ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000723785

Ethics application status

Approved

Date submitted

28/06/2013

Date registered

1/07/2013

Date last updated

4/09/2023

Date data sharing statement initially provided

11/07/2019

Date results information initially provided

11/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The CSC intervention: A comprehensive universal internet-based intervention to prevent anxiety, depression, substance use, and related harms in Australian adolescents aged 13 to 16 years.

Scientific title

The CSC intervention: A comprehensive universal internet-based intervention to prevent anxiety, depression, substance use, and related harms in Australian adolescents aged 13 to 16 years.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1141-6746

Trial acronym

CSC Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Substance use prevention

Prevention of substance use related harms

Depression prevention

Anxiety prevention

Condition category

Condition code

Mental Health

Addiction

Mental Health

Depression

Mental Health

Anxiety

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participating secondary schools will be randomly allocated to one of four groups.

Group 1:
The Control condition: One group will serve as the control group and receive their usual school drug and mental health education. The following groups will receive one of the following three study interventions:

Group 2:
The Climate Schools-Substance Use (CS-SU) intervention 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 twelve 40-minute lessons delivered as part of the Year 8 (Year 9 in QLD) Health and Physical Education syllabus. The first six lessons will be delivered in Term 1, 2014 during consecutive Health and Physical education classes (approximately 1 lesson per week). The remaining six lessons will be delivered in Term 3, 2014 in consecutive Health and Physical education classes (approximately 1 lesson per week).

The first part of each lesson is completed individually over the internet. During this part of the lesson students are engaged through cartoon story lines that impart information about the short and long term effects of alcohol and cannabis, normative alcohol and cannabis use, refusal skills, and first aid. The second part of each lesson is a group or class activity delivered by the teacher, and reinforces the information in the cartoons, while allowing 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. The first six lessons focus specifically on alcohol and are delivered approximately six months prior to the remaining six lessons which focus on cannabis.

Group 3:
The Climate Schools-Mental Health (CS-MH) intervention aims to reduce anxiety and depression symptoms, and to prevent the development of associated disorders later in life. The program consists of six 40-minute lessons delivered as part of the Year 9 (Year 10 in QLD) Health and Physical Education syllabus. The six lessons will be delivered in Term 1,2015 in consecutive Health and Physical education classes (approximately 1 lesson per week). The lessons are structured in the same way as the Climate Schools-Substance Use intervention. The content of the lessons focuses on identifying and effectively dealing with anxiety and depression symptoms. The six lessons are designed to be run consecutively within one school Term.

Group 4:
The Climate Schools Combined (CSC) Intervention will deliver both the Climate Schools-Substance Use and the Climate Schools-Mental Health interventions consecutively, as described above. The CSC intervention simultaneously targets mental health and substance use, as it is known that the two commonly co-occur and share common risk factors.

For those groups receiving an intervention, teachers will be asked to complete a log book at the end of the intervention to document adherence to the intervention and record which activities they implemented in the classroom. As students are required to log in to complete the study intervention online records will indicate student completion rates.

Regardless of group, teachers will be asked at the end of each year during the study period to record any other drug, alcohol or mental health education that was delivered to students participating in the trial, that was in addition to the Climate Schools courses.

CSC LONG TERM FOLLOW UP 2018-2022
The CSC long-term follow up is an opportunistic extension of the landmark CSC study, whereby follow up of this cohort will extend beyond the completion of secondary school and into the critical transition period of early adulthood. The investigators will extend longitudinal follow-up for a further 5 years, inviting the participants to take part in two additional online surveys assessing demographic information, drinking and drug use habits, mental health systems, health service use and behavioural and personality inventories. Consent will also be sought to link to participants MBS and PBS data. A cost-effectiveness analysis will also examine the cost-effectiveness of the prevention program. This extended follow-up component was added after initial recruitment for Phase 1 of the CSC trial, run between 2014 – 2017.

Intervention code [1]

Prevention

Comparator / control treatment

The Climate Schools Combined (CSC) Intervention will be compared to:

a) A "standard treatment" control group - Students will not receive the Climate Schools-Substance Use or Mental Health interventions. Participants will complete their standard Year 8 and Year 9 (Year 9 & 10 in QLD) Health and Physical Education classes, delivered by their usual teacher.

b) The Climate Schools-Substance Use only intervention - Students will receive 12 x 40-minute lessons delivered as part of the Year 8 (Year 9 in QLD) Health and Physical Education syllabus. Each lesson consists of an interactive computer component and class activities from the program manual, administered by their usual teacher.

c) The Climate Schools-Mental Health only intervention - Students will receive 6 x 40-minute lessons delivered as part of the Year 9 (Year 10 in QLD) Health and Physical Education syllabus. Each lesson consists of computer lessons and activities from the program manual, to be administered by their usual teacher.

Control group

Active

Outcomes

Primary outcome [1]

Use and harmful use of alcohol and cannabis. Students will be asked to rate the frequency and quantity of their alcohol consumption in standard drinks, frequency of drinking to excess (defined as having more than five standard drinks on a single occasion), and age of first alcohol consumption. These questions are 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. Cannabis and other drug use will be measured by questions based on the National Drug Strategy Household Survey (NDHS), 2010, and the Australian Secondary Students Alcohol and Drug Survey (ASSAD), 2011. This allows for comparison between use in the current sample and a large scale representative group of Australians. Long-term follow-up:
Alcohol and cannabis use: Drinking frequency and binge drinking will be assessed using an adapted version of the Patterns of Alcohol Index. A shortened version of the Patterns of Cannabis Use instrument, will be used to measure use and frequency of cannabis use.

Timepoint [1]

Assessed at baseline and at 6, 12, 18, 24 and 30 months after study commencement. Long-term follow-up: Primary outcomes will be assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post-intervention.

