Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001405202
Ethics application status
Approved
Date submitted
18/08/2018
Date registered
21/08/2018
Date last updated
21/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wellbeing warriors: Examining the effects of martial art training on mental health outcomes for secondary school students
Scientific title
Wellbeing warriors: Examining the effects of martial art training on mental health outcomes: A randomised controlled trial of a secondary school-based mental health promotion program
Secondary ID [1] 295848 0
None
Universal Trial Number (UTN)
U1111-1219-1565
Trial acronym
WW
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Resilience
309299 0
Self-efficacy
309300 0
Emotional problems
 309301 0
Behaviour/conduct problems
 309302 0
Attention problems
 309303 0
Peer/social problems
309304 0
Condition category
Condition code
Mental Health 308170 308170 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 308171 308171 0 0
Anxiety
Mental Health 308172 308172 0 0
Depression
Public Health 308173 308173 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: A randomised controlled trial of a secondary school-based mental health promotion program based on martial arts training.
Material: Martial arts belts (white and yellow), training equipment (strike paddles, strike shields).
Procedures:
(a) Each intervention session includes:
- Psycho-education – guided group based discussion. Topics include respect; self-image (concept) and self-esteem; goal-setting; courage; anger; resilience; bullying/peer pressure; self-care and caring for others; values, optimism & hope;
- Warm up (e.g. jogging, star jumps, push ups, sit ups);
- Stretching (e.g hamstring stretch, triceps stretch, figure four stretch, butterfly stretch, lunging hip flexor stretch, knee to chest stretch, standing quad stretch); and
- Technical practice – stances, blocks, punching, kicking.
(b) Intervention sessions intermittently include (alternated throughout the program):
- Patterns practice,
- Sparring – based on "sticking hands" (tai chi exercise), and
- Meditation – breath focusing exercise.
Note – aggressive physical contact is not part of the intervention program.
Who: Intervention delivered by (1) registered psychologist with minimum 6 years’ experience, (2) 2nd Dan/level black-belt taekwondo instructor with minimum 5 years’ experience.
Mode of delivery: Group format, face to face.
Number of times/dose: 10 x 50-60 minute sessions; once/week for 10 weeks.
Location: High school.
Group size: 15-20 participants.
Intervention code [1] 312185 0
Prevention
Intervention code [2] 312186 0
Treatment: Other
Intervention code [3] 312187 0
Behaviour
Comparator / control treatment
Active control – waitlist control group receives same intervention 2 weeks after the intervention group has completed the intervention.
Number of times/dose: 10 x 50-60 minute sessions; once/week for 10 weeks
Mode of delivery: Group format, face to face.
Control group
Active

Outcomes
Primary outcome [1] 307137 0
Mean total difficulties score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [1] 307137 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Primary timepoint: n/a
Primary outcome [2] 307138 0
Mean total resilience score
Instrument: Child and Youth Resilience Measure (CYRM, Ungar & Liebenberg, 2011)
Timepoint [2] 307138 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Primary timepoint: n/a
Primary outcome [3] 307139 0
Mean total self-efficacy score
Instrument: Self-Efficacy Questionnaire for Children (SEQ-C, Muris, 2001)
Timepoint [3] 307139 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Primary timepoint: n/a
Secondary outcome [1] 350808 0
Mean total emotional score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [1] 350808 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [2] 350809 0
Mean total conduct score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [2] 350809 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [3] 350810 0
Mean total hyperactivity score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [3] 350810 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [4] 350811 0
Mean total peer score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [4] 350811 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [5] 350812 0
Mean total pro-social score
Instrument: Strengths and Difficulties Questionnaire (SDQ, Goodman, 2005)
Timepoint [5] 350812 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [6] 350813 0
Mean total individual capacities/resources score
Instrument: Child and Youth Resilience Measure (CYRM, Ungar & Liebenberg, 2011)
Timepoint [6] 350813 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [7] 350814 0
Mean total relationships with primary caregivers score
Instrument: Child and Youth Resilience Measure (CYRM, Ungar & Liebenberg, 2011)
Timepoint [7] 350814 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [8] 350815 0
Mean total sense of belonging score
Instrument: Child and Youth Resilience Measure (CYRM, Ungar & Liebenberg, 2011)
Timepoint [8] 350815 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [9] 350816 0
Mean total academic self-efficacy score
Instrument: Self-Efficacy Questionnaire for Children (SEQ-C, Muris, 2001)
Timepoint [9] 350816 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [10] 350817 0
Mean total social self-efficacy score
Instrument: Self-Efficacy Questionnaire for Children (SEQ-C, Muris, 2001)
Timepoint [10] 350817 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)
Secondary outcome [11] 350818 0
Mean total emotional self-efficacy score
Instrument: Self-Efficacy Questionnaire for Children (SEQ-C, Muris, 2001)
Timepoint [11] 350818 0
1 week pre-intervention, 1 week post-intervention, 12 week post-intervention (follow-up)

Eligibility
Key inclusion criteria
Secondary school students
Grades 7 & 8
Minimum age
11 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Concurrent martial arts training participation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical power calculations assumed baseline-posttest expected effect size gain of d = 0.3, and were based on 90% power with alpha levels set at p < 0.05. Minimum completion sample size was calculated as n = 234 (intervention group: n = 117, control group: n = 117).

The collected psychometric test data will be analysed using statistical software Statistical Package for the Social Sciences (SPSS). Data will be consolidated into subscale variables using factor analysis and the internal consistency of each variable will be examined to determine reliability. Items to be included in the scale variables will be added and computed to create composite scores; then recoded to create categorical variables (high and low). Repeated measures univariate analysis of variance (ANOVA), and multivariate analysis of variance (MANOVA) will primarily be used to analyse test data. Interpretation of effect sizes will reflect Cohen's suggested small, medium, and large effect sizes, where partial eta squared sizes are equal to 0.10, 0.25, and 0.40 respectively.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
29/06/2018
Date of last data collection
Anticipated
21/12/2018
Actual
Sample size
Target
293
Accrual to date
Final
283
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300446 0
University
Name [1] 300446 0
Macquarie University
Country [1] 300446 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 299910 0
Individual
Name [1] 299910 0
Dr Stuart Woodcock
Address [1] 299910 0
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country [1] 299910 0
Australia
Secondary sponsor category [2] 299911 0
Individual
Name [2] 299911 0
Dr Dean Dudley
Address [2] 299911 0
School of Education, Faculty of Human Sciences, Macquarie University NSW 2109
Country [2] 299911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301246 0
Macquarie University Human Research Ethics Committee (HREC)
Ethics committee address [1] 301246 0
Ethics committee country [1] 301246 0
Australia
Date submitted for ethics approval [1] 301246 0
23/08/2017
Approval date [1] 301246 0
14/12/2017
Ethics approval number [1] 301246 0
5201700901
Ethics committee name [2] 301247 0
State Education Research Approval Process (SERAP), NSW Department of Education
Ethics committee address [2] 301247 0
Ethics committee country [2] 301247 0
Australia
Date submitted for ethics approval [2] 301247 0
20/12/2017
Approval date [2] 301247 0
06/04/2018
Ethics approval number [2] 301247 0
DOC18/257488
Ethics committee name [3] 301248 0
Catholic Education, Diocese of Parramatta (CEDP)
Ethics committee address [3] 301248 0
Ethics committee country [3] 301248 0
Australia
Date submitted for ethics approval [3] 301248 0
02/03/2018
Approval date [3] 301248 0
28/03/2018
Ethics approval number [3] 301248 0
28032018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86366 0
Mr Brian Moore
Address 86366 0
Macquarie University
School of Education
Faculty of Human Sciences
Macquarie University NSW 2109
Country 86366 0
Australia
Phone 86366 0
61 2 9850 4298
Fax 86366 0
Email 86366 0
[email protected]
Contact person for public queries
Name 86367 0
Brian Moore
Address 86367 0
Macquarie University
School of Education
Faculty of Human Sciences
Macquarie University NSW 2109
Country 86367 0
Australia
Phone 86367 0
61 2 9850 4298
Fax 86367 0
Email 86367 0
[email protected]
Contact person for scientific queries
Name 86368 0
Brian Moore
Address 86368 0
Macquarie University
School of Education
Faculty of Human Sciences
Macquarie University NSW 2109
Country 86368 0
Australia
Phone 86368 0
61 2 9850 4298
Fax 86368 0
Email 86368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.