Mental Health Wellness 1NCT03361462
Joyful Adventure Day for Adolescents
A study testing Joyful Adventure Day in people with Mental Health Wellness 1, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Joyful Adventure Day - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting Sharing, Mind and Enjoyment (SME) 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?
- Joyful Adventure Day
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Dec 2017to 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 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)
Show all 16Show fewer
- 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
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
About this study
Official title: Community-based Mental Wellness Project for Adolescents and Adults: Joyful Adventure Day - A Pilot Project
Joyful Adventure Day - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting Sharing, Mind and Enjoyment (SME) 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). Joyful Adventure Day - A Pilot Project aims to promote the SME related behaviors of adolescents through intervention of physical activities, and to promote their happiness, well-being and mental health knowledge.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Joyful Adventure Day
- Keywords
- Sharing, Mind, Enjoyment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Joyful Adventure DayBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Two joyful adventure days in the form of physical activities and competitions with adventure games and short interactive talk on SME. Receives: Behavioral: Joyful Adventure Day |
| Waitlist control group | No intervention | The 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.
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 behaviors from baseline to three-month after baseline.
Measured: T1: before the 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
Secondary outcomes (7)
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 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
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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (1-month after baseline); T4: 3-month after baseline
Satisfaction toward Joyful Adventure Day Project
Satisfaction towards the adventure games, short interactive talk on SME and physical activity diary will be assessed by programme evaluation measure
Measured: 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
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 Joyful Adventure Day 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
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.
- First posted4 Dec 2017
- Study start11 Dec 2017
- Primary completion30 Jun 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Boys' and Girls' Clubs Association of Hong Kong
- Responsible party
- Principal investigator, Dr. Daniel Sai-Yin Ho, The University of Hong Kong
- Investigators
- Daniel, Sai Yin Ho, Dr., Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361462
- Sponsor's protocol ID
- SPH-MHP-BGCA01
- Status last verified
- Oct 2021
- First submitted
- 27 Nov 2017
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Mental Wellness Project for Adolescents and Adults: Joyful Adventure Day - A Pilot Project
- ClinicalTrials.gov ID
- NCT03361462
- Acronym / sponsor ID
- SPH-MHP-BGCA01
- Conditions
- Mental Health Wellness 1
- Keywords
- Sharing, Mind, Enjoyment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Boys' and Girls' Clubs Association of Hong Kong
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Joyful Adventure Day - A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting Sharing, Mind and Enjoyment (SME) 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). Joyful Adventure Day - A Pilot Project aims to promote the SME related behaviors of adolescents through intervention of physical activities, and to promote their happiness, well-being and mental health knowledge.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Joyful Adventure DayTwo joyful adventure days in the form of physical activities and competitions with adventure games and short interactive talk on SME. |
| Waitlist control group | No intervention | –The intervention won't be provided during evaluation period and will be provided after the evaluation period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Students (major subjects): (Intervention group and waitlist control group)
- Parents: (Intervention group)
- School principals/teachers/community partners: (Intervention group)
Key exclusion criteria (1 listed)
- Students who cannot read Chinese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Joyful Adventure DayParticipants 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. | Behavioural | Intervention group |
Primary outcome
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
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.
7 secondary outcomes
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
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
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
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
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
The social impact of the community-based engagement project
Time frame: T4: 3-month after baseline
The process of community based intervention programme
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel, Sai Yin Ho, Dr. principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Joyful Adventure Day 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 16 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 20 Oct 2021. 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 1st Joyful Adventure Day (baseline); T3: after the 2nd Joyful Adventure Day (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?
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 20 Oct 2021.