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SME(Sharing, Mind & Enjoyment) App for Adolescents

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ClinicalTrials.gov Identifier: NCT03361475
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
Tung Wah Group of Hospitals
Information provided by (Responsible Party):
Dr Sun Yuying, The University of Hong Kong

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: SME App Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 408 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 SME (Sharing, Mind & Enjoyment) App - A Pilot Project
Actual Study Start Date : January 11, 2018
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
U.S. FDA Resources

Arm Intervention/treatment
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.
Behavioral: SME App

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)
No Intervention: Waitlist control schools
The intervention won't be provided during evaluation period and will be provided after the evaluation period



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


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

  2. 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 ]
    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 three-month after baseline [ Time Frame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-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.

  4. 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 ]
    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 SME App Project [ Time Frame: T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-month after baseline ]
    Satisfaction towards the workshop, short interactive talk on SME and SME app will be assessed by programme evaluation measure

  6. The social impact of the community-based engagement project [ Time Frame: T4: 3-month after baseline ]
    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)

  7. The process of community based intervention programme [ Time Frame: up to 3 months ]
    The process evaluation on-site observation questionnaire will be used to assess the process of the community-based intervention programs.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Students (major subjects) (intervention group and control group):

    1. Chinese speaking
    2. Intact verbal and hearing abilities for interpersonal communication
    3. Reading and writing abilities for questionnaire completion
    4. Can use the smartphone
    5. Form 1 to 4 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. Can use the smartphone
    5. With at least one child between form 1 to 4
  • School principals/teachers/community partners (intervention group):

    1. 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
    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

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): NCT03361475


Locations
Hong Kong
School of Public Health, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Tung Wah Group of Hospitals
Investigators
Principal Investigator: Yuying Sun, Dr. Post-doctoral Fellow

Responsible Party: Dr Sun Yuying, Principle investigator, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03361475     History of Changes
Other Study ID Numbers: SPH-MHP-TWGH01
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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

Keywords provided by Dr Sun Yuying, The University of Hong Kong:
Sharing
Mind
Enjoyment