- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361475
SME(Sharing, Mind & Enjoyment) App for Adolescents
Community-based Mental Wellness Project for Adolescents and Adults SME (Sharing, Mind & Enjoyment) App - A Pilot Project
Study Overview
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.
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 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
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
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: Intervention school
One 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.
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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:
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No Intervention: Waitlist control schools
The intervention won't be provided during 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 |
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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
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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 behaviours from baseline to three-month after baseline.
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T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The process of community based intervention programme
Time Frame: up to 3 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 3 months
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Changes in the knowledge and understanding about mental health for adolescents and their family members.
Time Frame: 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
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The outcome-based questionnaire will be used to evaluate participants' knowledge and understanding about anxiety disorder from baseline to three-month after baseline.
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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
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Changes in personal happiness from baseline to three-month after baseline
Time Frame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
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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 SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
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Changes in mental well-being from baseline to three-month after baseline
Time Frame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-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.
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.
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T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
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Changes in individual and family health from baseline to three-month after baseline
Time Frame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-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 SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
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Satisfaction toward SME App Project
Time Frame: T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-month after baseline
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Satisfaction towards the workshop, short interactive talk on SME and SME app will be assessed by programme evaluation measure
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T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-month after baseline
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The social impact of the community-based engagement project
Time Frame: T4: 3-month after baseline
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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)
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T4: 3-month after baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yuying Sun, Dr., Post-doctoral Fellow
Publications and helpful links
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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