Trial from ANZCTR


Trial ID ACTRN12613000708752
Trial Status: Registered
Date Submitted: 25/06/2013
Date Registered: 28/06/2013
Prospectively registered

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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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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The CSI Study: An evaluation of an online program to prevent the use of ecstasy and new and emerging drugs among Australian adolescents
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Secondary ID [1] 282737 0
nil
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UTN U1111-1144-8622
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Trial acronym The CSI Study
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Health condition(s) or problem(s) studied:
Substance use prevention 289471 0
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Prevention of substance use-related harms 289472 0
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Condition category: Condition code:
Mental Health Addiction
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289784 289784 0 0
Public Health Health promotion/education
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289785 289785 0 0

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Descriptions 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:
Prevention 287398 0
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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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Primary Outcome: Frequency of ecstasy and NED use. Frequency of use is measured using three items which assess how often students have used ecstasy, synthetic cannabis or a synthetic stimulant ('bath salts') in the past 6 months. Responses are made on a 6-point scale labelled “Never”, “Less than monthly”, “Once a month”, “2-3 times a month”, “weekly” and “Daily or almost daily”. 289867 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention. 289867 0
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Primary Outcome: Intentions to use ecstasy and NEDs. Intentions to use ecstasy, synthetic cannabis, synthetic stimulants (‘bath salts’) and NEDs in general will be assessed using eight items. Students will be asked to rate how likely they are to use each of these substances in the ‘next six months’ and ‘at any time in the future’. Each item requires students to rate their intention on a five-point Likert scale labelled ‘very likely’ to ‘very unlikely’. 289868 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention. 289868 0
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Primary Outcome: Knowledge about ecstasy and NEDs is assessed using a 20-item scale specifically developed to reflect the intended content of the Climate Schools intervention. Items cover knowledge of ecstasy and NEDs in relation to the drugs themselves, prevalence of use, physical and mental health, legal consequences and information to minimise the harm associated with their use. For each of the 20 statements, students are required to answer ‘True’, ‘False’ or ‘Don’t Know. 289869 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention. 289869 0
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Secondary Outcome: Patterns of ecstasy and NED use are assessed using questions adapted from the 2010 NDSHS. Students will be asked if they have ever used ecstasy or an emerging drug (either synthetic cannabis or synthetic stimulants/‘bath salts’), the age of first use, use in the past six months, use in the past month as well as the quantity of use. 303425 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303425 0
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Secondary Outcome: Students will be asked to rate the frequency and quantity of their alcohol use in the past six months and the frequency of drinking to excess (consuming five or more standard drinks on one occasion). Other substance use will be measured using four items that ask whether students have tried tobacco, cannabis, methamphetamine/amphetamine or any other substance in the past six months. Possible responses are ‘never’, ‘tried once’, ‘tried more than once and less than five times’ or ‘tried five times or more’. 303426 0
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Timepoint: At baseline, and at 1, 6, 12 and 24-months post intervention 303426 0
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Secondary Outcome: Beliefs about the consequences of ecstasy and NED use will be measured using items adapted from the Project ALERT questionnaire. To elicit perceptions about the social consequences of using ecstasy and NEDs, students will be asked about the positive and negative expectancies of using these drugs, for example, ‘using ecstasy and emerging drugs makes you feel more confident’. Responses will be made on a four-point Likert scale labelled ‘strongly agree’, ‘sort of agree’, ‘sort of disagree’ and ‘strongly disagree’. 303427 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303427 0
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Secondary Outcome: Psychological distress, as measured by the Kessler 6 scale, a 6-item scale that measures depressive and anxiety symptoms in the past 4 weeks. 303429 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303429 0
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Secondary Outcome: Peer Pressure, as assessed by Bandura’s 9-item Resistive Self-regulatory Efficacy scale. This scale consists of 9 items that ask students to rate how well they can resist peer pressure to engage in nine different behaviours e.g. “How well can you resist peer pressure to use pills (ecstasy)”. Responses are made on a 7-point scale ranging from “Not well at all” to “Very Well”. 303430 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303430 0
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Secondary Outcome: Strengths and difficulties, as assessed by the 25-item Strengths and Difficulties Questionnaire (SDQ) (Goodman et al., 1998). 303431 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303431 0
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Secondary Outcome: Information about Peers and Parents.

