Mental StressNCT04840303
The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub
A study testing LevelMind@JC Mental Wellness Youth Hubs in people with Mental Stress, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- LevelMind@JC Mental Wellness Youth Hubs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Psychiatry, The University of Hong Kong
Hong Kong
Christy Lai Ming Hui, PhD, christy@lmhui.com
About this study
Official title: 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.
- Conditions
- Mental Stress
- Being tested
- LevelMind@JC Mental Wellness Youth Hubs
- Keywords
- youth mental health
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevelMind@JC Mental Wellness Youth HubsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hub user group | Experimental | This group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being. Receives: Behavioral: LevelMind@JC Mental Wellness Youth Hubs |
| non-hub user active control group | No intervention | This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community. |
| non-hub user community control group | No intervention | This group does not receive any youth services in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological distress
Distress item from Kessler-6 (K-6), scores range from 0-24, higher scores indicate higher distress level
Measured: Baseline, 3-month, 6-month, and 1 year
Secondary outcomes (2)
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
Measured: Baseline, 3-month, 6-month, and 1 year
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
Measured: Baseline, 3-month, 6-month, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Nov 2019
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental StressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St. James' Settlement
- Responsible party
- Principal investigator, Professor Eric Y.H. Chen, The University of Hong Kong
- Investigators
- Eric Yu Hai Chen, FHKAM(Psychiatry), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840303
- Sponsor's protocol ID
- UW 19-680
- Status last verified
- Jun 2023
- First submitted
- 3 Mar 2021
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34894378
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hubs
- ClinicalTrials.gov ID
- NCT04840303
- Acronym / sponsor ID
- UW 19-680
- Conditions
- Mental Stress
- Keywords
- youth mental health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Jockey Club Charities Trust, The Boys' and Girls' Clubs Association of Hong Kong, Caritas Medical Centre, Hong Kong, Hong Kong Federation of Youth's Group, Hong Kong Playground Association, Hong Kong Children and Youth Services, St. James' Settlement
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hub user group | Experimental | Behavioral: LevelMind@JC Mental Wellness Youth HubsThis group receives community-based mental wellness youth hub services for young people to enhance personal strengths and overall mental well-being. |
| non-hub user active control group | No intervention | –This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community. |
| non-hub user community control group | No intervention | –This group does not receive any youth services in the community. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevelMind@JC Mental Wellness Youth HubsMental 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. | Behavioural | Hub user group |
Primary outcome
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
2 secondary outcomes
Change in depressive and anxiety
Time frame: Baseline, 3-month, 6-month, and 1 year
Change in functioning
Time frame: Baseline, 3-month, 6-month, and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 34894378Hui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Yu Hai Chen, FHKAM(Psychiatry) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LevelMind@JC Mental Wellness Youth Hubs in people with Mental Stress, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christy Lai Ming Hui, PhD (39179579, christy@lmhui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological distress (time frame: Baseline, 3-month, 6-month, and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.