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Trial registered on ANZCTR
Registration number
ACTRN12611000606987
Ethics application status
Approved
Date submitted
8/06/2011
Date registered
14/06/2011
Date last updated
8/09/2024
Date data sharing statement initially provided
8/09/2024
Date results provided
8/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Healthy Schools, Healthy Futures: a randomised controlled trial to assess the efficacy of a school-based resilience intervention to decrease tobacco and alcohol use in secondary school students
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Scientific title
The effect of a school-based resilience intervention versus standard school practice on student tobacco, alcohol use levels, and mental health
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Secondary ID [1]
262342
0
Nil
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Universal Trial Number (UTN)
U1111-1122-0591
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Trial acronym
Healthy Schools, Healthy Futures
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Adolescent tobacco use
268042
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Adolescent alcohol use
268043
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Adolescent mental health
290691
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Condition category
Condition code
Public Health
268178
268178
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0
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Health promotion/education
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Mental Health
268179
268179
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0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A three year resilience intervention will be implemented in each school in the intervention group inclusive of the following six intervention strategies:
- Implementation of age appropriate resilience curriculum and programs targeting student resilience factors eg resilience linked to curriculum across subjects, use of existing programs such as the Resourceful Adolescent Program.
- Implementation of school policies and practices that impact on student resilience factors eg modification of welfare policies to include resilience, student reward and recognition program
- Modification of the physical and social environment of the school to create a safe and supportive environment where resilience is fostered eg modification of space use, student murals
- Development of partnerships with local organisations and community groups to deliver resilience strategies within the school eg Salvation Army, Aboriginal Community
- Improve access to, and promotion of, health and community services eg youth services, community health
- Implementation of strategies to engage and increase participation of parents and families in school-based activities eg social events, increased opportunity to attend school events
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Intervention code [1]
266729
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Prevention
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Intervention code [2]
266730
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Behaviour
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Intervention code [3]
266731
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Lifestyle
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Comparator / control treatment
No treatment – standard school practices
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Control group
Active
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Outcomes
Primary outcome [1]
266921
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Tobacco use measured by adolescent self report
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Assessment method [1]
266921
0
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Timepoint [1]
266921
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At baseline (2011) and at the end of the intervention period (2014)
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Primary outcome [2]
266922
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Alcohol use measured by adolescent self report
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Assessment method [2]
266922
0
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Timepoint [2]
266922
0
At baseline (2011) and at the end of the intervention period (2014)
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Primary outcome [3]
291058
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Primary outcome 3: Mental health measured by the youth self-report version of the Strength and Difficulties Questionnaire (SDQ).
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Assessment method [3]
291058
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Timepoint [3]
291058
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Timepoint: at baseline (2001) and at the end of the intervention period (2014).
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Secondary outcome [1]
276627
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Resilience factors score measured by adolescent self report
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Assessment method [1]
276627
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Timepoint [1]
276627
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [2]
276628
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Marijuana use measured by adolescent self report
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Assessment method [2]
276628
0
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Timepoint [2]
276628
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [3]
276629
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Other drug use measured by adolescent self report
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Assessment method [3]
276629
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Timepoint [3]
276629
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [4]
276630
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Physical activity level measured by adolescent self report
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Assessment method [4]
276630
0
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Timepoint [4]
276630
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [5]
276631
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Consumption of fruit measured by adolescent self report
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Assessment method [5]
276631
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Timepoint [5]
276631
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [6]
276632
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Consumption of vegetables measured by adolescent self report
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Assessment method [6]
276632
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Timepoint [6]
276632
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At baseline (2011) and at the end of the intervention period (2014)
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Secondary outcome [7]
276633
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Sexual activity measured by adolescent self report
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Assessment method [7]
276633
0
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Timepoint [7]
276633
0
At baseline (2011) and at the end of the intervention period (2014)
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Eligibility
Key inclusion criteria
Schools:
- located in a disadvantaged area (defined by the SEIFA Index of Relative Socio-Economic Advantage/Disadvantage)
- located within the HNE Area Health Service region
- > 400 enrolments
- enrolments in Years 7-10
- co-educational
Children:
- all children in Years 7-10 in participating schools
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Schools:
The following types of schools will be excluded from the trial given their characteristics and the likelihood of a differential effects in these schools:
- fully special needs schools
- central schools (schools with enrolments from Kindergarten to Year 10/12)
- fully selective schools
- boarding schools
- schools already implementing a comprehensive resilience intervention
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools:
Schools will be selected from a current list of all government and Catholic secondary schools in the study area obtained from the Department of Education and Training and from relevant regional Catholic School Offices. The order in which schools will be invited to participate will then be determined using a random number function in Microsoft Excel by an independent statistician. The principals of the first 32 randomly selected eligible secondary schools will be sent a letter informing them about the study and requesting written consent for their school to participate. Within one week from the initial information letters being sent, research staff will contact non-responding principals to answer any questions they may have and to prompt for their reply. Principals that do not reply within a further week will receive additional prompts from research staff. If a school declines to consent the next school on the list will be invited, following the same procedure above.
Once 32 schools have been recruited to the study, the sample will be stratified by current receipt of National Partnership Payment funding (low socio-economic schools are provided between AUS$1,000-1,500 per student for four years to improve student wellbeing (REF)) and school size (medium sized school 400-800; large sized school >800). Twenty schools will then be randomly allocated to the intervention group and 12 to the control group by a statistician (using a random number function in SAS 9.2) using proportional random allocation.
Children:
Active parental consent will be required for child participation in the data collection part of the trial. In order to maximise parental consent for child participation, schools will be provided with information regarding the study to disseminate via existing school communication channels, including school newsletters, assemblies, staff meetings, and school community and parent groups. Parents will be given study information packs that include a short letter from the school principal on school letterhead, a detailed study information letter for parents, a simplified study information letter for students, a parental consent form for child participation and a reply paid envelope. Parents will be asked to return the consent form by either using the reply paid envelope, or directly to their child’s school. Two weeks after distribution of the information packs, non-responding parents will be telephoned by school staff to prompt return of the child consent form.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible schools will be randomly selected from the list, and the order in which they are approached to participate will also be randomly determined (using a random number function in Excel) by a statistician.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/07/2011
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Actual
27/07/2011
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Date of last participant enrolment
Anticipated
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Actual
30/09/2014
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Date of last data collection
Anticipated
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Actual
6/12/2014
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Sample size
Target
16000
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Accrual to date
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Final
10092
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
4071
0
2280
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Recruitment postcode(s) [2]
4072
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2281
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Recruitment postcode(s) [3]
4073
0
2284
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Recruitment postcode(s) [4]
4074
0
2285
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Recruitment postcode(s) [5]
4075
0
2286
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Recruitment postcode(s) [6]
4076
0
2287
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Recruitment postcode(s) [7]
4077
0
2289
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Recruitment postcode(s) [8]
4078
0
2290
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Recruitment postcode(s) [9]
4079
0
2298
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Recruitment postcode(s) [10]
4080
0
2299
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Recruitment postcode(s) [11]
4081
0
2304
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Recruitment postcode(s) [12]
4082
0
2320
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Recruitment postcode(s) [13]
4083
0
2321
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Recruitment postcode(s) [14]
4084
0
2322
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Recruitment postcode(s) [15]
4085
0
2323
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Recruitment postcode(s) [16]
4086
0
2324
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Recruitment postcode(s) [17]
4087
0
2333
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Recruitment postcode(s) [18]
4088
0
2336
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Recruitment postcode(s) [19]
4089
0
2337
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Recruitment postcode(s) [20]
4090
0
2340
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Recruitment postcode(s) [21]
4091
0
2350
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Recruitment postcode(s) [22]
4092
0
2360
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Recruitment postcode(s) [23]
4093
0
2390
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Recruitment postcode(s) [24]
4094
0
2420
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Recruitment postcode(s) [25]
4095
0
2428
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Recruitment postcode(s) [26]
4096
0
2430
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Funding & Sponsors
Funding source category [1]
267217
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Government body
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Name [1]
267217
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National Health and Medical Research Council
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Address [1]
267217
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GPO Box 1421
Canberra ACT 2601
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Country [1]
267217
0
Australia
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Funding source category [2]
267218
0
Charities/Societies/Foundations
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Name [2]
267218
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nib Foundation
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Address [2]
267218
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Locked Bag 2010
Newcastle NSW 2300
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Country [2]
267218
0
Australia
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Funding source category [3]
267219
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Government body
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Name [3]
267219
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Hunter New England Population Health
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Address [3]
267219
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Locked Bag 10
Wallsend NSW 2287
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Country [3]
267219
0
Australia
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Funding source category [4]
267220
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Other Collaborative groups
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Name [4]
