Clinical trial NCT03361475: SME(Sharing, Mind & Enjoyment) App for Adolescents
Official title: Community-based Mental Wellness Project for Adolescents and Adults SME (Sharing, Mind & Enjoyment) App - A Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Sharing
Mind
Enjoyment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tung Wah Group of Hospitals
First posted: 2017-12-04
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in the concept of Sharing, Mind and Enjoyment (SME) for adolescents and their family members.
timeFrame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
Secondary outcomes:
measure: Changes in the knowledge and understanding about mental health for adolescents and their family members.
timeFrame: 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
measure: Changes in personal happiness from baseline to three-month after baseline
timeFrame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
measure: Changes in mental well-being from baseline to three-month after baseline
timeFrame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
measure: Changes in individual and family health from baseline to three-month after baseline
timeFrame: T1: before the SME App workshop (baseline); T3: 1-month after baseline; T4: 3-month after baseline
measure: Satisfaction toward SME App Project
timeFrame: T2: immediately after the SME App workshop ( post intervention ); T3: 1-month after baseline; T4: 3-month after baseline
measure: The social impact of the community-based engagement project
timeFrame: T4: 3-month after baseline
measure: The process of community based intervention programme
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Public Health, The University of Hong Kong
Study officials:
affiliation: Post-doctoral Fellow
name: Yuying Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.