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
28/04/2024
Date data sharing statement initially provided
26/11/2018
Date results provided
28/04/2024
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
Sex
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)
Country [1] 2092 0
Australia
Funding source category [2] 2093 0
Government body
Name [2] 2093 0
Australian Research Council
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 10997 0
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
[email protected]
Contact person for scientific queries
Name 1925 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant data supporting the publication results and participant data relating to primary outcomes.
When will data be available (start and end dates)?
Data are available straight after publication.
Data are available for an indefinite time
Start date: April 2024 (approx)
End date: Unknown
Available to whom?
Data are potentially available to:
- Researchers from not-for-profit organisations
Based in:
- Any location
Further information:
All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy (http://www.university.edu/datasharing policy).
Available for what types of analyses?
IPD meta-analysis or systematic review
Assessed on a case-by-case basis
How or where can data be obtained?
As of 22 April 2024, access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.
For further information, see our data sharing policy (http://www.university.edu/datasharing policy).


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.