- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06868303
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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
1300
Phase
- 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
- 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
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-
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Hong Kong, Hong Kong
- Recruiting
- Community
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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Active Comparator: eClinic User Group
This group receives the eClinic service provided by New Life Psychiatric Rehabilitation Association.
|
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.
|
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.
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Active Comparator: GP group
This group receives services provided by general practitioners.
|
Services provided by genersl practitioner
|
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Active Comparator: Hub Casework grpup
This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.
|
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.
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.
Services provided by genersl practitioner
Services provided during hub casework sessions
|
What is the study measuring?
Primary Outcome Measures
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
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)
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Baseline, 3-month, 6-month, and 12-month
|
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Change in Self-Esteem Level
Time Frame: Baseline, 3-month, 6-month, and 12-month
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Rosenberg Self-Esteem Scale (scores range from 0 to 30 where a higher score indicates a better outcome)
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Baseline, 3-month, 6-month, and 12-month
|
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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)
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Baseline, 3-month, 6-month, and 12-month
|
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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
Collaborators
Investigators
- 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)
May 6, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
March 7, 2025
First Submitted That Met QC Criteria
March 7, 2025
First Posted (Actual)
March 10, 2025
Study Record Updates
Last Update Posted (Actual)
June 6, 2025
Last Update Submitted That Met QC Criteria
June 3, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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