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Mental Health Wellness 1NCT03368014

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

A study testing Lyrics-writing and singing show in people with Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1
What is being tested?
Lyrics-writing and singing show
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,784 participants
Where
1 siteHong Kong
Study dates
11 Sep 2017to 28 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • Students who cannot read Chinese

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Public Health, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Community-based Mental Wellness Project for Adolescents and Adults: "Fun．Feel．Share" Lyrics-writing and Singing Show - A Pilot Project

"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.

Read the 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.

Being tested
Lyrics-writing and singing show
Keywords
Sharing, Mind, Enjoyment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lyrics-writing and singing showBehavioural

    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.

Study groups in NCT03368014
Study groupRoleWhat they receive
Lyrics-writing and singing showExperimentalThe 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.
Receives: Behavioral: Lyrics-writing and singing show
Waitlist controlNo interventionThe workshops will not be provided to the control schools during the evaluation period and will be provided after the evaluation period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the concept of Sharing, Mind and Enjoyment (SME) for adolescents and their family members.

    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.

    Measured: 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)

Secondary outcomes (7)

  1. Changes in the knowledge and understanding about mental health for adolescents and their family members.

    The outcome-based questionnaire will be used to evaluate participants' knowledge and understanding about anxiety disorder from baseline to four-month after baseline.

    Measured: 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)

  2. Changes in personal happiness from baseline to four-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.

    Measured: 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)

  3. Changes in mental well-being from baseline to four-month after baseline.

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

    Measured: 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)

  4. Changes in individual and family health from baseline to four-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

    Measured: 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)

  5. Satisfaction toward "Fun．Feel．Share" Lyrics-writing and Singing Show Project

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

    Measured: 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)

  6. The social impact of the community-based engagement project

    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)

    Measured: T4: after the singing show and award ceremony (4-month after baseline)

  7. The process of community based intervention programme

    The process evaluation on-site observation questionnaire will be used to assess the process of the community-based intervention programs.

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2017
  2. Study start11 Sep 2017
  3. Primary completion30 Jun 2018
  4. Study completion28 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,784 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03368014
Sponsor's protocol ID
SPH-MHP-BGCA02
Status last verified
Oct 2021
First submitted
4 Sep 2017
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lyrics-writing and singing show in people with Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03368014.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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