The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub
Primary Purpose
Mental Stress
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
LevelMind@JC Mental Wellness Youth Hubs
Sponsored by
About this trial
This is an interventional treatment trial for Mental Stress focused on measuring youth mental health
Eligibility Criteria
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.
Sites / Locations
- Department of Psychiatry, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Hub user group
non-hub user active control group
non-hub user community control group
Arm Description
This group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being.
This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community.
This group does not receive any youth services in the community.
Outcomes
Primary Outcome Measures
Change in psychological distress
Distress item from Kessler-6 (K-6), scores range from 0-24, higher scores indicate higher distress level
Secondary Outcome Measures
Change in depressive and anxiety
Depression and Anxiety subscales in Depression Anxiety Stress Scales (DASS), scores range from 0-42, higher scores indicate higher symptom level
Change in functioning
Productivity loss (1-item in K6) and Social and Occupational Functioning Assessment Scale (SOFAS), scores range from 0-100, higher scores indicate better functioning
Full Information
NCT ID
NCT04840303
First Posted
March 3, 2021
Last Updated
June 27, 2023
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Hong Kong, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St James' Settlement
1. Study Identification
Unique Protocol Identification Number
NCT04840303
Brief Title
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub
Official Title
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hubs
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Hong Kong, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St James' Settlement
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress
Keywords
youth mental health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hub user group
Arm Type
Experimental
Arm Description
This group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being.
Arm Title
non-hub user active control group
Arm Type
No Intervention
Arm Description
This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community.
Arm Title
non-hub user community control group
Arm Type
No Intervention
Arm Description
This group does not receive any youth services in the community.
Intervention Type
Behavioral
Intervention Name(s)
LevelMind@JC Mental Wellness Youth Hubs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in psychological distress
Description
Distress item from Kessler-6 (K-6), scores range from 0-24, higher scores indicate higher distress level
Time Frame
Baseline, 3-month, 6-month, and 1 year
Secondary Outcome Measure Information:
Title
Change in depressive and anxiety
Description
Depression and Anxiety subscales in Depression Anxiety Stress Scales (DASS), scores range from 0-42, higher scores indicate higher symptom level
Time Frame
Baseline, 3-month, 6-month, and 1 year
Title
Change in functioning
Description
Productivity loss (1-item in K6) and Social and Occupational Functioning Assessment Scale (SOFAS), scores range from 0-100, higher scores indicate better functioning
Time Frame
Baseline, 3-month, 6-month, and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christy Lai Ming Hui, PhD
Phone
39179579
Email
christy@lmhui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Nam Suen, PhD
Phone
39179579
Email
suenyn@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Yu Hai Chen, FHKAM(Psychiatry)
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Lai Ming Hui, PhD
Email
christy@lmhui.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34894378
Citation
Hui CL, Suen YN, Lam BY, Wong SM, Wong CS, Lui SS, Chan KT, Wong MT, Chan SK, Lee EH, Chang WC, Wong GH, Chen EY. LevelMind@JC: Development and evaluation of a community early intervention program for young people in Hong Kong. Early Interv Psychiatry. 2022 Aug;16(8):920-925. doi: 10.1111/eip.13261. Epub 2021 Dec 11.
Results Reference
derived
Learn more about this trial
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub
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