Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000822684
Ethics application status
Approved
Date submitted
20/07/2014
Date registered
1/08/2014
Date last updated
1/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a salutogenic, occupationally based resiliency and mental wellbeing program (The Boomerang Effect Program) in school students and teachers.
Scientific title
The effectiveness of the Boomerang Effect Program on the resiliency and mental wellbeing of students and teachers.
Secondary ID [1] 285020 0
nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developing resilience in students and teachers, potentially contributing to mental health prevention.
 292534 0
Condition category
Condition code
Public Health 292840 292840 0 0
Health promotion/education
Mental Health 292841 292841 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Boomerang Effect program is a 2 year comprehensive program aimed at developing a range of skills that contribute to resilience and potentially contribute to mental health prevention. The 8 intervention modules are: 1. Positivity 2. Motivation and Best Self 3. Mindfulness 4. Emotion Management 5. Other resiliency skills 6. World Skills 7. Work ethic & Organisation 8. Optimal Environment. The program is flexible and can be delivered as 1-2 longer classes per week or 3 to 5 shorter 10-20 min classes delivered in 'home room' or assembly. Teachers will be teaching the program. Key teachers at each school attend a one off 1 day face-to-face training program with Boomerang Effect developers. These key teachers provide train the trainer sessions for other teachers on staff at their schools.
Intervention code [1] 289854 0
Prevention
Intervention code [2] 289855 0
Lifestyle
Intervention code [3] 289856 0
Behaviour
Comparator / control treatment
The comparison group will be a school with similar population demographics that will complete the standardised measures at the same time points as the intervention group. This comparison school will have the option to implement the program at a later date.
The comparison school will have their normal classes at the same time as the intervention school.
Control group
Active

Outcomes
Primary outcome [1] 292707 0
Primary Outcome 1: Connor-Davidson Resilience Scale 25 (CD-RISC 25); a brief and extensively cited measure of resilience.
Timepoint [1] 292707 0
Students & Teachers will complete the CD-RISC 25 at the commencement and completion of each module and at the same time points for comparison school participants.
Secondary outcome [1] 309530 0
Secondary Outcome 1: Specific measures targeted to skills in each module e.g. for Module 1 “Positivity”, student participants will complete the Life Orientation Test- Revised (LOT-R) LOT-R and Positive Self Questionnaire (PSQ); measures of optimism/positivity and self-efficacy respectively.
Timepoint [1] 309530 0
At the commencement and completion of each specific module and at the same time points for comparison school participants.
Secondary outcome [2] 309531 0
Secondary Outcome 2: Teacher participants and comparison measures: Utrecht Work Engagement Scale (UWES), a reliable and brief measure of the 3 dimensions of work engagement- vigour, dedication and absorption.
Timepoint [2] 309531 0
At the commencement and completion of each module and at the same time points for comparison school participants.
Secondary outcome [3] 309532 0
Secondary Outcome 3: Teacher participants and comparison measures: Teacher Sense of Efficacy Scale (TSES), a highly reliable measure assessing teacher efficacy in student engagement, instructional strategies and classroom management domains.
Timepoint [3] 309532 0
At the commencement and completion of each module and at the same time points for comparison school participants.
Secondary outcome [4] 309533 0
Secondary Outcome 4: Teacher participants and comparison measures: Oldenburg Burnout Inventory (OLBI), a reliable and valid tool measuring two core dimensions of burnout, exhaustion and disengagement.
Timepoint [4] 309533 0
At the commencement and completion of each module and at the same time points for comparison school participants.

Eligibility
Key inclusion criteria
Students that are taught the program will be invited to participate in the study.
Students in comparison schools will be invited to participate in the study.
Teachers that are teaching the program will be invited to participate in the study.
Teachers in comparison schools will be invited to participate in the study
Minimum age
11 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No specific exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis question will be: “Do participants in the intervention groups show significantly more positive outcomes than participants in comparison groups?”
For the quantitative pilot phase of the study, we will aim to recruit 250 student and 30 teacher participants as this is an average pilot study sample size. It will allow for trends to emerge and is adequate to assess statistical difference pre/post intervention modules.
Differences between groups (intervention and comparison groups) and in individuals over time (e.g. Pre-test and post-test) will be examined in a variety of ways including repeated measures t-tests and analyses of co-variance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2014
Actual
Date of last participant enrolment
Anticipated
21/05/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8455 0
2195 - Lakemba
Recruitment postcode(s) [2] 8456 0
2566 - Varroville
Recruitment postcode(s) [3] 8457 0
2212 - Revesby

Funding & Sponsors
Funding source category [1] 289634 0
Self funded/Unfunded
Name [1] 289634 0
Country [1] 289634 0
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Faculty of Health Sciences,
Cumberland Campus
Lidcombe, NSW 2141
Country
Australia
Secondary sponsor category [1] 288320 0
Other
Name [1] 288320 0
Catholic Education Office Wollongong Diocese
Address [1] 288320 0
86-88 Market Street
Wollongong, NSW, 2500.
Country [1] 288320 0
Australia
Secondary sponsor category [2] 288321 0
Other
Name [2] 288321 0
Catholic Education Office Sydney Diocese
Address [2] 288321 0
38 Renwick Street
P.O. Box 217 Leichhardt, NSW 2040
Country [2] 288321 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291373 0
The University Of Sydney Human Research Ethics Committee
Ethics committee address [1] 291373 0
Ethics committee country [1] 291373 0
Australia
Date submitted for ethics approval [1] 291373 0
Approval date [1] 291373 0
21/05/2014
Ethics approval number [1] 291373 0
2014/333
Ethics committee name [2] 291374 0
Catholic Education Office Wollongong Diocese
Ethics committee address [2] 291374 0
Ethics committee country [2] 291374 0
Australia
Date submitted for ethics approval [2] 291374 0
Approval date [2] 291374 0
29/05/2014
Ethics approval number [2] 291374 0
Ethics committee name [3] 291375 0
Catholic Education Office Sydney Diocese
Ethics committee address [3] 291375 0
Ethics committee country [3] 291375 0
Australia
Date submitted for ethics approval [3] 291375 0
Approval date [3] 291375 0
11/07/2014
Ethics approval number [3] 291375 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 131 131 0 0
/AnzctrAttachments/366758-2014_333 Approval Ethics sydney uni 20.5.2014Scanlan App A.pdf
Attachments [2] 132 132 0 0
/AnzctrAttachments/366758-CEO Wollongong Boomerang Effect Ethics Approaval 29.5.2014.pdf
Attachments [3] 133 133 0 0
/AnzctrAttachments/366758-CEO Sydney Boomerang Effect Ethics Approval 11.7.2014.pdf

Contacts
Principal investigator
Name 50090 0
Dr Justin Scanlan
Address 50090 0
Room J120
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141 Australia
Country 50090 0
Australia
Phone 50090 0
+61 2 9351 9022
Fax 50090 0
+61 2 9351 9197
Email 50090 0
[email protected]
Contact person for public queries
Name 50091 0
Theresa Novak
Address 50091 0
c/- Justin Scanlan
J Block
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141 Australia
Country 50091 0
Australia
Phone 50091 0
+61 425 278787
Fax 50091 0
Email 50091 0
[email protected]
Contact person for scientific queries
Name 50092 0
Justin Scanlan
Address 50092 0
Room J120
C42 - Cumberland Campus
The University of Sydney
Lidcombe
NSW 2141 Australia
Country 50092 0
Australia
Phone 50092 0
+61 2 9351 9022
Fax 50092 0
Email 50092 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.