Trial registered on ANZCTR


Trial ID
ACTRN12613000708752
Ethics application status
Approved
Date submitted
25/06/2013
Date registered
28/06/2013
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

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
Frequency of ecstasy and NPS 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”
Timepoint [1] 289867 0
Baseline, and at 1, 6, 12 and 24-months post intervention.
Primary outcome [2] 289868 0
Intentions to use ecstasy and NPS.. Intentions to use ecstasy, synthetic cannabis, synthetic stimulants (‘bath salts’) and NPS 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’.
Timepoint [2] 289868 0
Baseline, and at 1, 6, 12 and 24-months post intervention.
Primary outcome [3] 289869 0
Knowledge about ecstasy and NPS 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 NPS 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.
Timepoint [3] 289869 0
Baseline, and at 1, 6, 12 and 24-months post intervention.
Secondary outcome [1] 303425 0
Patterns of ecstasy and NPS 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.
Timepoint [1] 303425 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [2] 303426 0
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’.
Timepoint [2] 303426 0
At baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [3] 303427 0
Beliefs about the consequences of ecstasy and NPS use will be measured using items adapted from the Project ALERT questionnaire. To elicit perceptions about the social consequences of using ecstasy and NPS, 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’.
Timepoint [3] 303427 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [4] 303429 0
Psychological distress, as measured by the Kessler 6 scale, a 6-item scale that measures depressive and anxiety symptoms in the past 4 weeks.
Timepoint [4] 303429 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [5] 303430 0
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”.
Timepoint [5] 303430 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [6] 303431 0
Strengths and difficulties, as assessed by the 25-item Strengths and Difficulties Questionnaire (SDQ) (Goodman et al., 1998).
Timepoint [6] 303431 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [7] 303433 0
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).
Timepoint [7] 303433 0
Baseline, and at 1, 6, 12 and 24-months post intervention
Secondary outcome [8] 303436 0
Normative Beliefs and Perceptions about Ecstasy and NPS use. To measure normative beliefs, students will be asked to estimate the proportion of their peers that use ecstasy and NPS. Participants will also be asked three items adapted from the Project ALERT questionnaire, which aim to measure peer tolerance about ecstasy and NPS 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 NPS..
Timepoint [8] 303436 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
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)
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

Recruitment
Anticipated date of first participant enrolment
2/09/2013
Actual date of first participant enrolment
16/09/2013
Anticipated date last participant enrolled
27/01/2014
Actual date last participant enrolled
13/11/2015
Target sample size
900
Actual sample size
1126
Recruitment status
Closed: follow-up continuing
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
Address [1] 287510 0
GPO Box 1421
Canberra ACT 2601
Country [1] 287510 0
Australia
Funding source category [2] 287511 0
Government body
Name [2] 287511 0
Australian Government Department of Health and Aging
Address [2] 287511 0
GPO Box 9848,
Canberra ACT 2601, Australia
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
UNIVERSITY OF NSW
Sydney, NSW, 2052
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
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.
Trial website
www.csistudy.org.au
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
Miss 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
Miss 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