The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hub

Mental Stress Clinical Trial

Official title:

The Effectiveness and Cost-effectiveness of Mental Wellness Youth Hubs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04840303
• Other study ID #: UW 19-680
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: June 2023
• Source: The University of Hong Kong
• Contact: Christy Lai Ming Hui, PhD
• Phone: 39179579
• Email: christy[@]lmhui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Stress
• Stress, Psychological

Intervention

Behavioral:
• LevelMind@JC Mental Wellness Youth Hubs
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.

Locations

Country	Name	City	State
Hong Kong	Department of Psychiatry, The University of Hong Kong	Hong Kong

Sponsors (8)

Lead Sponsor	Collaborator
The University of Hong Kong	Caritas Hong Kong, Hong Kong, Hong Kong Children and Youth Services, Hong Kong Federation of Youth's Group, Hong Kong Jockey Club Charities Trust, Hong Kong Playground Association, St James' Settlement, The Boys' and Girls' Clubs Association of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in psychological distress	Distress item from Kessler-6 (K-6), scores range from 0-24, higher scores indicate higher distress level	Baseline, 3-month, 6-month, and 1 year
Secondary	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	Baseline, 3-month, 6-month, and 1 year
Secondary	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	Baseline, 3-month, 6-month, and 1 year