Two items will be combined to provide an indicator of general parental monitoring (Svensson, 2003). Peer Deviance will be assessed using five items (Svensson, 2003) which ask whether the student has a friend who engages in deviant behaviour e.g. 'do you have a friend who has stolen something from a store?' (Yes/No).
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303433 0
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Secondary Outcome: Normative Beliefs and Perceptions about Ecstasy and NED use. To measure normative beliefs, students will be asked to estimate the proportion of their peers that use ecstasy and NEDs. Participants will also be asked three items adapted from the Project ALERT questionnaire, which aim to measure peer tolerance about ecstasy and NED use. For example, students will be asked to anticipate their friends' reactions if they ‘found out you used ecstasy or emerging drugs sometimes’ (1= ‘they would disapprove and stop being my friends’ to 4= ‘they would approve’). Students will also be asked to indicate how strongly they agree or disagree with three statements relating to perceptions of the legality and safety of NEDs. 303436 0
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Timepoint: Baseline, and at 1, 6, 12 and 24-months post intervention 303436 0
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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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Gender Both males and females
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Healthy volunteers? Yes
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Key exclusion criteria nil
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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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Describe the 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 (choose all that apply) The people receiving the treatment/s

The people assessing the outcomes
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Assignment Parallel
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Other design features nil
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis Sample size:
Cluster randomisation has been employed in this study to avoid contamination of the control group by the intervention group through student communication (Kerry & Bland, 1998). To account for cluster randomisation, sample size calculations are based on recent sample size requirements developed by Heo & Leon (2009) to detect intervention by time interactions in longitudinal cluster randomized clinical trials. To detect differences between groups, 5 schools (with at least 75 students each) will be randomly allocated to receive the Climate Schools intervention, and 5 schools (with at least 75 students each) to a control group. Based on a recent school-based trial conducted by the investigators, in which there was an average of 125 students per grade in Sydney secondary schools, recruiting 75 students per school is feasible. This would achieve 80% power to detect a standardized between-group mean difference of 0.20 (p =0.05) in outcomes at the end of the trial with three measurement occasions. An effect size of 0.20 is comparable to previous trials of universal drug prevention programs (Cuijpers, 2002; Vogl et al., 2009). To account for school dropouts during the trial which we expect to be approximately 10% (Newton et al., 2009), we aim to recruit at least 12 schools (6 for the Climate Intervention, 6 for the Control group). This will give us a minimum of 900 students at baseline to test the effect of the intervention in the overall group.

Statistical Analyses:
Baseline equivalence and attrition between groups will be examined using single-level analyses; one-way analyses of variance to examine normally distributed data, Chi-square to examine binominal data, and Mann-Whitney U-test to examine non-normally distributed data. To examine intervention by time interaction effects, mixed effects regression will be used due to the multi-level and hierarchical nature of the data. To account for intracluster correlations between schools, intervention effects will primarily be examined using multi-level modelling for normally distributed data and hierarchical generalized linear modelling using Poisson sampling for count data. Outcome variables will be centred at post-test to allow for comparisons between groups immediately after the intervention and growth terms will be analysed to determine the magnitude of the follow-up effects. Analyses will be conducted using the program HLM 6. If unconditional models reveal that less than 10% of systematic variance exists at the between-school level for any outcome variable, HLM will be abandoned and single-level analyses will be used. For these variables, ANCOVAs utilising the SPSS GLM procedure will be conducted to account for any baseline differences that might exist between groups. Bonferroni adjustments will be made for multiple comparisons. Odds ratios and 95% confidence intervals will also be calculated.
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Phase Not Applicable
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Anticipated date of first participant enrolment 2/09/2013
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Date of first participant enrolment 16/09/2013
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Anticipated date last participant recruited/enrolled 27/01/2014
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Actual date last participant recruited/enrolled
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Target sample size 900
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s) NSW
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Recruitment outside Australia

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Funding Source: Government body 287510 0
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Name: National Health and Medical Research Council 287510 0
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Address: GPO Box 1421
Canberra ACT 2601
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Country: Australia 287510 0
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Funding Source: Government body 287511 0
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Name: Australian Government Department of Health and Aging 287511 0
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Address: GPO Box 9848,
Canberra ACT 2601, Australia
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Country: Australia 287511 0
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Primary Sponsor 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: University 286251 0
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Name: University of New South Wales 286251 0
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Address: The University of New South Wales
High St
Kensington, NSW 2052
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Country: Australia 286251 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of New South Wales HREC 289484 0
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Address: UNIVERSITY OF NSW
Sydney, NSW, 2052
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Country: Australia 289484 0
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Approval Date: 09/05/2013 289484 0
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Submitted Date: 289484 0
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HREC: HC13075 289484 0
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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 EPS. It is hypothesized that students receiving the Climate Schools intervention will report reduced ecstasy and EPS use, reduced intentions to use ecstasy and EPS 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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Principal Investigator
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Name: Katrina Champion
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Address: National Drug and Alcohol Research Centre University of NSW Sydney, NSW 2052
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Country: Australia
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Tel: +612 9385 0175
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Fax: +612 9385 0222
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Email: k.champion@unsw.edu.au
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Contact person for public queries
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Name: Katrina Champion
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Address: National Drug and Alcohol Research Centre University of NSW Sydney, NSW 2052
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Contact person for scientific queries
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Name: Katrina Champion
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Address: National Drug and Alcohol Research Centre University of NSW Sydney, NSW 2052
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Email: k.champion@unsw.edu.au
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Contact person responsible for updating information
Title: Miss
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Name: Katrina Champion
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Address: National Drug and Alcohol Research Centre University of NSW Sydney, NSW 2052
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Country: Australia
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Tel: +612 9385 0175
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Addition Cancer fields
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