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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
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Scientific title
The CSI Study: An evaluation of an online program to prevent the use of ecstasy and new psychoactive substances among Australian adolescents
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Secondary ID [1]
282737
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nil
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Universal Trial Number (UTN)
U1111-1144-8622
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Trial acronym
The CSI Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Substance use prevention
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Prevention of substance use-related harms
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Condition category
Condition code
Mental Health
289784
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0
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Addiction
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Public Health
289785
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287398
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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’.
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Assessment method [1]
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Timepoint [1]
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Measured at baseline, and at 1, 6, 12 and 24-months post intervention.
The primary timepoint is 12-months.
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Primary outcome [2]
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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’.
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Assessment method [2]
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Timepoint [2]
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Baseline, and at 1, 6, 12 and 24-months post intervention.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline, and at 1, 6, 12 and 24-months post intervention
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Secondary outcome [2]
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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.
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Assessment method [2]
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Timepoint [2]
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Baseline, and at 1, 6, 12 and 24-months post intervention
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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Baseline, and at 1, 6, 12 and 24-months post intervention
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Secondary outcome [4]
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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’.
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Assessment method [4]
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Timepoint [4]
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Baseline, and at 1, 6, 12 and 24-months post intervention
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Secondary outcome [5]
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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’.
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Assessment method [5]
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Timepoint [5]
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Baseline, and at 1, 6, 12 and 24-months post intervention
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Eligibility
Key inclusion criteria
Year 10 students at participating Sydney schools
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Minimum age
15
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
nil
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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)
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.
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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).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
nil
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/09/2013
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Actual
16/09/2013
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Date of last participant enrolment
Anticipated
27/01/2014
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Actual
13/11/2013
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Date of last data collection
Anticipated
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Actual
31/03/2016
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Sample size
Target
900
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Accrual to date
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Final
1126
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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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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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GPO Box 1421
Canberra ACT 2601
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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 Government Department of Health and Aging
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Address [2]
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GPO Box 9848,
Canberra ACT 2601, Australia
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Dr Nicola Newton
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Address
National Drug and Alcohol Research Centre (NDARC)
University of New South Wales
Sydney, NSW, 2052
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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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University of New South Wales
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Address [1]
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The University of New South Wales
High St
Kensington, NSW 2052
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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 HREC
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Ethics committee address [1]
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UNIVERSITY OF NSW
Sydney, NSW, 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
289484
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Approval date [1]
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09/05/2013
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Ethics approval number [1]
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HC13075
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Summary
Brief summary
The aim of the CSI (Climate Schools Interactive) Study is to evaluate the Climate Schools: Ecstasy & Emerging Drugs module, an online, school-based prevention program designed to educate adolescents about the harms associated with illicit drug use. To our knowledge, this will be the first trial of any internet-based program specifically designed to prevent the uptake and use of ecstasy and NPS. It is hypothesized that students receiving the Climate Schools intervention will report reduced ecstasy and NPS use, reduced intentions to use ecstasy and NPS in the future, increased knowledge about these drugs and reduced associated harms.
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Trial website
www.csistudy.org.au
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Miss Katrina Champion
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Address
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National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
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Country
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Australia
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Phone
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+612 9385 0175
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Fax
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+612 9385 0222
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Email
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[email protected]
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Contact person for public queries
Name
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Miss Katrina Champion
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Address
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National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
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Country
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Australia
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Phone
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+612 9385 0175
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Fax
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+612 9385 0222
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Email
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[email protected]
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Contact person for scientific queries
Name
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Miss Katrina Champion
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Address
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National Drug and Alcohol Research Centre
University of NSW
Sydney, NSW 2052
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Country
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Australia
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Phone
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+612 9385 0175
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Fax
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+612 9385 0222
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Cluster randomised controlled trial of an online intervention to prevent ecstasy and new psychoactive substance use among adolescents: Final results and implications for implementation.
2018
https://dx.doi.org/10.1136/bmjopen-2017-020433
N.B. These documents automatically identified may not have been verified by the study sponsor.
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