NCT06868303

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
May 2025Apr 2028

First Submitted

Initial submission to the registry

March 7, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

March 7, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

Youth Mental Health

Outcome Measures

Primary Outcomes (3)

  • Change in Psychological Distress

    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

    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

    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 Outcomes (8)

  • Change in Depressive, Anxiety, and Stress Levels

    Baseline, 3-month, 6-month, and 12-month

  • Change in Social and Occupational Functioning

    Baseline, 3-month, 6-month, and 12-month

  • Change in Sleep Quality

    Baseline, 3-month, 6-month, and 12-month

  • Change in Physical Exercise

    Baseline, 3-month, 6-month, and 12-month

  • Change in Self-Esteem Level

    Baseline, 3-month, 6-month, and 12-month

  • +3 more secondary outcomes

Study Arms (6)

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.

Behavioral: LevelMind@JC Mental Wellness Youth Hubs

Non-hub User Community Control Group

NO INTERVENTION

This group does not receive any youth services in the community.

eClinic User Group

ACTIVE COMPARATOR

This group receives the eClinic service provided by New Life Psychiatric Rehabilitation Association.

Behavioral: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service

ICCMW group

ACTIVE COMPARATOR

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

GP group

ACTIVE COMPARATOR

This group receives services provided by general practitioners.

Other: General Practitioner

Hub Casework grpup

ACTIVE COMPARATOR

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 serviceBehavioral: Integrated Community Centres for Mental WellnessOther: General PractitionerBehavioral: Hub Casework

Interventions

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.

Hub User Group

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.

Hub Casework grpupeClinic User Group

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.

Hub Casework grpupICCMW group

Services provided by genersl practitioner

GP groupHub Casework grpup
Hub CaseworkBEHAVIORAL

Services provided during hub casework sessions

Hub Casework grpup

Eligibility Criteria

Age12 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Interventions

General Practitioners

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Christy Lai Ming Hui, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Lai Ming Hui, PhD

CONTACT

Yi Nam Suen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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. For the substudy examining the impact of the service model, a total of 252 participants will be recruited, with 63 individuals selected from each of the following groups: those receiving services through NLPRA eClinic, accessing care via the Integrated Community Centre for Mental Wellness (ICCMW) step-up program, managed by general practitioners, and isupported by hub casework services. For the substudy evaluating the impact pf Tier 1 activities, young people experiencing Tier 1 distress levels (determined by K6 \< 11), who have participated only in Tier 1 activities, will be recruited.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 10, 2025

Study Start

May 6, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations