- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361462
Joyful Adventure Day for Adolescents
Community-based Mental Wellness Project for Adolescents and Adults: Joyful Adventure Day - A Pilot Project
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cluster randomized controlled trial design will be adopted. The Project will organize two joyful adventure days in secondary schools in the form of physical activities and competitions with the following activities:
- Fitness assessment (enjoyment) and in-door games, which will be designed, supervised and supported by experienced social workers;
- Short interactive talk on SME, positive thinking and understanding of adolescent mental health problem (in particular the anxiety disorders) and mental well-being;
- Issue achievement / improvement stickers to students, and attractive prizes to the 10 fittest students by chairperson / members of Parent-Teacher Association (sharing);
- Provide physical activity diary after 1st session of adventure day, and invite family members / peers to join the competition at the 2nd session.
The major subjects of Joyful Adventure Day Pilot Project RCT study are 200-300 students. 3 schools will be included in the evaluation. The classes in the same school will either be assigned into intervention group or waitlist control group (the intervention won't be provided during evaluation period and will be provided after the evaluation period.).
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 fitness enjoyment, physical activity frequency, 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.
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 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)
- 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
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 group
Two joyful adventure days in the form of physical activities and competitions with adventure games and short interactive talk on SME.
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Participants will participate in two joyful adventure days with adventure games and a short talk on SME (Sharing, Mind, Enjoyment) focusing on positive thinking and understanding of adolescent mental health problem (in particular the anxiety disorders) and mental well-being; provide physical activity diary, such as "Zero-time Exercise" after 1st session of adventure day, and invite family members / peers to join the competition at the 2nd session.
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No Intervention: Waitlist control group
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 |
---|---|---|
Changes in the concept of Sharing, Mind and Enjoyment (SME) for adolescents and their family members.
Time Frame: T1: before the 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 behaviors from baseline to three-month after baseline.
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T1: before the 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the knowledge and understanding about mental health for adolescents and their family members.
Time Frame: T1: before the 1st Joyful Adventure Day (baseline); T2: immediately after the 1st Joyful Adventure Day ( post intervention ); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 4-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 1st Joyful Adventure Day (baseline); T2: immediately after the 1st Joyful Adventure Day ( post intervention ); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 4-month after baseline
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Changes in personal happiness from baseline to three-month after baseline
Time Frame: T1: before the 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
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Satisfaction toward Joyful Adventure Day Project
Time Frame: T2: immediately after the 1st Joyful Adventure Day ( post intervention ); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
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Satisfaction towards the adventure games, short interactive talk on SME and physical activity diary will be assessed by programme evaluation measure
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T2: immediately after the 1st Joyful Adventure Day ( post intervention ); T3: after the 2nd Joyful Adventure Day (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 Joyful Adventure Day 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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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel, Sai Yin Ho, Dr., Associate Professor
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
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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