267220
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Hunter Medical Research Institute
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Address [4]
267220
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Locked Bag 1
Hunter Region Mail Centre NSW 2310
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Country [4]
267220
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Australia
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Primary sponsor type
University
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Name
The University of Newcastle
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Address
Callaghan NSW 2308
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Country
Australia
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Secondary sponsor category [1]
266286
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Government body
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Name [1]
266286
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Hunter New England Population Health
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Address [1]
266286
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Locked Bag 10
Wallsend NSW 2287
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Country [1]
266286
0
Australia
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Other collaborator category [1]
252043
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Other
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Name [1]
252043
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New South Wales Department of Education and Communities
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Address [1]
252043
0
35 Bridge Street
Sydney NSW 2000
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Country [1]
252043
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Australia
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Other collaborator category [2]
252044
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Other
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Name [2]
252044
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Armidale Catholic Schools Office
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Address [2]
252044
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PO Box 636
Armidale NSW 2350
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Country [2]
252044
0
Australia
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Other collaborator category [3]
252045
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Other
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Name [3]
252045
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Maitland Newcastle Catholic Schools Office
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Address [3]
252045
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PO Box 714
Newcastle NSW 2300
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Country [3]
252045
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
269211
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
269211
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Hunter New England Health Locked Bag 1 New Lambton NSW 2305
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Ethics committee country [1]
269211
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Australia
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Date submitted for ethics approval [1]
269211
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Approval date [1]
269211
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18/12/2009
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Ethics approval number [1]
269211
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09/11/18/4.01
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Ethics committee name [2]
269212
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The University of Newcastle Human Research Ethics Committee
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Ethics committee address [2]
269212
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Callaghan NSW 2308
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Ethics committee country [2]
269212
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Australia
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Date submitted for ethics approval [2]
269212
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Approval date [2]
269212
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07/10/2010
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Ethics approval number [2]
269212
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H-2010-0029
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Ethics committee name [3]
269213
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Aboriginal Health and Medical Research Council of New South Wales
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Ethics committee address [3]
269213
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PO Box 1565 Strawberry Hills NSW 2012
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Ethics committee country [3]
269213
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Australia
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Date submitted for ethics approval [3]
269213
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Approval date [3]
269213
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14/03/2011
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Ethics approval number [3]
269213
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Ref 776/11
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Summary
Brief summary
A cluster randomised controlled trial study is proposed in 32 schools to test the efficacy of a comprehensive three year resilience intervention in decreasing the self reported health risk behaviours of secondary school students. Twenty schools will be randomly allocated to the intervention group and a further 12 schools randomly allocated to the control group. For evaluation purposes, web-based surveys will be conducted with a cohort of students in grade 7 attending both intervention and control schools at baseline (prior to intervention delivery), and three years after baseline data collection when the cohort are in grade 10. The surveys will include measures of self-reported health risk behaviours (including tobacco, alcohol, marijuana and other illicit drug use; nutritional intake, physical activity and sexual practices for those students in grade 10) risk of mental health problems, as well as student resilience scores. Comparisons will be made at follow up between grade 10 students in intervention and control schools to examine any differential changes in student health risk behaviours, risk of mental health problems, and resilience scores.
