NCT04840303

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

March 3, 2021

Last Update Submit

June 27, 2023

Conditions

Keywords

youth mental health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in depressive and anxiety

    Baseline, 3-month, 6-month, and 1 year

  • Change in functioning

    Baseline, 3-month, 6-month, and 1 year

Study Arms (3)

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 active control group

NO INTERVENTION

This group does not receive the community-based mental wellness youth hub services but other generic youth services in the community.

non-hub user community control group

NO INTERVENTION

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

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

Eligibility Criteria

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

You may qualify if:

  • 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.

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)
  • Youths who have limited comprehension due to epilepsy or mental retardation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Eric Yu Hai Chen, FHKAM(Psychiatry)

    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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

April 12, 2021

Study Start

November 1, 2019

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations