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"Fun．Feel．Share＂ Lyrics-writing and Singing Show

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ClinicalTrials.gov Identifier: NCT03368014
Recruitment Status : Active, not recruiting
First Posted : December 11, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
The Boys' & Girls' Clubs Association of Hong Kong
Information provided by (Responsible Party):
Dr. Daniel Sai-Yin Ho, The University of Hong Kong

Study Description
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Brief Summary:
"Fun．Feel．Share＂ Lyrics-writing and Singing Show - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting Sharing, Mind and Enjoyment (SME) and enhancing mental well-being. The Mental Wellness Project is financially supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public Health, University of Hong Kong (HKU). "Fun．Feel．Share" Lyrics-writing and Singing Show - A Pilot Project aims to promote the SME related behaviors of adolescents through intervention of physical activities, and to promote their happiness, well-being and mental health knowledge.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Lyrics-writing and singing show Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Community-based Mental Wellness Project for Adolescents and Adults: "Fun．Feel．Share＂ Lyrics-writing and Singing Show - A Pilot Project
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Lyrics-writing and singing show
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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) ]
    The outcome-based questionnaire will be used to evaluate participants' knowledge and understanding about anxiety disorder from baseline to four-month after baseline.

  2. 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) ]
    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.

  3. 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) ]
    Mental well-being will be assessed by validated Chinese version of 7-item Warwick Edinburgh Well-being Scale

  4. 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) ]
    Self-perceived health, happiness and harmony at the individual and family level will be assessed by a 0-10 score at 3 time points

  5. 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) ]
    Satisfaction towards the workshop, lyrics-writing competition, singing show and award ceremony will be assessed by programme evaluation measure

  6. The social impact of the community-based engagement project [ Time Frame: T4: after the singing show and award ceremony (4-month after baseline) ]
    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)

  7. The process of community based intervention programme [ Time Frame: up to 4 months ]
    The process evaluation on-site observation questionnaire will be used to assess the process of the community-based intervention programs.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Students (major subjects): (Intervention group and waitlist control group)

    1. Chinese speaking
    2. Intact verbal and hearing abilities for interpersonal communication
    3. Reading and writing abilities for questionnaire completion
    4. Secondary school students

  • Parents: (Intervention group)

    1. Chinese speaking
    2. Intact verbal and hearing abilities for interpersonal communication
    3. Reading and writing abilities for questionnaire completion
    4. With at least one secondary school child

  • School principals/teachers/community partners: (Intervention group)

    1. 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
    2. Adults aged 18 or above
    3. Chinese speaking
    4. Intact verbal and hearing abilities for interpersonal communication
    5. Reading and writing abilities for questionnaire/individual in-depth interviews completion

Exclusion Criteria:

  • Students who cannot read Chinese
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368014


Locations
Hong Kong
School of Public Health, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
The Boys' & Girls' Clubs Association of Hong Kong
Investigators
Principal Investigator: Daniel, Sai Yin Ho, Dr. Associate Professor
  Study Documents (Full-Text)

Documents provided by Dr. Daniel Sai-Yin Ho, The University of Hong Kong:
Study Protocol and Statistical Analysis Plan  [PDF] June 1, 2017

More Information
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Responsible Party: Dr. Daniel Sai-Yin Ho, Associate professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03368014     History of Changes
Other Study ID Numbers: SPH-MHP-BGCA02
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Daniel Sai-Yin Ho, The University of Hong Kong:
Sharing
Mind
Enjoyment