Clinical trial NCT04840303: 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
Overall status: UNKNOWN
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 Hong Kong, Hong Kong
name: Hong Kong Federation of Youth's Group (HKFYG)
name: Hong Kong Playground Association
name: Hong Kong Children and Youth Services
name: St. James' Settlement
First posted: 2021-04-12
Enrollment: 1800
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in psychological distress
timeFrame: Baseline, 3-month, 6-month, and 1 year
Secondary outcomes:
measure: Change in depressive and anxiety
timeFrame: Baseline, 3-month, 6-month, and 1 year
measure: Change in functioning
timeFrame: Baseline, 3-month, 6-month, and 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychiatry, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Eric Yu Hai Chen, FHKAM(Psychiatry)
role: PRINCIPAL_INVESTIGATOR
References:
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.