HealthyNCT02517450
Effectiveness of an Adventure-based Training Programme
A study testing an adventure-based training programme in people with Healthy, run by The University of Hong Kong.
Trial summary
This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training… Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- an adventure-based training programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2011
- 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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Hong Kong Chinese primary pupils from forms 5 and 6 of two schools were invited to participate in the study.
Who cannot join
- those with a chronic illness or identified cognitive and learning problems were excluded.
About this study
Official title: Effectiveness of an Adventure-based Training Programme in Promoting the Psychological Well-being of Primary School Children
This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training programme and 64 to the attention placebo control group.
- Conditions
- Healthy
- Being tested
- an adventure-based training programme, a placebo control programme
- Keywords
- Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an adventure-based training programmeBehavioural
The programme consisted of five education sessions (around 75 minutes each) and a day's adventure-based training camp at the end of the academic year
a placebo control programmeOther
Subjects in the control group were invited to attend five 75-minute sessions of leisure activities, organised by a community centre, which included a cartoon film show, handicraft workshops, a health talk on the prevention of influenza and age-appropriate physical leisure activities, such as table tennis, badminton, chess and Chinese billiards. Additionally, they were invited to join a day visit to Hong Kong Ocean Park at the end of the academic year.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The subjects had to participate an adventure-based training programme. Receives: Behavioral: an adventure-based training programme |
| placebo control group | Placebo comparator | The subjects had to participate a placebo control programme Receives: Other: a placebo control programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Center for Epidemiologic Studies Depression Scale for Children at baseline
baseline depressive symptoms
Measured: baseline
change of The Center for Epidemiologic Studies Depression Scale for Children at 9 months from baseline
depressive symptoms after the last intervention session
Measured: 9 months
change of The Center for Epidemiologic Studies Depression Scale for Children at 12 months from baseline
depressive symptoms after 3 months from the last intervention session
Measured: 12 months
Secondary outcomes (9)
The Chinese version of the State Anxiety Scale for Children at baseline
baseline anxiety level
Measured: baseline
change of The Chinese version of the State Anxiety Scale for Children at 9 months from baseline
anxiety level after the last intervention session
Measured: 9 months
change of The Chinese version of the State Anxiety Scale for Children at 12 months from baseline
anxiety level after 3 months from the last intervention session
Measured: 12 months
The Rosenberg Self-esteem Scale at baseline
baseline self-esteem
Measured: baseline
change of The Rosenberg Self-esteem Scale at 9 month from baseline
self-esteem after the last intervention session
Measured: 9 months
change of The Rosenberg Self-esteem Scale at 12 month from baseline
self-esteem after 3 months from the last intervention session
Measured: 12 months
The Pediatric Quality of Life Inventory Generic at baseline
baseline quality of life
Measured: baseline
change of The Pediatric Quality of Life Inventory Generic at 9 months from baseline
quality of life after the last intervention session
Measured: 9 months
change of The Pediatric Quality of Life Inventory Generic at 12 months from baseline
quality of life after 3 months from the last intervention session
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William, Ho Cheung LI, PhD, Principal investigator, School of Nursing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517450
- Sponsor's protocol ID
- UW 12-237
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Adventure-based Training Programme in Promoting the Psychological Well-being of Primary School Children
- ClinicalTrials.gov ID
- NCT02517450
- Acronym / sponsor ID
- UW 12-237
- Conditions
- Healthy
- Keywords
- Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Aug 2015 (estimated)
- 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.
This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training programme and 64 to the attention placebo control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: an adventure-based training programmeThe subjects had to participate an adventure-based training programme. |
| placebo control group | Placebo comparator | Other: a placebo control programmeThe subjects had to participate a placebo control programme |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hong Kong Chinese primary pupils from forms 5 and 6 of two schools were invited to participate in the study.
Key exclusion criteria (1 listed)
- those with a chronic illness or identified cognitive and learning problems were excluded.
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 |
|---|---|---|
| an adventure-based training programmeThe programme consisted of five education sessions (around 75 minutes each) and a day's adventure-based training camp at the end of the academic year | Behavioural | experimental group |
| a placebo control programmeSubjects in the control group were invited to attend five 75-minute sessions of leisure activities, organised by a community centre, which included a cartoon film show, handicraft workshops, a health talk on the prevention of influenza and age-appropriate physical leisure activities, such as table tennis, badminton, chess and Chinese billiards. Additionally, they were invited to join a day visit to Hong Kong Ocean Park at the end of the academic year. | Other | placebo control group |
Primary outcome
The Center for Epidemiologic Studies Depression Scale for Children at baseline
Time frame: baseline
baseline depressive symptoms
change of The Center for Epidemiologic Studies Depression Scale for Children at 9 months from baseline
Time frame: 9 months
depressive symptoms after the last intervention session
change of The Center for Epidemiologic Studies Depression Scale for Children at 12 months from baseline
Time frame: 12 months
depressive symptoms after 3 months from the last intervention session
9 secondary outcomes
The Chinese version of the State Anxiety Scale for Children at baseline
Time frame: baseline
change of The Chinese version of the State Anxiety Scale for Children at 9 months from baseline
Time frame: 9 months
change of The Chinese version of the State Anxiety Scale for Children at 12 months from baseline
Time frame: 12 months
The Rosenberg Self-esteem Scale at baseline
Time frame: baseline
change of The Rosenberg Self-esteem Scale at 9 month from baseline
Time frame: 9 months
change of The Rosenberg Self-esteem Scale at 12 month from baseline
Time frame: 12 months
The Pediatric Quality of Life Inventory Generic at baseline
Time frame: baseline
change of The Pediatric Quality of Life Inventory Generic at 9 months from baseline
Time frame: 9 months
change of The Pediatric Quality of Life Inventory Generic at 12 months from baseline
Time frame: 12 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 7 Aug 2015.
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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.
William, Ho Cheung LI, PhD principal investigator
School of Nursing, The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing an adventure-based training programme in people with Healthy, run by The University of 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 1 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The Center for Epidemiologic Studies Depression Scale for Children at baseline (time frame: baseline). The study lists 3 primary outcomes in all. 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 7 Aug 2015.