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Trial registered on ANZCTR


Registration number
ACTRN12618000153213
Ethics application status
Approved
Date submitted
15/12/2017
Date registered
1/02/2018
Date last updated
5/10/2021
Date data sharing statement initially provided
1/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Climate Schools Plus Study: Evaluating an online, combined student-parent substance use prevention program
Scientific title
The Climate Schools Plus (CSP) intervention: An online, combined student-parent substance use program to prevent substance use and related harms in Australian adolescents, aged 13 to 16 years.
Secondary ID [1] 293619 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
CSP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance use prevention 305887 0
Prevention of substance use related harms 305888 0
Condition category
Condition code
Mental Health 305081 305081 0 0
Addiction
Public Health 305082 305082 0 0
Health promotion/education
Public Health 305083 305083 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating secondary schools will be randomly allocated to one of two groups.

Group 1:
The Control condition: One group will serve as the control group and receive their usual Personal Development, Health and Physical Education (PDHPE) classes, including alcohol education.

Group 2:
The Climate Schools Plus condition: One group will serve as the intervention group and receive the Climate Schools Plus intervention, which aims to reduce the use of Australia’s most commonly used licit and illicit drugs: alcohol and cannabis and prevent related harms. The program consists of the 6 x 40 minute lessons in Year 8 (with a focus on alcohol and its related harms) and 6 x 40 minute lessons in year 9 (with a focus on alcohol and cannabis related harms), which students will receive during their regularly scheduled PDHPE classes once per week in year 8 and once per week in year 9. The modules will be administered primarily online, in which students will register for the program on the Climate Schools Plus website and access approx. 20 minute cartoons which follow a group of teenagers who are their own age as they learn about substance use and its related harms. The remainder of each lesson will involve completing set class activities (e.g., developing a mind map about the long-term consequences of drinking to excess), which will be chosen from a set list of activities and administered by their regular PDHPE teachers (consistent with the format of the Climate Schools program). During the same time, the parents of these students will be able to freely access the Climate Schools Plus website and will be invited to watch a brief 7-minute webinar to introduce them to the important themes of the program. They will also be invited to rank school rules regarding alcohol supply and monitoring and explore modules containing similar content to the Climate Schools lessons that their child receives in class. The time commitment asked of parents is variable, depending on how greatly they choose to engage with the program over the school term. The minimum requirement is for parents to register and complete a baseline questionnaire regarding their knowledge and attitudes towards alcohol and other drugs, which is estimated to take no longer than 45 minutes to complete. The webinar component is brief and lasts approximately 7 minutes, similarly, the rule ranking should take less than one minute. Each parent module is also brief and designed to take no longer than 20 minutes to complete (4 x 20 minute modules in year 8 and 2 x 20 minute modules in year 9). These 6 modules cover the following topics:
• Module 1: Prevalence, patterns and harms of adolescent alcohol use
o This module provides key facts about alcohol, including harms and consequences of use among adolescents, as well as addressing common myths about alcohol use.
• Module 2: Parental attitudes and rule-setting
o This module provides information about the important role parents play in preventing alcohol use and related harms in their adolescent. It also provides practical tips for monitoring their child's alcohol use and setting rules around alcohol use
• Module 3: Parental supply and use
o This module addresses parental supply of alcohol to adolescents. It discusses the latest research as well as current legislation, and aims to dispel common myths. It also considers the effect of a parents' own drinking on their adolescent’s drinking.
• Module 4: Communication and involvement
o This module will provide practical tips for effective communication, as well as strategies for parents to stay involved in their child's life. The tips for communication are designed to help parents talk with their child about alcohol, but will also be helpful for communication in general.
• Module 5: Getting the Facts about Cannabis
o This module covers the basics of cannabis: what it is, how it is used and what its effects are. It also looks at the prevalence and harms of adolescent cannabis use
• Module 6: What parents can do to prevent adolescent cannabis use
o This module first covers how to recognize signs of cannabis use in young people and looks at some parenting factors that have been shown to reduce the likelihood of adolescents using cannabis.

Online tracking will be used to monitor the extent to which participants engage with the intervention (i.e., tracking the number of webinar views, the number of participants that ranked the rules and the number of participants that completed each module etc.). Participants will also be invited to complete an evaluation of the program (1 x 30 minutes in year 8 and 1 x 30 minutes in year 9), which seeks feedback on the look and feel of the program itself and the usefulness of the information provided.
Intervention code [1] 299877 0
Prevention
Intervention code [2] 299878 0
Lifestyle
Intervention code [3] 299879 0
Behaviour
Comparator / control treatment
The Climate Schools Plus (CSP) Intervention will be compared to:
A "standard treatment" control group – Students/Parents will not receive the Climate Schools Plus intervention. Participants will instead complete their standard Year 8 and Year 9 Personal Development, Health and Physical Education classes, delivered by their teacher as usual. The parents will be part of a wait-list control condition, in which they will have no access to the program for the duration of the study, but will be offered access to the parent part of the program at the conclusion of the study (i.e., 24 months after baseline).
Control group
Active

Outcomes
Primary outcome [1] 304259 0
Any student alcohol use (student reported)
At each time point, students will be asked if they have had a full serve of alcohol (any drinking) with the primary endpoint being 24 months. These questions were originally adapted from the School Health and Alcohol Harm Reduction Project (SHAHRP) ‘Patterns of Alcohol’ index and trials of the Preventure program, and reflect those used in previous Climate Schools trials.
Timepoint [1] 304259 0
Assessed at baseline and at 12, and 24 months (primary endpoint), after study commencement.
Primary outcome [2] 304611 0
Any student drinking to excess (5+ drinks on a single occasion; student reported)
At each time point, students will be asked if they have drunk to excess, with the primary endpoint being 24 months. These questions were originally adapted from the School Health and Alcohol Harm Reduction Project (SHAHRP) ‘Patterns of Alcohol’ index and trials of the Preventure program, and reflect those used in previous Climate Schools trials.
Timepoint [2] 304611 0
Assessed at baseline and at 12, and 24 months (primary endpoint), after study commencement.
Secondary outcome [1] 341386 0
Student alcohol use related harms (student reported)
Alcohol related harms will be assessed using the 23-item Rutgers Alcohol Problem Index (RAPI).
Timepoint [1] 341386 0
Assessed at baseline and at 12, and 24 months after study commencement.
Secondary outcome [2] 341387 0
Parental supply (student and parent reported)

2-question scale from the Australian Parental Supply of Alcohol Longitudinal study (APSAL; Aiken et al., 2015) will examine the frequency and quantity of alcohol supplied by parents. Both students and parents will be asked to report.
Timepoint [2] 341387 0
Assessed at baseline and at 12, and 24 months after study commencement.
Secondary outcome [3] 341388 0
Student Use of cannabis (student reported)

Cannabis and other drug use will be measured by questions based on the National Drug Strategy Household Survey (NDSHS), 2016, and the Australian Secondary Students Alcohol and Drug Survey (ASSAD), 2014. This allows for comparison between use in the current sample and a large scale representative group of Australians.
Timepoint [3] 341388 0
Assessed at 12 and 24 months after study commencement.
Secondary outcome [4] 341389 0
Parent-adolescent communication (student and parent reported)

The Parent-Adolescent Communication Scale (Olson, 1985) is 20-item scale which measures how cohesive and adaptable communication is between parents and children
Timepoint [4] 341389 0
Assessed at baseline and at 12, and 24 months after study commencement.
Secondary outcome [5] 341390 0
Alcohol related Knowledge (student and parent reported)

Alcohol related knowledge will be assessed using a questionnaire originally adapted from the SHAHRP 16-item ‘Knowledge of Alcohol’ index, and as used in previous trials using the Climate Schools programs.
Timepoint [5] 341390 0
Assessed at baseline and at 12, and 24 months after study commencement.
Secondary outcome [6] 341391 0
Cannabis related Knowledge (student and parent reported)

Participants’ knowledge about cannabis will be assessed by 16 items from the ‘Knowledge about Cannabis’ scale used in previous Climate Schools trials.
Timepoint [6] 341391 0
Assessed at 12 and 24 months after study commencement
Secondary outcome [7] 342337 0
Frequency of alcohol consumption (student reported)
At each time point, students will be asked to report the frequency of their alcohol consumption measured in standard drinks. These questions were originally adapted from the School Health and Alcohol Harm Reduction Project (SHAHRP) ‘Patterns of Alcohol’ index and trials of the Preventure program, and reflect those used in previous Climate Schools trials.
Timepoint [7] 342337 0
Assessed at baseline, 12 and 24 months after study commencement
Secondary outcome [8] 342338 0
Frequency of drinking to excess (student reported)
At each time point, students will be asked to report the frequency of drinking to excess (defined as having more than 5 standard drinks on a single occasion). These questions were originally adapted from the School Health and Alcohol Harm Reduction Project (SHAHRP) ‘Patterns of Alcohol’ index and trials of the Preventure program, and reflect those used in previous Climate Schools trials.
Timepoint [8] 342338 0
Assessed at baseline, 12 and 24 months after study commencement.
Secondary outcome [9] 348392 0
Parental self-efficacy (parent reported) A 3-item scale measuring parents’ confidence in their ability to prevent their adolescent from drinking alcohol (Van der Vorst et al., 2005), which has been used and validated in Preventing heavy alcohol use in adolescents (PAS) studies (e.g. Koning et al., 2015).
Timepoint [9] 348392 0
Assessed at baseline, 12- and 24-months after study commencement.

Eligibility
Key inclusion criteria
All students (both male and female) in Year 8 of Secondary School at the beginning of the trial in 2018 (approx. 13-14years of age).
Parent participants will include the parents/guardians of the participating students.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-consenters – parental and student

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 randomly allocated to intervention or control groups by an external researcher using the Ralloc function in the Stata statistical software program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be randomly allocated to intervention or control using stratified random allocation. Schools will be divided into three mutually exclusive strata:
1. Mixed boys and girls school
2. Single sex or predominately girls school
3. Single sex or predominately boys school
Allocation will be random within strata to achieve balance across intervention and control groups in number of males and females participating in the trial. Randomisation will be achieved using a randomisation table created in StataSE, version 14 using the statarand procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size:
To account for cluster randomisation, sample size calculations are based on sample size requirements developed by Heo & Leon (2009) to detect intervention by time interactions in longitudinal cluster randomized clinical trials. This trial will be powered to detect differences in the overall sample across three time points. 5 schools per group (with at least 70 students per school) are required per intervention group. This would achieve 80% power to detect a standardized between-group mean difference of 0.2 (p = 0.05) in outcomes at the end of the trial with 3 measurement occasions. An effect size of 0.2 is comparable to previous trials of combined student and parent programs (ES ranged 0.2-0.3; Newton et al., 2016), and this effect size would, as anticipated/hypothesised, be an improvement from those reported in the Climate Schools student-alone studies (0.18 for Climate Schools: Alcohol and Cannabis, Newton et al., 2012). To account for school dropouts during the trial, which we expect to be approximately 15%, we aim to recruit at least 12 schools in total. This will give us a total of 840 students from 12 schools at baseline to test the effect of the intervention. As both parents of each year 8 child will be encouraged to participate in the trial, the number of parent participants will range from 840-1680 at baseline.

