Clinical trial NCT06868303: The Effectiveness of Mental Wellness Youth Hubs in Hong Kong
Official title: A Quasi-controlled Study on the Effectiveness of Mental Wellness Youth Hubs in Hong Kong
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Stress
Keywords: Youth Mental Health
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: The Boys' and Girls' Clubs Association of Hong Kong
name: Caritas Medical Centre, Hong Kong
name: Hong Kong Christian Service
name: Neighbourhood Advice-Action Council
name: St. James' Settlement
name: Tung Wah Group of Hospitals
name: Hong Kong Young Women's Christian Association
name: Yan Oi Tong
name: Chinese YMCA of Hong Kong
name: New Life Psychiatric Rehabilitation Association
name: The Salvation Army, Hong Kong and Macau Command
name: Hong Kong Playground Association (HKPA)
name: Hong Kong Sheng Kung Hui Welfare Council Limited
name: Hong Kong Children and Youth Services (HKCYS)
name: Hong Kong Federation of Youth's Group (HKFYG)
name: Chinese Young Men's Christian Association of Hong Kong
First posted: 2025-03-10
Enrollment: 1300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Psychological Distress
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Well-being
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Quality of Life
timeFrame: Baseline, 3-month, 6-month, and 12-month
Secondary outcomes:
measure: Change in Depressive, Anxiety, and Stress Levels
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Social and Occupational Functioning
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Sleep Quality
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Physical Exercise
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Self-Esteem Level
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Psychological Resilience
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Cognitive Function
timeFrame: Baseline, 3-month, 6-month, and 12-month
measure: Change in Health Economics
timeFrame: Baseline, 3-month, 6-month, and 12-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Community
Study officials:
affiliation: The University of Hong Kong
name: Christy Lai Ming Hui, PhD
role: PRINCIPAL_INVESTIGATOR
References: