The Effectiveness of Mental Wellness Youth Hubs in Hong Kong

June 3, 2025 updated by: Dr. Christy Lai-ming Hui, The University of Hong Kong

A Quasi-controlled Study on the Effectiveness of Mental Wellness Youth Hubs in Hong Kong

This study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii) whether any particular subgroup(s) of youths (e.g., gender, socio-economic status, migrant status) may benefit more from this service model. The experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. The control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. The community cohort is accessible via the Youth Epidemiological Study Online platform (YES online), which recruits young people aged 12 to 24 years. Only YES online participants who are not using the service of LevelMind@JC and psychiatric medications will be recruited for this study. The two groups will be matched in age, gender, and baseline distress level measured by the 6-item Kessler Psychological Distress Scale (K6). There will also be a substudy assessing the effect of four service models: NLPRA eClinic, Integrated Community Centre for Mental Wellness (ICCMW) step-up care, general practitioners, and hub casework support service on symptom-based mental health outcome, comparing a cohort of young people receiving these four services respectively. A total of 252 participants will be recrruited. Another substudy will be conducted to investigate the extent to which participation in Tier 1 activities contributes to improvements in targeted outcome areas, assessing young people (n = 675) before and after their participation of Tier 1 activities. A consecutive sampling will be used, where a subject who meets the criteria of inclusion will be selected until this required sample size is achieved.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Christy Lai Ming Hui, PhD
  • Phone Number: +852 2255 4486
  • Email: christy@lmhui.com

Study Contact Backup

  • Name: Yi Nam Suen, PhD
  • Phone Number: +852 3917 6612
  • Email: suenyn@hku.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Community

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • For hub user group: 12- to 24-year-old hub users who receive community-based mental wellness youth hub services for young people.
  • For community control group: 12- to 24-year-old community youths who do not receive any youth services in the community.
  • For eClinic user group: 12- to 24-year-old eClinic service users.

Exclusion Criteria:

  • Youths with known diagnosis of psychiatric disorders (including Depression, Generalized Anxiety Disorder, Panic Disorder, Phobia, Obsessive Compulsive Disorder, Bipolar Disorder, Eating Disorder, Personality Disorder, Post-Traumatic Stress Disorder and Psychotic Disorder)
  • Youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hub User Group
This group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being.
Behavioral: LevelMind@JC Mental Wellness Youth Hubs
Mental Wellness Youth Hubs Intervention aims to set up a series of community-based hubs for young people to enhance cognitive abilities, personal strengths and overall mental well-being. Among the experimental group participants (hub users), they are further divided into three tiers according to their psychological distress level. Tier 1 are youths with mild psychological distress level, who will be invited to participate in some innovative and interesting youth projects and activities (e.g., board game and floral artistry). Tier 2 are youths who have moderate level of psychological distress, or at risk for mental illness. Trained social workers will offer them with specific interventions (e.g., CBT, sleep intervention) according to their needs. Tier 3 are youths with severe level of psychological distress who are at risk for mental disorders. Diagnostic and medical assessment services will be delivered by psychiatrist or clinical psychologists.
No Intervention: Non-hub User Community Control Group
This group does not receive any youth services in the community.
Active Comparator: eClinic User Group
This group receives the eClinic service provided by New Life Psychiatric Rehabilitation Association.
Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service
The eClinic treatment spans eight to fourteen week and is designed for individuals with moderate to severe mental health issues. The service is provided in a hybrid format, incorporating an in-person initial screening using the Patient Health Questionnaire-9 and General Anxiety Disorder-7, followed by online self-learning resources and sessions with a therapist. Pre- and post-treatment assessments as well as follow-ups will be used to keep track of service users' progress.
Active Comparator: ICCMW group
This group receives the eClinic service provided by Integrated Community Centre for Mental Wellness (ICCMW) step-up care.
Behavioral: Integrated Community Centres for Mental Wellness
Integrated Community Centres for Mental Wellness (ICCMWs) are the main community-based mental health services in Hong Kong. However, their reach among young people is limited, as their broad target age range primarily focuses on middle-aged individuals. ICCMW offers comprehensive, district-based community support and social rehabilitation services, from early prevention to risk management, for people in mental recovery, those with suspected mental health issues, their families and carers, and residents within the service area, all accessible through a single-entry point.
Active Comparator: GP group
This group receives services provided by general practitioners.
Other: General Practitioner
Services provided by genersl practitioner
Active Comparator: Hub Casework grpup
This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.
Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service
The eClinic treatment spans eight to fourteen week and is designed for individuals with moderate to severe mental health issues. The service is provided in a hybrid format, incorporating an in-person initial screening using the Patient Health Questionnaire-9 and General Anxiety Disorder-7, followed by online self-learning resources and sessions with a therapist. Pre- and post-treatment assessments as well as follow-ups will be used to keep track of service users' progress.
Behavioral: Integrated Community Centres for Mental Wellness
Integrated Community Centres for Mental Wellness (ICCMWs) are the main community-based mental health services in Hong Kong. However, their reach among young people is limited, as their broad target age range primarily focuses on middle-aged individuals. ICCMW offers comprehensive, district-based community support and social rehabilitation services, from early prevention to risk management, for people in mental recovery, those with suspected mental health issues, their families and carers, and residents within the service area, all accessible through a single-entry point.
Other: General Practitioner
Services provided by genersl practitioner
Behavioral: Hub Casework
Services provided during hub casework sessions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Psychological Distress
Time Frame: Baseline, 3-month, 6-month, and 12-month
The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Well-being
Time Frame: Baseline, 3-month, 6-month, and 12-month
The World Health Organization-Five Well-Being Index (scores range from 0 to 25 where a higher score indicates a better outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Quality of Life
Time Frame: Baseline, 3-month, 6-month, and 12-month
The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)
Baseline, 3-month, 6-month, and 12-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function
Time Frame: Baseline, 3-month, 6-month, and 12-month
Digit Span Test
Baseline, 3-month, 6-month, and 12-month
Change in Depressive, Anxiety, and Stress Levels
Time Frame: Baseline, 3-month, 6-month, and 12-month
The 21-item Depression Anxiety Stress Scales (scores range from 0 to 63 where a higher score indicates a worse outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Social and Occupational Functioning
Time Frame: Baseline, 3-month, 6-month, and 12-month
Social and Occupational Functioning Assessment Scale (scores range from 0 to 100 where a higher score indicates a better outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Sleep Quality
Time Frame: Baseline, 3-month, 6-month, and 12-month
Pittsburgh Sleep Quality Index (scores range from 0 to 21 where a higher score indicates a worse outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Physical Exercise
Time Frame: Baseline, 3-month, 6-month, and 12-month
The International Physical Activity Questionnaire (classify physical activity level into three categories: low, moderate, and high)
Baseline, 3-month, 6-month, and 12-month
Change in Self-Esteem Level
Time Frame: Baseline, 3-month, 6-month, and 12-month
Rosenberg Self-Esteem Scale (scores range from 0 to 30 where a higher score indicates a better outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Psychological Resilience
Time Frame: Baseline, 3-month, 6-month, and 12-month
The 10-item Connor-Davidson Resilience Scale (scores range from 0 to 40 where a higher score indicates a better outcome)
Baseline, 3-month, 6-month, and 12-month
Change in Health Economics
Time Frame: Baseline, 3-month, 6-month, and 12-month
Client Service Receipt Inventory
Baseline, 3-month, 6-month, and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Hong Kong Jockey Club Charities Trust
Hong Kong Young Women's Christian Association
Caritas Medical Centre, Hong Kong
Tung Wah Group of Hospitals
The Salvation Army, Hong Kong and Macau Command
Hong Kong Christian Service
Hong Kong Sheng Kung Hui Welfare Council Limited
New Life Psychiatric Rehabilitation Association
The Boys' and Girls' Clubs Association of Hong Kong
Yan Oi Tong
Chinese YMCA of Hong Kong
Hong Kong Playground Association (HKPA)
Hong Kong Children and Youth Services (HKCYS)
Hong Kong Federation of Youth's Group (HKFYG)
Chinese Young Men's Christian Association of Hong Kong
Neighbourhood Advice-Action Council
St. James' Settlement

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christy Lai Ming Hui, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20250221-005-000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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