Statistical Analysis:
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.
Primary and secondary outcomes will be analysed in longitudinal analyses using multilevel mixed effects regression models. The effects of greatest interest are Intervention × Time interactions that reflect differences between intervention groups in the growth of each outcome over time. Multilevel modelling can account for the expected correlations between different observations of the same individual and between individuals in the same school, which would otherwise violate assumptions of independence in traditional regression models. Therefore, models used in these analyses will incorporate both random intercepts and slopes for time at the individual level, and random intercepts at the school level. Mixed effects regression approaches that use maximum likelihood estimation are superior to alternative missing data strategies such as pairwise deletion. Maximum likelihood methods produce unbiased estimates when missing data is assumed to be either missing completely at random (MCAR) or missing at random (MAR). Generalised linear modelling approaches will be applied where appropriate, so that logistic regression with a logit link function will be applied when analysing binary outcomes. To determine the best fitting model for each outcome, possible fixed effects and random effects structures will be compared using likelihood ratio tests and model fit statistics such as the Akaike information criterion. For all outcomes, measures of effect size such as standardized mean differences (e.g. Cohen’s d) and odds ratios will be calculated along with their corresponding 95% confidence intervals to provide interpretable estimates of the intervention effects. All analyses will be carried out on an intention-to-treat basis, retaining and analysing all participants in the intervention groups they were originally allocated to.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/01/2018
Date of last participant enrolment
Anticipated
31/10/2019
Actual
31/10/2019
Date of last data collection
Anticipated
16/12/2020
Actual
22/01/2021
Sample size
Target
840
Accrual to date
Final
562
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 298231 0
Government body
Name [1] 298231 0
Australian Government Department of Health
Country [1] 298231 0
Australia
Funding source category [2] 298233 0
Charities/Societies/Foundations
Name [2] 298233 0
Society for Mental Health Research
Country [2] 298233 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nicola Newton
Address
The Matilda Centre
Lvl 6 Jane Foss Russell Building
University of Sydney
Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 297349 0
University
Name [1] 297349 0
University of Sydney
Address [1] 297349 0
University of Sydney, Sydney NSW 2006
Country [1] 297349 0
Australia
Other collaborator category [1] 279868 0
University
Name [1] 279868 0
NDRI, Curtin University
Address [1] 279868 0
10 Selby Street
Shenton Park WA 6008
Country [1] 279868 0
Australia
Other collaborator category [2] 279869 0
University
Name [2] 279869 0
Utrecht University
Address [2] 279869 0
Domplein 29, 3512 JE Utrecht, Netherlands
Country [2] 279869 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299240 0
University of New South Wales, Human Research Ethics Committee
Ethics committee address [1] 299240 0
Ethics committee country [1] 299240 0
Australia
Date submitted for ethics approval [1] 299240 0
27/09/2017
Approval date [1] 299240 0
27/10/2017
Ethics approval number [1] 299240 0
17852
Ethics committee name [2] 299242 0
Sydney Catholic Schools
Ethics committee address [2] 299242 0
Ethics committee country [2] 299242 0
Australia
Date submitted for ethics approval [2] 299242 0
27/10/2017
Approval date [2] 299242 0
01/11/2017
Ethics approval number [2] 299242 0
201731
Ethics committee name [3] 303270 0
The University of Sydney, Human Research Ethics Committee
Ethics committee address [3] 303270 0
Ethics committee country [3] 303270 0
Australia
Date submitted for ethics approval [3] 303270 0
13/11/2018
Approval date [3] 303270 0
15/11/2018
Ethics approval number [3] 303270 0
HREC 2018/864

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

Contacts
Principal investigator
Name 79770 0
A/Prof Nicola Newton
Address 79770 0
The Matilda Centre, Level 6 Jane Foss Russell Building, University of Sydney, Camperdown NSW 2006
Country 79770 0
Australia
Phone 79770 0
+61 2 8627 9030
Fax 79770 0
+61 2 8627 8145
Email 79770 0
[email protected]
Contact person for public queries
Name 79771 0
Nicola Newton
Address 79771 0
The Matilda Centre, Level 6 Jane Foss Russell Building, University of Sydney, Camperdown NSW 2006
Country 79771 0
Australia
Phone 79771 0
+61 2 8627 9030
Fax 79771 0
+61 2 8627 8145
Email 79771 0
[email protected]
Contact person for scientific queries
Name 79772 0
Nicola Newton
Address 79772 0
The Matilda Centre, Level 6 Jane Foss Russell Building, University of Sydney, Camperdown NSW 2006
Country 79772 0
Australia
Phone 79772 0
+61 2 8627 9030
Fax 79772 0
+61 2 8627 8145
Email 79772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In accordance with our ethical obligations as outlined by the University of Sydney HREC (HREC 2018/864), we must ensure the privacy of the participants in our study and as such, the individual participant data in this trial will not be available.


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
No additional documents have been identified.