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Trial registered on ANZCTR


Registration number
ACTRN12613000708752
Ethics application status
Approved
Date submitted
25/06/2013
Date registered
28/06/2013
Date last updated
12/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The CSI (Climate Schools Interactive) Study: An evaluation of the Climate Schools Ecstasy & Emerging Drugs module in Australian secondary schools
Scientific title
The CSI Study: An evaluation of an online program to prevent the use of ecstasy and new psychoactive substances among Australian adolescents
Secondary ID [1] 282737 0
nil
Universal Trial Number (UTN)
U1111-1144-8622
Trial acronym
The CSI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use prevention 289471 0
Prevention of substance use-related harms 289472 0
Condition category
Condition code
Mental Health 289784 289784 0 0
Addiction
Public Health 289785 289785 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating secondary schools will be randomly allocated to one of two groups. One group will serve as the control group and receive their usual drug education in school and the other group with receive the Climate Schools intervention: Climate Schools Intervention The Climate Schools: Ecstasy & Emerging Drugs Module is an online school-based prevention program designed to prevent the use of ecstasy and New and Emerging Drugs (NEDs) and reduce related harms. The intervention consists of four 40-minute lessons delivered as part of the Year 10 PDHPE syllabus. The lessons are intended to be delivered once weekly over a four week period. The first part of each lesson is completed individually over the internet where students view a 15-20 minute cartoon storyline. The second part of each lesson consists of online and group activities designed to reinforce the information in the cartoons and foster interactive communication between students. Teachers are provided with a manual containing the activities, implementation guidelines, links to the education syllabus and summaries for each lesson. To monitor adherence to the intervention, teachers are required to complete an online Fidelity Logbook. The logbooks ask teachers to indicate which lessons and activities they completed with their class and to write down any adaptions they made to the program. To ensure completion of the online component of the intervention, students are required to view the cartoon lesson in full before being granted access the following lesson.
Intervention code [1] 287398 0
Prevention
Comparator / control treatment
The Climate Schools intervention will be compared to a “standard treatment’ control group. Students in the control group will receive their usual Year 10 PDHPE lessons at school, which includes drug and alcohol education, delivered by their teacher.
Control group
Active

Outcomes
Primary outcome [1] 289867 0
Intentions to use ecstasy. Students rated how likely they were to use ecstasy during the next 6 months and responses were coded ‘very unlikely, unlikely, unsure = 0’ or ‘likely, very likely = 1’.
Timepoint [1] 289867 0
Measured at baseline, and at 1, 6, 12 and 24-months post intervention.

The primary timepoint is 12-months.
Primary outcome [2] 289868 0
Intentions to use any NPS. Students rated how likely they were to use any type of NPS during the next 6 months and responses were coded ‘very unlikely, unlikely, unsure = 0’ or ‘likely, very likely = 1’.
Timepoint [2] 289868 0
Baseline, and at 1, 6, 12 and 24-months post intervention.
Secondary outcome [1] 303425 0
Life-time ecstasy use was assessed via a single item (‘Have you ever used ecstasy?; yes/no), adapted from the 2010 Australian National Drug Strategy Household Survey. Three similar items were used to assess lifetime use of ‘any NPS’, ‘synthetic cannabis (marijuana), e.g. Spice, Kronic, K2’ and ‘synthetic stimulants (‘bath salts’). The distinction between synthetic cannabis and synthetic stimulants (cathinones) is consistent with the Monitoring the Future survey from the United States.
Timepoint [1] 303425 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [2] 348026 0
Knowledge about ecstasy. Ecstasy knowledge was assessed using a 15-item scale developed to reflect the intended content of the Climate Schools intervention. Items assessed knowledge about the prevalence of use, risks and harm-minimization information. For each statements, students were required to answer ‘True’, ‘False’ or ‘Don’t Know. Scores were summed to produce a total knowledge score.
Timepoint [2] 348026 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [3] 348027 0
Knowledge about NPS. Knowledge about NPS was assessed using five items measuring students’ knowledge about NPS themselves, the associated harms and prevalence of use. For each statement, students were required to answer ‘True’, ‘False’ or ‘Don’t Know. Scores were summed to produce a total knowledge score.
Timepoint [3] 348027 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [4] 348028 0
Intentions to use synthetic cannabis. Students were asked to rate how likely they are to use synthetic cannabis in the ‘next six months’ and ‘at any time in the future’. Each item required students to rate their intention on a five-point Likert scale labelled ‘very likely’ to ‘very unlikely’. responses were coded ‘very unlikely, unlikely, unsure = 0’ or ‘likely, very likely = 1’.
Timepoint [4] 348028 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [5] 348029 0
Intentions to use synthetic stimulants ('bath salts'). Students were asked to rate how likely they are to use synthetic stimulants in the ‘next six months’ and ‘at any time in the future’. Each item required students to rate their intention on a five-point Likert scale labelled ‘very likely’ to ‘very unlikely’. responses were coded ‘very unlikely, unlikely, unsure = 0’ or ‘likely, very likely = 1’.
Timepoint [5] 348029 0
Baseline, and at 1, 6, 12 and 24-months post intervention

