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Trial registered on ANZCTR
Registration number
ACTRN12607000312448
Ethics application status
Approved
Date submitted
6/06/2007
Date registered
13/06/2007
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
CLIMATE Schools
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Scientific title
CLIMATE Schools: A high school web-based prevention program to prevent the misuse of Alcohol and Cannabis in schools.
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Secondary ID [1]
296709
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol and cannabis misuse
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Condition category
Condition code
Mental Health
1949
1949
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The Intervention Condition - Students in this condition recieve Alcohol and cannabis prevention through the CLIMATE Schools program. This program entails 12 lessons on Alcohol and Cannabis knowledge, use, harms and attitudes. These lessons are taught in year 8 as part of the PDHPE curriculum, replacing existing drug and alcohol preventinon. Each lesson is made up of two parts; the first being reading of cartoons where the students view a group of friends their age experimenting with alcohol and cannabis and learning drug refusal skills. The first part is done via the internet where students logon with individual logins and view the cartoons. The second part of each lesson is run by the teacher and involves class, individual or group activities provided in the manual we give schools.
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Intervention code [1]
1808
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Prevention
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Comparator / control treatment
The Control Condition - Students in this condition recieve their usual PDHPE classes on drug and alcohol.
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Control group
Active
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Outcomes
Primary outcome [1]
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Alcohol and Cannabis Use
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Timepoint [1]
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Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
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Secondary outcome [1]
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Alcohol and Cannabis knowledge
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Timepoint [1]
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Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
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Secondary outcome [2]
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Alcohol and Cannabis attitudes
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Timepoint [2]
4663
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Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
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Secondary outcome [3]
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Alcohol and cannabis harms.
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Timepoint [3]
4664
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Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
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Eligibility
Key inclusion criteria
Year 8 students. Consent to study.
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Minimum age
13
Years
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Maximum age
15
Years
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Gender
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Does not consent.
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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)
This study is a cluster RCT so all students within a particular school will be assigned to the same condition. Schools were randomly allocated to act as control or intervention schools. This was done using an internet randomizing program and again by a blind person who picked them out using sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Internet program called Randomizer
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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
Phase 1
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Type of endpoint(s)
Efficacy
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Statistical methods / analysis
Baseline equivalence and attrition between groups were examined using single-level analyses. A series of one-way analyses of variance were used to analyse normally distributed data, the c2 test to examine binominal data and the Mann–Whitney U-test to examine non-normally distributed data.
To account for intracluster correlations between schools, intervention effects were examined primarily using hierarchical linear modelling (HLM) for normally distributed data (i.e. knowledge and expectancies) and hierarchical generalized linear modelling (HGLM) using a
Poisson sampling method for count data. Outcome variables were centred at post-test to allow for comparisons between groups immediately after the intervention and growth terms were analysed to determine the magnitude of the follow-up effects. Analyses were conducted using
the HLM 6 program [38]. If the unconditional model revealed that less than 10% of systematic variance existed at the between-school level, HLM was abandoned and single-level analyses were used [39]. The outcome variables with intra class correlations (ICCs) below 10% included average weekly alcohol consumption, frequency of drinking to excess, frequency of cannabis use and cannabis-related harms. Although these variables were not distributed normally, in the absence of available nonparametric mixed models Harris [40] recommends that standard ANOVA procedures are robust for skewed and proportional data. For each of these outcome variables ANOVAs utilizing the SPSS generalized linear model (GLM) procedure were conducted on change scores from baseline to each follow-up occasion, as they represented normal distributions more effectively and accounted for baseline differences between groups. Bonferroni adjustments were made for multiple comparisons to control the type 1 error rate.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2007
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
31/12/2006
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Date of last data collection
Anticipated
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Actual
31/12/2008
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Sample size
Target
764
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Accrual to date
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Final
764
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Foundation for Alcohol Research & Education (Alcohol Education and Rehabilitation Foundation)
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Address [1]
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Level 1, 40 Thesiger Court, Deakin ACT 2600
PO Box 19 Deakin West ACT 2600
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Australian Research Council
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Address [2]
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Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
AUSTRALIA
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Country [2]
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Australia
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Primary sponsor type
University
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Name
University of New South Wales (UNSW)
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Address
University of New South Wales (UNSW)
Sydney, NSW, 2052
Australia
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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National Drug and Alcohol Research Centre
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Address [1]
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NDARC, UNSW
Sydney, NSW, 2052
Australia
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales Human Research Ethics Comittee
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Ethics committee address [1]
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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Approval date [1]
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24/06/2006
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Ethics approval number [1]
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06165
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Summary
Brief summary
This RCT is designed to test weather the CLIMATE Schools Alcohol and Cannabis program is more successful in preventing Alcohol and cannabis use and related harms, compared to the current programs
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Trial website
www.climateschools.com.au
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Trial related presentations / publications
Newton, N. C., Vogl, L. E., Teesson, M., & Andrews, G. (2011). Developing the Climate Schools: Alcohol and Cannabis Module: A harm-minimisation, universal drug prevention program delivered over the internet. Substance Use and Misuse, 46 (13), 1654-1663.
Newton, N. C., Teesson, M., Vogl, L. E. & Andrews, G. (2010). Internet-based prevention for alcohol and cannabis use: Final results of the Climate Schools course. Addiction, 105, 749-759.
Newton, N. C., Andrews, G., Teesson, M., & Vogl, L. E. (2009). Delivering school-based prevention for alcohol and cannabis using the internet: A cluster randomised controlled trial. Preventive Medicine, 48, 579-584.
Newton, N. C., Vogl, L. E., Teesson, M., & Andrews, G. (2009). Climate Schools: Alcohol Module: A cross-validation of a school based prevention program for alcohol misuse. Australian and New Zealand Journal of Psychiatry, 43, 201-207.
Newton, N. C., Havard, A., & Teesson, M. (2012). The association between moral disengagement, psychological distress, resistive self-regulatory efficacy, and alcohol and cannabis use among adolescents in Sydney, Australia. Addiction Research & Theory, 20 (3), 261-269.
Vogl, L. E., Newton, N. C., Teesson, M., Swift, W., Karageorge, A. Deans, C., McKetin, R., Steadman, B. Jones, J. Dillon, P. Havard, A., & Andrews, G. (2012). Climate Schools: Drug prevention programs. NDARC Technical Report No. 321. ISBN 978-0-7334-3162-3. Sydney: National Drug and Alcohol Research Centre, UNSW.
Presentations:
Newton, N. C., Teesson, M., Vogl, L. Andrews, G., & Conrod, P. (2011). Effects of the ‘Climate Schools: Alcohol and Cannabis’ course in Australia and the UK. Presented at EABCT conference, Iceland, September 2011
Newton, N. C., Conrod, P. & Teesson, M. (2010). Effective school-based programs to prevent substance misuse, emotional problems and risky behaviour among adolescents. Invited plenary speaker at the VAD conference, Brussels, Belguim, Nov 201
Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2010). Universal drug prevention. Presented at the 6th world conference for the prevention of mental health disorders, Washington DC, US, Nov 2010.
Teesson, M., Newton, N. C., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Prevention for alcohol and cannabis delivered over the internet. Presented at the European Association for Cognitive and Behavioural Therapy, Dubrovnik, Croatia, September, 2009.
Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Delivering prevention for alcohol and cannabis over the internet. Poster presented at the National Drug and Alcohol Research Centre Annual Symposium, Sydney, NSW, Sept 2009.
Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Delivering prevention for alcohol and cannabis over the internet. Poster presented at the National Cannabis Prevention and Information Centre (NCPIC) Conference, Sydney, NSW, Sept 2009.
Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Prevention for alcohol and cannabis delivered over the internet. Poster presented at the Research Society on Alcoholism Conference, San Diego, US, June 2009.
Newton, N. C., & Teesson, M., Andrews, G. & Vogl, L. E. (2009). Delivering prevention for alcohol and cannabis over the internet. Poster presented at the College on Problems of Drug Dependence Conference, Reno, US, June 2009.
Teesson, M., Newton, N. C., Vogl, L. E., & Andrews, G. (2008). Climate Schools: Evaluating the early results of a computerised alcohol and cannabis prevention program for high school. Presented at the Australian Professional Society on Alcohol and other Drugs, Sydney, NSW, Nov, 2008.
Newton, N. C. (2007). Developing a computer-based drug prevention program for adolescents. Presented at the National Drug and Alcohol Research Centre In house seminar, Sydney, NSW, Nov 2008.
Newton, N. C. (2008). Climate Schools: The development and evaluation of a Year 8 computerised evidence-based alcohol and cannabis misuse prevention program. Presented at the National Drug and Alcohol Research Centre Annual Symposium, Sydney, NSW, August 2008.
Vogl, L. E. Teesson, M.., Andrews, G., Newton, N. C., & VanVliet, H. (2007). Developing and implementing effective school-based drug prevention programs: CLIMATE Schools. Presented at the ACHPER National / International Biennial Conference, Perth, WA, December 2007.
Newton, N. C. (2006). Climate Schools: The development of a Year 8 computerised evidence-based alcohol and cannabis misuse prevention program. Presented at the School of Public Health and Community Medicine Student Conference, UNSW, Sydney, NSW, November 2006.
Newton, N. C. & Van Vliet, H. (2006). Climate Schools: The development and evaluation of a computer-based prevention program for adolescents. Presented at Young People’s Health: What’s it going to take Conference, Sydney, NSW, November 2006.
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Public notes
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Contacts
Principal investigator
Name
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Dr Nicola Newton
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Address
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National Drug and Alcohol Research Centre University of New South Wales (UNSW)Randwick NSW2052
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Country
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Australia
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Phone
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+61 2 93850159
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Fax
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Email
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n.newton@unsw.edu.au
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Contact person for public queries
Name
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Dr Nicola Newton
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Address
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National Drug and Alcohol Research Centre
University of New South Wales (UNSW)Randwick NSW2052
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Country
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Australia
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Phone
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+61 2 93850159
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Fax
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Email
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nickien@unsw.edu.au
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Contact person for scientific queries
Name
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Dr Nicola Newton
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Address
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National Drug and Alcohol Research Centre
University of New South Wales (UNSW)
Randwick NSW 2052
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Country
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Australia
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Phone
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+61 2 93850159
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Fax
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Email
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nickien@unsw.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
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Summary results
Have study results been published in a peer-reviewed journal?
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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