Clinical trial NCT03332810: Healthy Community Pilot Project RCT Study
Official title: Community-based Mental Wellness Project for Adolescents and Adults: Healthy Community Pilot Project RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Well-being
Happiness
Keywords: Mental health
Mental well-being
Community-based engagement
Positive psychology
Public health approach
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Council of Social Service
First posted: 2017-11-06
Enrollment: 342
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aims: To enhance mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community.

Targets: Adults aged 18-59 and their family members in Hong Kong.

Methods: Healthy Community Pilot Project will adopt the public health and family-focused approach, under the brand name of "Joyful@HK Campaign". Evidence-based and Evidence Generating approach with vigorous study design, both qualitative (e.g. focus groups) and quantitative (e.g. randomised controlled trial), will be used to evaluate the overall programme effectiveness including follow-up of at least one month ("best science"). To ensure the practicability and sustainability of the community-based engagement project, we will engage community partners with strong track records of "best practice" to design, plan, and implement the intervention. This project will use innovative and integrated positive psychology and public health theories and methods to plan brief, simple, and cost-effective intervention.

Significance: By using "best science" in the design and evaluation of intervention programme, and the "best practice" of the partners' skills, experience and strong connection with service targets in the community, the intervention, if proven to be effective, for promoting sharing, mind and enjoyment and enhancing mental well-being can be further developed and widely disseminated to and adopted by the practitioners in the health and social service sectors for replication and improvement to benefit the whole population.

Detailed description: Healthy Community Pilot Project is one of the six Community-based Mental Wellness Project for Adolescents and Adults, which aims at enhancing mental well-being of adolescents, adults and their families by creating a positive, happy and joyful environment in the community. The project is funded by Health Care and Promotion Fund of Food and Health Bureau.

Healthy Community Pilot Project is organized by the Hong Kong Council of Social Service and led by the School of Public Health, The University of Hong Kong.The project will organize one train-the-trainer workshop to train the service providers from 8-10 NGO service units on the concept of sharing, mind and enjoyment (SME), ways of conducting SME family-based physical activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder). Two SME family-based physical activities will be held by the NGO service providers in collaboration with 3 District Healthy City Committees. Each NGO service unit may organize enjoyable SME family-based physical activities according to the needs of individual district and to promote positive psychology under the theme of Sharing, Mind and Enjoyment. One wisdom sharing session will be organized to members of District Healthy City Committees to promote best practice of community mental wellness project.

The major subjects of the Healthy Community Pilot Project RCT study are 150-200 families with 400 participants. 3 District Healthy City Committees will be selected as collaborators. 10-18 NGO service units will either be randomized into intervention service units and control service units. Cluster Randomized Control Trial will be used to evaluate the effectiveness of the intervention programme.

In the study, families will be invited to complete a series of questionnaires or invited to attend focus groups to measure the sharing, mind and enjoyment related behavioural changes, mental well-being and subjective changes. NGO workers who joined the train-the-trainer workshop will also be invited to complete questionnaires to measure their knowledge about mental health, skills of conducting SME family-based physical activities and their sharing, mind and enjoyment related behavioural change. They will be invited to focus group interview to assess their experience and feedback on this project while community partners will be invited to individual in-depth interviews to assess the outcomes of community engagement process.

HKU team will conduct evaluation during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention will also be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Families (Major subjects):

   * Adults aged 18-59 and their family members (Their family members could be children)
   * Chinese speaking
   * Able to complete study questionnaires/ focus groups
2. Service providers of NGO service units

   * Staff working in the participating NGO service units
   * Adults aged 18-59
   * Chinese speaking
   * Able to complete study questionnaires/ focus group
3. Community partners

   * Staff working in the collaborating NGO service units or District Healthy City Committees in partnership with HKU research team to organize or plan or implement the project
   * Chinese speaking
   * Able to complete study questionnaires/ individual in-depth interviews

Exclusion Criteria:

* Those who cannot read Chinese
* Those who suffered from severe mental disorders

Primary outcomes:
measure: Changes in participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviours
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
Secondary outcomes:
measure: Changes in personal happiness from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in mental well-being from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in family relationship from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in individual and family health from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in individual and family happiness from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in family harmony from baseline to three-month after baseline
timeFrame: T1: baseline; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Changes in knowledge and perception of mixed anxiety and depressive disorders
timeFrame: T1: baseline; T2: immediate post intervention; T3: one-month follow-up after baseline; T4: three-month follow up after baseline
measure: Satisfaction towards SME physical activity training & program
timeFrame: T2: immediate post intervention; T3: one-month follow-up after baseline
measure: The social impact of the community-based engagement project
timeFrame: Up to four months
measure: The process of community based intervention programme
timeFrame: Up to four months
measure: Outcomes of community engagement process
timeFrame: Up to four months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Council of Social Service
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Wang
role: PRINCIPAL_INVESTIGATOR
References: