- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368014
"Fun.Feel.Share" Lyrics-writing and Singing Show
Community-based Mental Wellness Project for Adolescents and Adults: "Fun.Feel.Share" Lyrics-writing and Singing Show - A Pilot Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cluster randomized controlled trial design will be adopted. The major subjects are 720-900 students. Four secondary schools in Hong Kong will be included in the evaluation. Schools will either be assigned into lyrics-writing and singing show intervention group or wait-list control group (the intervention won't be provided during the evaluation period and will be provided after the evaluation period).
The intervention mainly included 1) Lyrics-writing and Singing Competition with student and family entries: [a] lyrics-writing workshop and a short talk on SME focusing on praising family members and knowledge of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; [b] use SME as theme for lyrics-writing and submit records of SME during lyrics-writing and singing; and [d] all entries are submitted in the form of audios. 2) SME Lyrics-writing and Singing Show and Award Ceremony (sharing): live performance by awarded entries and prize presentation ceremony.
There will then be 4 assessments (pre-intervention, immediate post intervention, one month and three months after baseline) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete questionnaires to measure the changes in SME related behaviors, happiness, well-being and knowledge and attitude towards mental health. The satisfaction towards the intervention, as well as the level of participation and ratings for the intervention will be evaluated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- School of Public Health, The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Students (major subjects): (Intervention group and waitlist control group)
- Chinese speaking
- Intact verbal and hearing abilities for interpersonal communication
- Reading and writing abilities for questionnaire completion
- Secondary school students
Parents: (Intervention group)
- Chinese speaking
- Intact verbal and hearing abilities for interpersonal communication
- Reading and writing abilities for questionnaire completion
- With at least one secondary school child
School principals/teachers/community partners: (Intervention group)
- Principals/teachers of intervention school and/or staffs of The Boys' and Girls' Clubs Association in partnership with HKU research team who organize plan or implement the project
- Adults aged 18 or above
- Chinese speaking
- Intact verbal and hearing abilities for interpersonal communication
- Reading and writing abilities for questionnaire/individual in-depth interviews completion
Exclusion Criteria:
- Students who cannot read Chinese
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Lyrics-writing and singing show
The one-hour lyrics-writing and singing workshop was conducted first at the beginning of the programme for the intervention group, followed by two small workshops teaching lyrics-writing skills and the lyrics-writing competition after the workshop.
A lyrics writing and singing show and an award ceremony will be held at the end.
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Participants will participate in a Lyrics-Writing and Singing Competition.
They will first attend a lyrics-writing workshop and a short talk on SME (Sharing, Mind, Enjoyment) focusing on praising family members and knowledge of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; submit SME (Sharing, Mind, Enjoyment) worksheet, such as "Express Your Love to Family Member" after the workshops; participate in the SME (Sharing, Mind, Enjoyment) Lyrics-writing and Singing Show and Award Ceremony (sharing) with a live performance by awarded entries and prize presentation ceremony.
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No Intervention: Waitlist control
The workshops will not be provided to the control schools during the evaluation period and will be provided after the evaluation period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the concept of Sharing, Mind and Enjoyment (SME) for adolescents and their family members.
Time Frame: T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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The outcome-based questionnaire will be used to evaluate participants' frequency of performing the suggested Sharing, Mind and Enjoyment (SME) related behaviors from baseline to four-month after baseline.
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T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the knowledge and understanding about mental health for adolescents and their family members.
Time Frame: T1: before the lyrics-writing workshop (baseline); T2: immediately after the workshop ( post intervention ); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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The outcome-based questionnaire will be used to evaluate participants' knowledge and understanding about anxiety disorder from baseline to four-month after baseline.
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T1: before the lyrics-writing workshop (baseline); T2: immediately after the workshop ( post intervention ); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Changes in personal happiness from baseline to four-month after baseline
Time Frame: T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Personal Personal happiness will be assessed by Subjective Happiness Scale (SHS).
SHS was rated on 7-point scale with 1 indicating not happiness at all and 7 indicating extreme happiness.
To score the scale, the 4th item will be coded reversely and mean of the 4 items will be computed.
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T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Changes in mental well-being from baseline to four-month after baseline.
Time Frame: T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Mental well-being will be assessed by validated Chinese version of 7-item Warwick Edinburgh Well-being Scale
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T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Changes in individual and family health from baseline to four-month after baseline
Time Frame: T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Self-perceived health, happiness and harmony at the individual and family level will be assessed by a 0-10 score at 3 time points
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T1: before the lyrics-writing workshop (baseline); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Satisfaction toward "Fun.Feel.Share" Lyrics-writing and Singing Show Project
Time Frame: T2: immediately after the workshop ( post intervention ); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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Satisfaction towards the workshop, lyrics-writing competition, singing show and award ceremony will be assessed by programme evaluation measure
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T2: immediately after the workshop ( post intervention ); T3: after the lyrics-writing competition (2-month after baseline); T4: after the singing show and award ceremony (4-month after baseline)
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The social impact of the community-based engagement project
Time Frame: T4: after the singing show and award ceremony (4-month after baseline)
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The social impact of the community-based engagement project will be The satisfaction, ratings and opinions on "Fun.Feel.Share" Lyrics-writing and Singing Show programme of school principal/teacher/community partner in the intervention group will be assessed qualitatively (individual in-depth interviews)
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T4: after the singing show and award ceremony (4-month after baseline)
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The process of community based intervention programme
Time Frame: up to 4 months
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The process evaluation on-site observation questionnaire will be used to assess the process of the community-based intervention programs.
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up to 4 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel, Sai Yin Ho, Dr., Associate Professor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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