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Mental Health Wellness 1NCT03361475

SME(Sharing, Mind & Enjoyment) App for Adolescents

A study testing SME App 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

SME (Sharing, Mind, Enjoyment) App, A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental wellbeing. 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?
SME App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
1 siteHong Kong
Study dates
11 Jan 2018to 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 control group):
  • Chinese speaking
  • Intact verbal and hearing abilities for interpersonal communication
  • Reading and writing abilities for questionnaire completion
  • Can use the smartphone
  • Form 1 to 4 students
Show all 18Show fewer
  • Parents (intervention group):
  • Chinese speaking
  • Intact verbal and hearing abilities for interpersonal communication
  • Reading and writing abilities for questionnaire completion
  • Can use the smartphone
  • With at least one child between form 1 to 4
  • School principals/teachers/community partners (intervention group):
  • Principals/teachers of intervention school or staffs of Tung Wah Group of Hospitals 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 SME (Sharing, Mind & Enjoyment) App - A Pilot Project

SME (Sharing, Mind, Enjoyment) App, A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental wellbeing. 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). This project primarily aims to promote the SME related behaviors of adolescents through the App. The evaluation will be conducted during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention, will be evaluated.

Read the detailed description

A cluster randomized controlled trial design was adopted. The major subjects of SME (Sharing, Mind, Enjoyment) App Pilot Project RCT Study are 300-500 middle school students. Two schools will be recruited and randomized to each group. Schools will either be assigned to app intervention group or waitlist control group. The students in the intervention group will use the App for one month. Daily and Weekly tasks related to SME will be assigned through the App, and information related to mental health will be provided. The waitlist control group will be able to use the App after we finish all the assessments.

There will then be 4 assessments (pre-intervention, immediate post-intervention, one month and three months after) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete a questionnaire to measure the changes in SME (sharing, mind and enjoyment) related behaviors, changes of knowledge and attitude towards the anxiety disorder, changes of happiness and well-being.

Being tested
SME App
Keywords
Sharing, Mind, Enjoyment

What participants receive

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

  • SME AppBehavioural

    The features in the App could be used in the future by linking with some platforms / existing services so that more SME messages can be sent to the students for sharing. One school workshop will be held to promote SME and introduce the function of SME App for students to download and use immediately to connect family members.

    SME App promotes SME via:

    • Express gratitude to family members (sharing)
    • Deliver positive messages regularly (mind)
    • Record physical and other joyful activities (enjoyment)
    • Increase knowledge and understanding of adolescent mental health problem (in particular the anxiety disorders)
Study groups in NCT03361475
Study groupRoleWhat they receive
Intervention schoolExperimentalOne school workshop and a small talk were conducted first at the beginning of the programme, which was to promote SME and introduce the function of SME App for students, followed by downloading and using immediately to connect family members, then let them continue to use for one month with system reminder.
Receives: Behavioral: SME App
Waitlist control schoolsNo interventionThe intervention won't be provided during 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 behaviours from baseline to three-month after baseline.

    Measured: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-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 three-month after baseline.

    Measured: T1: before the SME App workshop (baseline); T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-month after baseline

  2. Changes in personal happiness from baseline to three-month after baseline

    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 SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline

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

    Mental well-being will be assessed by validated Chinese version of 7-item Warwick Edinburgh Well-being Scale. Each item ranges from 1 to 5 and the scale will be scored by first summing the score for each of the 7 items and then transforming the total score for each person according to a conversion table.

    Measured: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline

  4. Changes in individual and family health from baseline to three-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 SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline

  5. Satisfaction toward SME App Project

    Satisfaction towards the workshop, short interactive talk on SME and SME app will be assessed by programme evaluation measure

    Measured: T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-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 SME App programme of school principal/teacher/community partner in the intervention group will be assessed qualitatively (individual in-depth interviews)

    Measured: T4: 3-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 3 months

Timeline

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

  1. First posted4 Dec 2017
  2. Study start11 Jan 2018
  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
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361475
Sponsor's protocol ID
SPH-MHP-TWGH01
Status last verified
Mar 2019
First submitted
28 Nov 2017
Last updated
29 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun Y, Wang MP, Ho SY, Chan CS, Man PKW, Kwok T, Wan ANT, Lam TH. A Smartphone App for Promoting Mental Well-being and Awareness of Anxious Symptoms in Adolescents: A Pilot Cluster Randomized Controlled Trial. Games Health J. 2022 Oct 3. doi: 10.1089/g4h.2021.0215. Online ahead of print.

    PubMed 36194074

Questions about this trial

What is this clinical trial studying?

A study testing SME App 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 18 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 29 Mar 2019. 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 SME App workshop (baseline); T3: 1-month after baseline; T4: 3-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 NCT03361475, which also lists 1 linked publication.

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 29 Mar 2019.

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