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Trial registered on ANZCTR


Registration number
ACTRN12613000492752
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
2/05/2013
Date last updated
2/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the CLIMATE Schools: Psychostimulant and Cannabis Module. A cluster randomised controlled trial in Australian secondary schools.
Scientific title
An evaluation of the CLIMATE Schools: Psychostimulant and Cannabis Module. A cluster randomised controlled trial in Australian secondary schools.
Secondary ID [1] 282407 0
Nil known
Universal Trial Number (UTN)
U1111-1142-4053
Trial acronym
The CLIMATE Schools: Psychostimulant and Cannabis Module
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotimulant use 288989 0
Condition category
Condition code
Public Health 289330 289330 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CLIMATE Schools: Psychostimulant and Cannabis Module consists of a six-lesson harm-minimisation program aimed at decreasing cannabis and psychostimulant use, misuse and related harms. The lessons are intended to be delivered once weekly over a six week period. Each lesson is approximately 40 minutes in length and is broken into two components. The first is a 15-20 minute computer module. The second part involves the choice of one or more classroom-based activities which have been prepared in the program manual. Teacher and student summary sheets are also provided for each lesson.

The online intervention requires students to complete the lessons in consecutive order to ensure they view each lesson in full before moving to the next.
Intervention code [1] 287040 0
Prevention
Comparator / control treatment
Participants in the control group received their usual health classes at school over the year including drug and alcohol educations.
Control group
Active

Outcomes
Primary outcome [1] 289444 0
Knowledge about cannabis:
Cannabis related knowledge was measured by a 15-item survey which assesses students’ knowledge of cannabis in relation to the drug itself, prevalence of use, physical and mental health, legal consequences and information required to minimise the harm associated with cannabis use. For each of the 15 statements concerning cannabis the students were required to indicate whether the statement was ‘true’, ‘false’ or whether they ‘don’t know’. Each correct answer was given a score of 1, giving the total score for this survey a possible range of 0-15. All knowledge assessed in this survey was covered in the CLIMATE Schools: Psychostimulant and Cannabis Use Module.

Knowledge about psychostimulants:
Psychostimulant related knowledge was measured with a 15-item survey which assesses students’ knowledge of psychostimulants in relation to the drug itself, prevalence of use, physical and mental health, legal consequences and information required to minimise the harm associated with psychostimulant use. For each of the 15 statements concerning psychostimulants, the students were required to indicate whether the statement was ‘true’, ‘false’ or whether they ‘don’t know’. Each correct answer was given a score of 1, giving the total score for this survey a possible range of 0-15. This questionnaire was specifically developed for this project and designed to assess the content covered in the CLIMATE Schools: Psychostimulant and Cannabis Use Module.


Timepoint [1] 289444 0
5 month follow-up
Primary outcome [2] 289445 0
Attitudes to cannabis and psychostimulant use:
Attitudes to Cannabis and Psychostimulants use were assessed using an adapted version of the Life Skills Training Questionnaire (LSTQ). Four items were used to assess attitudes to cannabis use, such as the perceived social benefits of using cannabis, with responses made on a five-point likert scale, anchored by 1 (‘strongly disagree’) to 5 (‘strongly agree’). Attitudes to psychostimulants were measured using the same four items with ‘psychostimulants’ inserted in place of ‘cannabis’.
Timepoint [2] 289445 0
5 month follow-up
Secondary outcome [1] 302487 0
Psychostimulant and cannabis use:

The Cannabis Use Questionnaire: addresses the following areas: (1) proportion of friends and acquaintances using cannabis, (2) ever used, (3) age of initiation, and (4) use in past 12 months. Although not included in the NDSHS, the presence or absence of use in the last three months was also assessed. Likewise, a number of questions in this survey were modified to assess the patterns of use in the last three months. Specifically, questions from the NDSHS regarding (1) frequency of use, (2) forms of cannabis used (e.g., leaf, heads, buds), (3) mode of use (e.g., joint / bong), and (4) polydrug use were measured in terms of use in the last three months, rather than 12 months as is the case with the NDSHS. This modification was made to allow the measure to be more sensitive given the time interval between each measurement occasion in the current RCT and also to allow for correspondence with the interval assessed by the Cannabis Problems Questionnaire.
The use of two types of psychostimulants were assessed: methamphetamine/ amphetamine (meth/amphetamine) and ecstasy. The use of these two types of psychostimulants were the only ones to be assessed because they are the ones most readily used by the age group of interest in the current RCT. The use of cocaine was not assessed because usage in this age group is minimal (i.e., 0.8% of 12-19 year olds report using this drug in the last 12 months) and for this reason was not a focus of the intervention program.
The Methamphetamine and Ecstasy Use Questionnaires: addressed the following areas: 1) proportion of friends and acquaintances using, (2) ever used, (3) age of initiation, (4) use in last one and 12 months, (5) frequency of use in the last 12 months and (6) presence of polydrug use in the last 12 months. An additional question assessing use in the last three months of ecstasy and methamphetamine was added to allow for direct comparison with the rates of cannabis use. All patterns of use (e.g., frequency and mode) were assessed based on 12- month use which is consistent with the NDSHS. This was done because the prevalence of use in this age group is low and a 12-month, rather than three-month interval would potentially allow sufficient numbers to detect possible intervention effects.
Timepoint [1] 302487 0
5 month follow-up
Secondary outcome [2] 302488 0
Intentions to use psychostimulants and cannabis:

Six questions were used to assess student’s intention to use cannabis, meth/ amphetamine and ecstasy in the ‘next 12 months’ and in the ‘future’. Each question required students to rate their intention on a five point likert scale labelled ‘very likely’, ‘likely’, ‘unsure’, ‘unlikely’ and ‘very unlikely’.
Timepoint [2] 302488 0
5 month follow-up

Eligibility
Key inclusion criteria
Year 10 students from Australian secondary schools.
Minimum age
13 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Members of the research team initially presented the results of the previous CLIMATE Schools: Alcohol Module trial at a number of different school area meetings for both the Catholic and Independent School systems. School staff who attended these meetings were asked to provide their names and contact details if they were interested in being involved in the development of the CLIMATE Schools: Psychostimulant and Cannabis Module. In total, staff from 30 different schools expressed an interest and all were contacted to determine their interest in being involved in the evaluation of the CLIMATE Schools: Psychostimulant and Cannabis Module. Twenty-two schools showed an interest; 21 agreed to be involved. PDHPE curriculum coordinators from each school were required to gain permission from the school executive prior to being admitted to participate in the trial. Written informed consent was obtained from each individual classroom teacher who would be participating in the trial and providing evaluation data.

It was only once all schools agreed to participate that they were then randomised to a trial group using the online program "Research Randomiser". Thereby assuring allocation concealment. Informed consent was then obtained from both parents and students to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation using an online program research randomiser
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations:
To account for cluster randomisation, sample size calculations are based on recent sample size requirements developed by Heo & Leon (Heo & Leon, 2009) to detect intervention by time interactions in longitudinal cluster randomized clinical trials. To allow for comparisons between groups, 6 schools (with at least 100 students) in each group was required, giving a total of 12 schools (with at least 1200 students). This would achieve 80% power to detect a standardized between-group mean difference of 0.15 (p = 0.05) in outcomes at the end of the trial with 3 measurement occasions. An effect size of 0.15 is comparable to previous trials of universal anxiety, depression and drug prevention programs (Teesson, Newton, & Barrett, 2012; Tobler, Roona, Ochshorn, Marshall, Streke, & Stackpole, 2000) and would have substantial benefits on a population level based on recent economic modeling (Nherera & Jacklin, 2009).

Statistical Analysis:
Attrition and differential attrition between groups was examined using a series of analysis of variance for normally distributed data, Chi-square and logistic regression for binomial and categorical data, Mann-Whitney U and Kruskal-Wallis for non-normally distributed data. To assess the effectiveness of the intervention all students with baseline data were included in the analysis irrespective of the number of program lessons they attended.
Intervention effects were examined using HLM for normally distributed outcomes measures (i.e., knowledge, expectancies). Hierarchical generalised linear modelling (HGLM) using a Poisson sampling model was used to model count data. All outcome variables were centred at post test, allowing comparison between groups immediately after the completion of the intervention. All analyses were conducted utilising the software program HLM 6. As recommended by Lee (2000), HLM / HGLM procedures were abandoned in favour of single level analyses when the unconditional hierarchical model revealed that less than 10% of systematic variance existed at the between school level. Specifically, when the variance between schools accounts for less than 10% of total variance, it is considered to be trivial and hence the intervention effects should be analysed at the individual student level. ANCOVA, logistic regression and hierarchical regression utilising SPSS were utilised for the single level analyses. In the absence of available non-parametric mixed models, Harris (1994) recommends that standard ANCOVA and hierarchical regression procedures are robust for skewed and proportional data. For each outcome variable to minimise the effects of loss to follow-up, three separate analyses were conducted to assess if there was a significant difference between the groups from baseline to each follow-up occasion. A Bonferroni adjustment was made to control the type 1 error rate (hence p<0.0167 is required for significance). For each analysis the corresponding baseline score was entered as a covariate.


References:
Heo, M., & Leon, A. C. (2009). Sample size requirements to detect an intervention by time interaction in longitudinal cluster randomized clinical trials. Statistics in Medicine, 28, 1017-1027.

Nherera, L., & Jacklin, P. (2009). A model to assess the cost-effectiveness of alcohol education developed for NICE public health guidance on personal, social, health and economic (PSHE) education. London: National Collaborating Centre for Women's and Children's Health.

Teesson, M., Newton, N. C., & Barrett, E. (2012). Australian school-based prevention programs for alcohol and other drugs: A systematic review. Drug and Alcohol Review, 31(6), 731-736.

Tobler, N. S., Roona, M. R., Ochshorn, P., Marshall, D. G., Streke, A. V., & Stackpole, K. M. (2000). School-based adolescent drug prevention programs: 1998 meta-analysis. The Journal of Primary Prevention, 20(4), 275-336.

Lee, V.E., Using hierarchical linear modeling to study social contexts: The case of school effects. Educational Psychologist, 2000. 35(2): p. 125-141.

Harris, R.J., ANOVA: An Analysis of Variance Primer, 1994. Itasca, Illinois: F.E. Peacock Publishers, Inc.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 287179 0
Government body
Name [1] 287179 0
Australian Government Department of Health and Ageing
Address [1] 287179 0
GPO Box 9848,
Canberra, ACT, 2601
Country [1] 287179 0
Australia
Funding source category [2] 287180 0
Government body
Name [2] 287180 0
Australian Research Council
Address [2] 287180 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
Country [2] 287180 0
Australia
Primary sponsor type
Individual
Name
Prof Maree Teesson
Address
National Drug and Alcohol Research Centre
University of New South Wales
22-32 King Street
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 285944 0
University
Name [1] 285944 0
University of New South Wales
Address [1] 285944 0
The University of New South Wales
High St
Kensington, NSW 2052

Country [1] 285944 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289175 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 289175 0
The University of New South Wales
High St
Kensington, NSW 2052

Ethics committee country [1] 289175 0
Australia
Date submitted for ethics approval [1] 289175 0
Approval date [1] 289175 0
19/09/2006
Ethics approval number [1] 289175 0
HREC 06252

Summary
Brief summary
The aim of the current study was to evaluate the efficacy fo the Climate Schools: Psychostimulant and Cannabis module in Australian secondary schools. It was expected that students who recieved the intervention would have increased psychostimulant and cannabis related knowledge, decreased pro-drug attitudes, decreased psychostimulant and cannabis use, and decreased intentions to use psychostimulants and cannabis, compared to students in the control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39606 0
Prof Maree Teesson
Address 39606 0
THE UNIVERSITY OF NEW SOUTH WALES
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 39606 0
Australia
Phone 39606 0
+61293850333
Fax 39606 0
Email 39606 0
m.teesson@unsw.edu.au
Contact person for public queries
Name 39607 0
Prof Maree Teesson
Address 39607 0
THE UNIVERSITY OF NEW SOUTH WALES
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 39607 0
Australia
Phone 39607 0
+61293850333
Fax 39607 0
Email 39607 0
m.teesson@unsw.edu.au
Contact person for scientific queries
Name 39608 0
Prof Maree Teesson
Address 39608 0
THE UNIVERSITY OF NEW SOUTH WALES
UNSW SYDNEY NSW 2052 AUSTRALIA
Country 39608 0
Australia
Phone 39608 0
+61293850333
Fax 39608 0
Email 39608 0
m.teesson@unsw.edu.au

No information has been provided regarding IPD availability
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