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Trial website
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Trial related presentations / publications
Hodder RK, Lee H, Kamper S, Wiggers JH, Williams CM. Effectiveness of a universal school-based ‘resilience’ intervention in reducing pain in adolescents: a cluster-randomised controlled trial. International Journal of Behavioral Medicine, 2018. 25 (Suppl 1): S105. DOI: 10.1007/s12529-018-9740-1* Hodder RK, Campbell E, Gilligan C, Lee H, Lecathinlinais C, Green S, MacDonald M, Wiggers JH. Consistency of associations between adolescent tobacco and alcohol use risk and protective factors. International Journal of Behavioral Medicine, 2018. 25 (Suppl 1): S149. DOI: 10.1007/s12529-018-9740-1* Hodder RK, Freund M, Bowman J, Campbell E, Wolfenden L, Dray J, Lecathelinais C, Oldmeadow C, Attia J, Wiggers. Effectiveness of a universal school-based intervention in reducing adolescent tobacco, alcohol and illicit substance use: exploratory assessment of effect by student socio-demographic and substance use initiation. BMJ Open 2018; 8 (8):e021047. DOI: 10.1136/bmjopen-2017-021047 Hodder RK, Homer S, Freund M, Bowman J, Lecathelinais C, Colyvas K, Campbell E, Gillham K, Dray J, Wiggers J. The association between adolescent condom use and individual and environmental resilience protective factors. Australia and New Zealand Journal of Public Health, 2018; 42 (3): 230-233. DOI: 10.1111/1753-6405.12744 Hodder RK, Campbell E, Gilligan C, Lee H, Lecathelinais C, Wiggers J. Association between Australian adolescent alcohol use and alcohol use risk and protective factors, 2011 and 2014. Drug and Alcohol Review 2018, 42(3):230-233 (Invited submission for special issue on the decline in youth drinking). 10.1111/dar.12623 McLaren N, Kamper SJ, Hodder R, Wiggers J, Wolfenden L, Bowman J, Campbell E, Dray J, Williams C. Increased substance use and poorer mental health in adolescents with problematic musculoskeletal pain. Journal of Orthopaedic and Sports Physical Therapy, 2017. 47(10):705-711. DOI: 10.2519/jospt.2017.7441. Hodder RK, Freund M, Bowman J, Wolfenden L, Campbell E, Dray J, Lecathelinais C, Oldmeadow C, Attia J, Wiggers J. Effectiveness of a pragmatic school-based universal resilience intervention in reducing tobacco, alcohol and illicit substance use in a population of adolescents: cluster-randomised controlled trial BMJ Open 2017;7:e016060. doi: 10.1136/bmjopen-2017-016060. Hodder RK, Wolfenden L. Comparison of online and paper survey secondary school parent response rates in a child health survey. Australia and New Zealand Journal of Public Health, 2017; 41 (5). doi: 10.1111/1753-6405.12682. Dray J, Bowman J, Campbell E, Freund M, Hodder RK, Wolfenden L, Richards J, Leane C, Green S, Lecathelinais C, Oldmeadow C, Attia J, Gillham K, Wiggers J. Effectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents. Journal of Adolescence 2017, 57: 74-89. http://dx.doi.org/10.1016/j.adolescence.2017.03.009 Hodder RK, Freund M, Bowman J, Wolfenden L, Gillham K, Dray J, Wiggers J. Association between adolescent tobacco, alcohol and illicit drug use and individual and environmental resilience protective factors. BMJ Open 2016;6:e012688. doi:10.1136/bmjopen-2016- 012688 Dray J, Bowman J, Freund M, Campbell E, Hodder R, Lecathelinais C, Wiggers J. Mental health problems in a regional population of Australian adolescents: association with socio-demographic characteristics. Child and Adolescent Psychiatry and Mental Health, 2016, 10(32):1-11. DOI:10.1186/s13034-016-0120-9. Hodder RK, Freund M, Bowman J, Wolfenden L, Campbell E, Dray J, Lecathelinais C, Oldmeadow C, Attia J, Wiggers J. Effectiveness of a school-based protective factor intervention in reducing adolescent tobacco, alcohol and illicit substance use. International Journal of Behavioral Medicine 2016; 23(S1): S90.* Hodder RK, Freund M, Bowman J, Wolfenden L, Campbell E, Dray J, Lecathelinais C, Oldmeadow C, Attia J, Wiggers J. Effectiveness of a universal school-based intervention in reducing adolescent tobacco, alcohol and illicit substance use within student subgroups: exploratory assessment. International Journal of Behavioral Medicine 2016; 23(S1): S91.* Dray J, Bowman J, Campbell E, Freund M, Wiggers J, Wolfenden L, Hodder R, Gillham K. Exploring the potential of a school-based intervention in Australia on mental health problems and resilience in adolescents: a cluster randomised trial. Journal of the Canadian Academy of Child and Adolescent Psychiatry 2016; 25(S1): O23.2 (pp. 68).* Dray J, Bowman J, Freund M, Campbell E, Hodder R, Lecathelinais C, Gillham K, Wiggers J. Mental health problems in a regional population of Australian adolescents: association with socio-demographic characteristics. Journal of the Canadian Academy of Child and Adolescent Psychiatry 2016; 25(S1); O09.4. (pp. 26).* Dray J, Bowman J, Freund M, Campbell L, Wolfenden L, Hodder R, Wiggers J. Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a cluster randomised trial. Trials, 2014; 15:289. Hodder RK, Freund M, Bowman J, Wolfenden L, Gillham K, Dray J, Wiggers J. Tobacco, alcohol and illicit drug use in adolescents: does resilience matter? International Journal of Behavioral Medicine 2014; 21(S1): S153.* Dray J, Freund M, Bowman J, Campbell E, Wiggers J, Wolfenden L, Hodder R, Gillham K. Mental health and resilience in adolescence: a resilience-based intervention. International Journal of Behavioral Medicine 2014; 21(S1): S203.* Dray J, Freund M, Bowman J, Campbell E, Hodder RK, Wiggers J, Gillham K. The mental health of adolescents: What differences exist? International Journal of Behavioural Medicine 2014; 21(S1): S22.* Hodder RK, Freund M, Bowman J, Wolfenden L, Campbell E, Wye P, Hazell T, Gillham K, Wiggers J. A cluster randomised trial of a school-based resilience intervention to decrease tobacco, alcohol and illicit drug use in secondary school students: study protocol. BMC Public Health, 2012; 12: 1009. *Published conference abstract
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Public notes
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Contacts
Principal investigator
Name
32717
0
Prof John Wiggers
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Address
32717
0
Hunter New England Population Health Locked Bag 10 Wallsend NSW 2287
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Country
32717
0
Australia
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Phone
32717
0
+61 2 4924 6247
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Fax
32717
0
+61 2 4924 6209
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Email
32717
0
John.wiggers@health.nsw.gov.au
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Contact person for public queries
Name
15964
0
John Wiggers
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Address
15964
0
Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
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Country
15964
0
Australia
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Phone
15964
0
+61 2 4924 6247
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Fax
15964
0
+61 2 4924 6209
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Email
15964
0
John.wiggers@health.nsw.gov.au
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Contact person for scientific queries
Name
6892
0
John Wiggers
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Address
6892
0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
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Country
6892
0
Australia
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Phone
6892
0
+61 2 4924 6247
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Fax
6892
0
+61 2 4924 6209
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Email
6892
0
John.wiggers@health.nsw.gov.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
Mental health problems in a regional population of Australian adolescents: Association with socio-demographic characteristics.
2016
https://dx.doi.org/10.1186/s13034-016-0120-9
Embase
Effectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents.
2017
https://dx.doi.org/10.1016/j.adolescence.2017.03.009
N.B. These documents automatically identified may not have been verified by the study sponsor.
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