERQ-9). It is a 9-items questionnaire rated from 1 (Strongly disagree) to 7 (Strongly agree). Example statements are "I control my emotions by not expressing them." "When I'm faced with a stressful situation, I make myself think about it in a way that helps me stay calm."

    From enrolment to the end of intervention program at 6 months

  • Empowerment

    The Self-subscale of the Youth Empowerment Scale-Mental Health (YES-MH) consists of 7 items used to measure the extent to which students are encouraged to take an active role in managing their mental health. Sample items included "I know how to take care of my mental or emotional health".

    From enrolment to the end of intervention program at 6 months

  • Perceived Stress

    Stress level is measured by the 4-items Perceived Stress Scale (PSS-4). It consists of items such as "How often have you felt that you were unable to control the important things in your life?" and "How often have you felt that things were going your way?" and is rated with a point scale ranging from 1 to 5.

    From enrolment to the end of intervention program at 6 months

  • Trust belief

    Trust belief will be measured by the General Trust Questionnaire. It contains 6 items that measure individuals' beliefs about honesty and trustworthiness of others. In the present study, participants will be asked to evaluate the items with references to the people in their school. Items are rated on a 5-point Likert Scale, from 1 (strongly disagree) to 5 (strongly agree). Sample items are "Most people in the school are trustworthy."

    From enrolment to the end of intervention program at 6 months

  • Engagement

    Students' engagement in the program will be measured by the Tiffany-Eckenrode Program Participation Scale (TEPPS). The "Voice/Influence" 4-items subscale is selected, each item is rated from 1 (Not at all) to 5 (Very true for me). Examples are "I feel I have a lot of voice/power to influence decisions about the program." "I am very involved in the program activities."

    From enrolment to the end of intervention program at 6 months

  • Sense of Place

    Sense of place will be assessed by the 11-item self-report Place Subscale of Sense of Place Scale. Items 1-3 measure the emotional bond whereas items 4-7 measure the continuity as a sub-dimension of place identity. Item 8 reflects the importance of the place in supporting important or desired activities and goals. Item 9 measure the place dependence. Items 10 and 11 assess the memories of the place. A 5-point rating scale ranging from 1 (strongly disagree) to 5 (strongly agree) was used. Total score is the summation of all items from the subscale. Higher score indicates the higher level of perceived sense of place.

    From enrolment to the end of intervention program at 6 months

  • Mental health stigma

    The Peer Mental Health Stigmatization Scale-Revised (PMHSS-R) has 11 statements which are rated on a 5-point Likert scale, 1 (Disagree completely) to 5 (Agree completely).

    From enrolment to the end of intervention program at 6 months

  • Help seeking attitudes

    The Self-Stigma of Seeking Help (SSOSH) scale consists of 10 items that measure attitudes toward and intent to seek psychological help. It is rated on a 5-point scale. Examples are "I would feel okay about myself if I made the choice to seek professional help" and "Seeking psychological help would make me feel less intelligent".

    From enrolment to the end of intervention program at 6 months

Study Arms (2)

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.

Behavioral: School-based intervention program on improving adolescent mental wellbeingOther: Control-no treatment

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.

Interventions

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.

Receiving school-based intervention program on adolescent mental wellbeing

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.

Receiving school-based intervention program on adolescent mental wellbeing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Health Behaviours Research, JCSPHPC, CUHK

Hong Kong, HONG KONG, 00000, Hong Kong

RECRUITING

Centre for Health Behaviours Research, JCSPHPC, CUHK

Hong Kong, HONG KONG, 00000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Phoenix Kit Han Mo, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR
  • Winnie Wing Sze Mak, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Phoenix Kit Han Mo, PhD

CONTACT

Calvin Lam, MSocSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2025

First Posted

May 2, 2025

Study Start

August 21, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The overall results of masked IPD can be shared upon request made to the study principal investigator.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The IPD and supporting information will be available from beginning the 1st year and ending 3 years after the publication of results.
Access Criteria
A formal non-commercial study proposal must be made in writing to the study principal investigator and the detailed use and analysis of the IPD have to be described.

Locations