- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840303
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub
June 27, 2023 updated by: Professor Eric Y.H. Chen, The University of Hong Kong
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hubs
The proposed study is to be carried out with 6000-7000 youths aged 12 - 24 in Hong Kong.
The purpose of the study is to investigate the effectiveness and cost-effectiveness of a Hub project for young people: LevelMind@JC.
This study is conducted by LevelMind@JC in collaboration with partnering NGOs including the Boys' & Girls' Clubs Association of Hong Kong (BGCA), Caritas Hong Kong, Hong Kong Federation of Youth's Group (HKFYG), Hong Kong Playground Association (HKPA), Hong Kong Children and Youth Services (HKCYS) and St James' Settlement (SJS).
It is a 1-year quasi experimental controlled study which aims to examine if these hubs can enhance young people's cognitive abilities, personal strengths and overall mental well-being.
1800 participants would be recruited, including 600 Hub users, 600 non-hub users (but receiving services from participating NGOs), and 600 community youth not receiving any youth services.
Participants will be assessed at baseline and follow-ups (e.g., 3 months, 6 months, and 12 months); completing questionnaires and answering questions during a 3- hour interview.
Hub users with mild to moderate mental distress will receive different psychological treatments according to their needs.
For youths who are at risk for mental disorders, diagnostic and medical assessment services will be delivered by psychiatrists or clinical psychologists.
Findings will allow us to better understand the effectiveness of this kind of community-based hubs for young people, improve mental wellness training of youth social workers; and in a long run, develop a community-based support model that is sustainable, scalable and replicable.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1800
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: Yi Nam Suen, PhD
- Phone Number: 39179579
- Email: suenyn@hku.hk
Study Contact Backup
- Name: Christy Lai Ming Hui, PhD
- Phone Number: 39179579
- Email: christy@lmhui.com
Study Locations
-
-
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Hong Kong, Hong Kong
- Recruiting
- Department of Psychiatry, The University of Hong Kong
-
Contact:
- Christy Lai Ming Hui, PhD
- Email: christy@lmhui.com
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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
12 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- For hub-user group (experimental group): 12 - 24 year- old hub users who receive community-based mental wellness youth hub services for young people.
- For non-hub user group (active control group): 12 -24 year- old youths who do not receive the community-based mental wellness youth hub services but other generic youth services in the community.
- For non-hub user group (passive control group): 12 -24 year- old community youth who do not receive any youth services in the community.
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)
- Youths who have limited comprehension due to epilepsy or mental retardation.
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 active control group
This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community.
|
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No Intervention: non-hub user community control group
This group does not receive any youth services in the community.
|
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 1 year
|
Distress item from Kessler-6 (K-6), scores range from 0-24, higher scores indicate higher distress level
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Baseline, 3-month, 6-month, and 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive and anxiety
Time Frame: Baseline, 3-month, 6-month, and 1 year
|
Depression and Anxiety subscales in Depression Anxiety Stress Scales (DASS), scores range from 0-42, higher scores indicate higher symptom level
|
Baseline, 3-month, 6-month, and 1 year
|
Change in functioning
Time Frame: Baseline, 3-month, 6-month, and 1 year
|
Productivity loss (1-item in K6) and Social and Occupational Functioning Assessment Scale (SOFAS), scores range from 0-100, higher scores indicate better functioning
|
Baseline, 3-month, 6-month, and 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Yu Hai Chen, FHKAM(Psychiatry), The University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
November 1, 2019
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
March 3, 2021
First Submitted That Met QC Criteria
April 8, 2021
First Posted (Actual)
April 12, 2021
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 19-680
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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