Trial Review

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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
Scientific title
CLIMATE Schools: A high school web-based prevention program to prevent the misuse of Alcohol and Cannabis in schools.
Secondary ID [1] 296709 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and cannabis misuse 1855 0
Condition category
Condition code
Mental Health 1949 1949 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1808 0
Prevention
Comparator / control treatment
The Control Condition - Students in this condition recieve their usual PDHPE classes on drug and alcohol.
Control group
Active

Outcomes
Primary outcome [1] 2767 0
Alcohol and Cannabis Use
Timepoint [1] 2767 0
Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
Secondary outcome [1] 4662 0
Alcohol and Cannabis knowledge
Timepoint [1] 4662 0
Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
Secondary outcome [2] 4663 0
Alcohol and Cannabis attitudes
Timepoint [2] 4663 0
Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.
Secondary outcome [3] 4664 0
Alcohol and cannabis harms.
Timepoint [3] 4664 0
Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.

Eligibility
Key inclusion criteria
Year 8 students. Consent to study.
Minimum age
13 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Does not consent.

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)
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Internet program called Randomizer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
31/12/2006
Date of last data collection
Anticipated
Actual
31/12/2008
Sample size
Target
764
Accrual to date
Final
764
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 2092 0
Charities/Societies/Foundations
Name [1] 2092 0
Foundation for Alcohol Research & Education (Alcohol Education and Rehabilitation Foundation)
Address [1] 2092 0
Level 1, 40 Thesiger Court, Deakin ACT 2600
PO Box 19 Deakin West ACT 2600
Country [1] 2092 0
Australia
Funding source category [2] 2093 0
Government body
Name [2] 2093 0
Australian Research Council
Address [2] 2093 0
Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
AUSTRALIA
Country [2] 2093 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
University of New South Wales (UNSW)
Sydney, NSW, 2052
Australia
Country
Australia
Secondary sponsor category [1] 1899 0
University
Name [1] 1899 0
National Drug and Alcohol Research Centre
Address [1] 1899 0
NDARC, UNSW
Sydney, NSW, 2052
Australia
Country [1] 1899 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3882 0
University of New South Wales Human Research Ethics Comittee
Ethics committee address [1] 3882 0
Ethics committee country [1] 3882 0
Australia
Date submitted for ethics approval [1] 3882 0
Approval date [1] 3882 0
24/06/2006
Ethics approval number [1] 3882 0
06165

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
Trial website
www.climateschools.com.au
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.
Public notes

Contacts
Principal investigator
Name 27911 0
Dr Nicola Newton
Address 27911 0
National Drug and Alcohol Research Centre University of New South Wales (UNSW)Randwick NSW2052
Country 27911 0
Australia
Phone 27911 0
+61 2 93850159
Fax 27911 0
Email 27911 0
n.newton@unsw.edu.au
Contact person for public queries
Name 10997 0
Dr Nicola Newton
Address 10997 0
National Drug and Alcohol Research Centre
University of New South Wales (UNSW)Randwick NSW2052
Country 10997 0
Australia
Phone 10997 0
+61 2 93850159
Fax 10997 0
Email 10997 0
nickien@unsw.edu.au
Contact person for scientific queries
Name 1925 0
Dr Nicola Newton
Address 1925 0
National Drug and Alcohol Research Centre
University of New South Wales (UNSW)
Randwick NSW 2052
Country 1925 0
Australia
Phone 1925 0
+61 2 93850159
Fax 1925 0
Email 1925 0
nickien@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary