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临床试验/NCT06868303
NCT06868303招募中不适用

A Quasi-controlled Study on the Effectiveness of Mental Wellness Youth Hubs in Hong Kong

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2025年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,300
试验地点
1
主要终点
Change in Psychological Distress

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: LevelMind@JC Mental Wellness Youth Hubs (Behavioral)

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.

干预措施: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service (Behavioral)

ICCMW group

Active Comparator

This group receives the eClinic service provided by Integrated Community Centre for Mental Wellness (ICCMW) step-up care.

干预措施: Integrated Community Centres for Mental Wellness (Behavioral)

GP group

Active Comparator

This group receives services provided by general practitioners.

干预措施: General Practitioner (Other)

Hub Casework grpup

Active Comparator

This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.

干预措施: New Life Psychiatric Rehabilitation Association electronic clinic for psychological service (Behavioral)

Hub Casework grpup

Active Comparator

This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.

干预措施: Integrated Community Centres for Mental Wellness (Behavioral)

Hub Casework grpup

Active Comparator

This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.

干预措施: General Practitioner (Other)

Hub Casework grpup

Active Comparator

This group receives services from hub casework support, as well as from NLPRA eClinic, ICCMW, and general practitioners.

干预措施: Hub Casework (Behavioral)

结局指标

主要结局

Change in Psychological Distress

时间窗: Baseline, 3-month, 6-month, and 12-month

The 6-item Kessler Psychological Distress Scale (scores range from 0 to 24 where a higher score indicates a worse outcome)

Change in Well-being

时间窗: Baseline, 3-month, 6-month, and 12-month

The World Health Organization-Five Well-Being Index (scores range from 0 to 25 where a higher score indicates a better outcome)

Change in Quality of Life

时间窗: Baseline, 3-month, 6-month, and 12-month

The 12-item Short-Form 12 Health Survey (scores range from 0 to 100 where a higher score indicates a better outcome)

次要结局

  • 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)
  • Change in Psychological Resilience(Baseline, 3-month, 6-month, and 12-month)
  • Change in Cognitive Function(Baseline, 3-month, 6-month, and 12-month)
  • Change in Health Economics(Baseline, 3-month, 6-month, and 12-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Christy Lai-ming Hui

Associate Professor

The University of Hong Kong

研究点 (1)

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