Eligibility
Key inclusion criteria
Year 10 students at participating Sydney schools
Minimum age
15 Years
Maximum age
18 Years
Sex
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)
Schools will be randomised to one of the two study groups using the online program Research Randomizer. Allocation will be concealed via central randomisation using computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomised to one of the four study groups using the online program Research Randomizer (simple randomisation using computer software).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline equivalence between the groups was examined using chi-squared tests and Fisher’s exact tests for categorical outcomes and one-way analysis of variance (ANOVA) for continuous outcomes. To analyse the primary outcomes, multi-level logistic regressions including fixed and random effects were estimated in Stata version 13. Specification of random effects in these models take into account variation at the individual level, and clustering or potential lack of independence in data from students within the same school. Multi-level logistic regressions (using the xtmelogit command) were also conducted for secondary binary outcomes (life-time use and intentions), and multi-level linear regression models (using the xtmixed command) examined intervention effects over time on secondary continuous outcomes (knowledge). All models included a random intercept and preliminary models were estimated to determine the most appropriate covariance structure and optimal number of integration points to specify for each logistic regression. A three-level regression model was estimated for each outcome, with repeated observations (level 1) nested within students (level 2) and students clustered within schools (level 3). For each outcome, the model included a variable representing the trial group (intervention = 0, control = 1), time (coded categorically from 0 to 3), gender, and baseline academic grades. The intervention effect was assessed with the trial group × time interaction. Gender was included as a covariate in all analyses to adjust for differences between the groups at baseline. Academic grades were included as a covariate in light of evidence that indicates that poor academic achievement is associated with greater substance use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
16/09/2013
Date of last participant enrolment
Anticipated
27/01/2014
Actual
13/11/2013
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
900
Accrual to date
Final
1126
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287510 0
Government body
Name [1] 287510 0
National Health and Medical Research Council
Country [1] 287510 0
Australia
Funding source category [2] 287511 0
Government body
Name [2] 287511 0
Australian Government Department of Health and Aging
Country [2] 287511 0
Australia
Primary sponsor type
Individual
Name
Dr Nicola Newton
Address
National Drug and Alcohol Research Centre (NDARC)
University of New South Wales
Sydney, NSW, 2052
Country
Australia
Secondary sponsor category [1] 286251 0
University
Name [1] 286251 0
University of New South Wales
Address [1] 286251 0
The University of New South Wales
High St
Kensington, NSW 2052
Country [1] 286251 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289484 0
University of New South Wales HREC
Ethics committee address [1] 289484 0
Ethics committee country [1] 289484 0
Australia
Date submitted for ethics approval [1] 289484 0
Approval date [1] 289484 0
09/05/2013
Ethics approval number [1] 289484 0
HC13075

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41050 0
Miss Katrina Champion
Address 41050 0
National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
Country 41050 0
Australia
Phone 41050 0
+612 9385 0175
Fax 41050 0
+612 9385 0222
Email 41050 0
k.champion@unsw.edu.au
Contact person for public queries
Name 41051 0
Katrina Champion
Address 41051 0
National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
Country 41051 0
Australia
Phone 41051 0
+612 9385 0175
Fax 41051 0
+612 9385 0222
Email 41051 0
k.champion@unsw.edu.au
Contact person for scientific queries
Name 41052 0
Katrina Champion
Address 41052 0
National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
Country 41052 0
Australia
Phone 41052 0
+612 9385 0175
Fax 41052 0
+612 9385 0222
Email 41052 0
k.champion@unsw.edu.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
EmbaseCluster randomised controlled trial of an online intervention to prevent ecstasy and new psychoactive substance use among adolescents: Final results and implications for implementation.2018https://dx.doi.org/10.1136/bmjopen-2017-020433
N.B. These documents automatically identified may not have been verified by the study sponsor.