Trial Review

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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
9/12/2013
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
Scientific title
The effect of a school-based resilience intervention versus standard school practice on student tobacco, alcohol use levels, and mental health
Secondary ID [1] 262342 0
Nil
Universal Trial Number (UTN)
U1111-1122-0591
Trial acronym
Healthy Schools, Healthy Futures
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent tobacco use 268042 0
Adolescent alcohol use 268043 0
Adolescent mental health 290691 0
Condition category
Condition code
Public Health 268178 268178 0 0
Health promotion/education
Mental Health 268179 268179 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 266729 0
Prevention
Intervention code [2] 266730 0
Behaviour
Intervention code [3] 266731 0
Lifestyle
Comparator / control treatment
No treatment – standard school practices
Control group
Active

Outcomes
Primary outcome [1] 266921 0
Tobacco use measured by adolescent self report
Timepoint [1] 266921 0
At baseline (2011) and at the end of the intervention period (2014)
Primary outcome [2] 266922 0
Alcohol use measured by adolescent self report
Timepoint [2] 266922 0
At baseline (2011) and at the end of the intervention period (2014)
Primary outcome [3] 291058 0
Primary outcome 3: Mental health measured by the youth self-report version of the Strength and Difficulties Questionnaire (SDQ).
Timepoint [3] 291058 0
Timepoint: at baseline (2001) and at the end of the intervention period (2014).
Secondary outcome [1] 276627 0
Resilience factors score measured by adolescent self report
Timepoint [1] 276627 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [2] 276628 0
Marijuana use measured by adolescent self report
Timepoint [2] 276628 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [3] 276629 0
Other drug use measured by adolescent self report
Timepoint [3] 276629 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [4] 276630 0
Physical activity level measured by adolescent self report
Timepoint [4] 276630 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [5] 276631 0
Consumption of fruit measured by adolescent self report
Timepoint [5] 276631 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [6] 276632 0
Consumption of vegetables measured by adolescent self report
Timepoint [6] 276632 0
At baseline (2011) and at the end of the intervention period (2014)
Secondary outcome [7] 276633 0
Sexual activity measured by adolescent self report
Timepoint [7] 276633 0
At baseline (2011) and at the end of the intervention period (2014)

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
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
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.
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.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2011
Actual
27/07/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4071 0
2280
Recruitment postcode(s) [2] 4072 0
2281
Recruitment postcode(s) [3] 4073 0
2284
Recruitment postcode(s) [4] 4074 0
2285
Recruitment postcode(s) [5] 4075 0
2286
Recruitment postcode(s) [6] 4076 0
2287
Recruitment postcode(s) [7] 4077 0
2289
Recruitment postcode(s) [8] 4078 0
2290
Recruitment postcode(s) [9] 4079 0
2298
Recruitment postcode(s) [10] 4080 0
2299
Recruitment postcode(s) [11] 4081 0
2304
Recruitment postcode(s) [12] 4082 0
2320
Recruitment postcode(s) [13] 4083 0
2321
Recruitment postcode(s) [14] 4084 0
2322
Recruitment postcode(s) [15] 4085 0
2323
Recruitment postcode(s) [16] 4086 0
2324
Recruitment postcode(s) [17] 4087 0
2333
Recruitment postcode(s) [18] 4088 0
2336
Recruitment postcode(s) [19] 4089 0
2337
Recruitment postcode(s) [20] 4090 0
2340
Recruitment postcode(s) [21] 4091 0
2350
Recruitment postcode(s) [22] 4092 0
2360
Recruitment postcode(s) [23] 4093 0
2390
Recruitment postcode(s) [24] 4094 0
2420
Recruitment postcode(s) [25] 4095 0
2428
Recruitment postcode(s) [26] 4096 0
2430

Funding & Sponsors
Funding source category [1] 267217 0
Government body
Name [1] 267217 0
National Health and Medical Research Council
Country [1] 267217 0
Australia
Funding source category [2] 267218 0
Charities/Societies/Foundations
Name [2] 267218 0
nib Foundation
Country [2] 267218 0
Australia
Funding source category [3] 267219 0
Government body
Name [3] 267219 0
Hunter New England Population Health
Country [3] 267219 0
Australia
Funding source category [4] 267220 0
Other Collaborative groups
Name [4] 267220 0
Hunter Medical Research Institute
Country [4] 267220 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 266286 0
Government body
Name [1] 266286 0
Hunter New England Population Health
Address [1] 266286 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 266286 0
Australia
Other collaborator category [1] 252043 0
Other
Name [1] 252043 0
New South Wales Department of Education and Communities
Address [1] 252043 0
35 Bridge Street
Sydney NSW 2000
Country [1] 252043 0
Australia
Other collaborator category [2] 252044 0
Other
Name [2] 252044 0
Armidale Catholic Schools Office
Address [2] 252044 0
PO Box 636
Armidale NSW 2350
Country [2] 252044 0
Australia
Other collaborator category [3] 252045 0
Other
Name [3] 252045 0
Maitland Newcastle Catholic Schools Office
Address [3] 252045 0
PO Box 714
Newcastle NSW 2300
Country [3] 252045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269211 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269211 0
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 269211 0
Australia
Date submitted for ethics approval [1] 269211 0
Approval date [1] 269211 0
18/12/2009
Ethics approval number [1] 269211 0
09/11/18/4.01
Ethics committee name [2] 269212 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 269212 0
Callaghan NSW 2308
Ethics committee country [2] 269212 0
Australia
Date submitted for ethics approval [2] 269212 0
Approval date [2] 269212 0
07/10/2010
Ethics approval number [2] 269212 0
H-2010-0029
Ethics committee name [3] 269213 0
Aboriginal Health and Medical Research Council of New South Wales
Ethics committee address [3] 269213 0
PO Box 1565
Strawberry Hills NSW 2012
Ethics committee country [3] 269213 0
Australia
Date submitted for ethics approval [3] 269213 0
Approval date [3] 269213 0
14/03/2011
Ethics approval number [3] 269213 0
Ref 776/11

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.
Trial website
Trial related presentations / publications
Freund M, Campbell E, Wolfenden L, Bowman J, Hodder R, Gillham K, Wiggers J. Healthy Schools, Healthy Futures: implementing resilience intervention using the Health Promoting Schools framework. Australian Health Promoting Schools 8th National Conference; October 2010; Perth, Australia.

Hodder R, Freund M, Daly J, Campbell E, Wolfenden L, Bowman J, Gillham K, Hazell T, Wiggers J. A school-based resilience intervention to decrease adolescent tobacco, alcohol and marijuana use: pilot results and study protocol for RCT. 6th International Drugs and Young People Conference; May 2011; Melbourne Australia.
Public notes

Contacts
Principal investigator
Name 32717 0
Prof John Wiggers
Address 32717 0
Hunter New England Population Health Locked Bag 10 Wallsend NSW 2287
Country 32717 0
Australia
Phone 32717 0
+61 2 4924 6247
Fax 32717 0
+61 2 4924 6209
Email 32717 0
John.wiggers@hnehealth.nsw.gov.au
Contact person for public queries
Name 15964 0
Prof John Wiggers
Address 15964 0
Hunter New England Population Health
Locked Bag 10 Wallsend NSW 2287
Country 15964 0
Australia
Phone 15964 0
+61 2 4924 6247
Fax 15964 0
+61 2 4924 6209
Email 15964 0
John.wiggers@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 6892 0
Prof John Wiggers
Address 6892 0
Hunter New England Population Health
Locked Bag 10
Wallsend NSW 2287
Country 6892 0
Australia
Phone 6892 0
+61 2 4924 6247
Fax 6892 0
+61 2 4924 6209
Email 6892 0
john.wiggers@hnehealth.nsw.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseMental health problems in a regional population of Australian adolescents: Association with socio-demographic characteristics.2016https://dx.doi.org/10.1186/s13034-016-0120-9
EmbaseEffectiveness of a pragmatic school-based universal intervention targeting student resilience protective factors in reducing mental health problems in adolescents.2017https://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.