Primary outcome [2]

Overall anxiety/depression levels . The ‘Kessler 6 plus’ scale (K6+) will be used to assess psychological distress in the past month. Depression symptoms will be measured using the ‘Patient Health Questionnaire 8’ (PHQ8), while anxiety symptoms will be measured by the ‘Generalised Anxiety Disorder 7-item scale’ (GAD-7). The 3-item ‘Mini Social Phobia Inventory’ (mini-SPIN) will assess social anxiety symptoms. The ‘Strengths and Difficulties Questionnaire’ (SDQ) will be used to assess both positive and negative attributes of the students. Long-term follow-up: Primary outcome 2: Symptoms of anxiety & depression: The K6+, PHQ-9 and GAD-7 will be used to assess overall anxiety/depression levels.

Timepoint [2]

Primary outcome [3]

Anxiety, depression and substance use knowledge.

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. Participants’ knowledge about cannabis will be assessed by 16 items from the ‘Knowledge about Cannabis’ scale used in previous CLIMATE Schools trials. Participants’ knowledge about coping with anxiety and depression will be assessed from 7 questions that cover appraisal, reality focused and emotion focused coping.

Timepoint [3]

Assessed at baseline and at 6, 12, 18, 24 and 30 months after study commencement.

Secondary outcome [1]

Alcohol use related harms. Alcohol related harms will be assessed using the 23-item Rutgers Alcohol Problem Index (RAPI). Long-term follow-up: Alcohol use related harms and consequences of drinking alcohol will be assessed by the Brief Young Adult Alcohol Consequences Questionnaire. Probable diagnosis of alcohol use disorder will be measured using a self-report symptom checklist based on DSM-5 criteria. Probable diagnosis of cannabis use disorder will be measured using a self-report symptom checklist based on DSM-5 criteria. Other drug use will be measured by questions based on the National Drug Strategy Household Survey (NDHS), 2010, and the Australian Secondary Students Alcohol and Drug Survey (ASSAD), 2011. Frequency and quantity of current and past tobacco and e-cigarette use will also be measured with study-specific questionnaire.

Timepoint [1]

Assessed at baseline and at 6, 12, 18, 24 and 30 months after study commencement. Long-term follow-up: Secondary outcomes will be assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post-intervention.

Secondary outcome [2]

Peer alcohol use. Peer alcohol use will be measured by the self-reported proportion of friends who drink alcohol.

Long-term follow-up: Peer alcohol and cannabis use will be measured by the self-reported proportion of friends who drink alcohol and who use cannabis.

Timepoint [2]

Secondary outcome [3]

Self-efficacy to resist peer pressure.

The 10-item ‘Resistive Self-Regulatory Efficacy Scale’ will be used to measure participants’ perceived efficacy to resist peer pressure to engage in high risk activities.

Timepoint [3]

Secondary outcome [4]

General disability. Quality of life will be measured by the ‘Child Health Utility 9D’ (CHU 9D) and days out of role will be measured by the ‘Kessler 6 plus’ scale (K6+).

Timepoint [4]

Secondary outcome [5]

Truancy.

Truancy will be measured by asking the number of days students had off without their parents’ permission in the previous school year.

Timepoint [5]

Assessed at baseline and at 6, 12, 18, 24 and 30 months after study commencement.

Secondary outcome [6]

The Link between personality and substance use. The Substance Use Risk Profile Scale (SURPS) will be used to assess for variation in personality risk for substance abuse/dependence along 4 dimensions: Sensation Seeking, Impulsivity, Anxiety Sensitivity and Hopelessness.

Long-term follow-up: The personality trait of perfectionism will be measured by the Brief Frost Multidimensional Perfectionism Scale

Timepoint [6]

The SURPS is assessed at baseline and at 6, 12, 18, 24 and 30 months after study commencement. Long-term follow-up: The personality trait of perfectionism will be assessed long-term via the administration of an additional follow-up survey 5 years post intervention.

Secondary outcome [7]

Moderators of the primary outcomes listed above in primary outcome boxes 1-3 (and measured through the scales detailed in the primary outcome 1-3 boxes above) will be also be examined including, baseline risk in relation to substance use (measured through self-report alcohol and other drug consumption and related-harms) and mental health symptoms (measured through the self-report PHQ-A, GAD-7, K6, Mini-spin and SDQ).

Timepoint [7]

Secondary outcome [8]

Long-term follow-up: Suicide risk. Three questions from the Youth Risk Behaviour System will assess thoughts and plans in relation to suicide.

Timepoint [8]

Long-term follow-up: Assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Secondary outcome [9]

Long-term follow-up: Psychotic experiences. The Community Assessment of Psychic Experiences-Positive Scale (CAPE-P15) will assess psychotic symptoms in the past 3 months.

Timepoint [9]

Long-term follow-up: Assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Secondary outcome [10]

Long-term follow-up: Emotion regulation will be assessed through the Emotion Regulation Questionnaire (ERQ).

Timepoint [10]

Long-term follow-up: Assessed long-term via the administration of a follow-up survey, 5 years post intervention.

Secondary outcome [11]

Long-term follow-up: Peer networks. To investigate social networks and how patterns of behaviour develop in relation to substance use and mental health, participants will be asked to nominate their six closest friends. They will also be asked to report on their social connections with up to six people with whom they spent their free time over the past 12 months. These questions include measures of frequency and mode of contact, relationships, closeness, how many are considered drinking associates and perceived mental health symptoms of these people.

Timepoint [11]

Long-term follow-up: Assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Secondary outcome [12]

Long-term follow-up: Cost effectiveness. The cost effectiveness of the intervention will be assessed through self-report questions measuring resource use, including health service visits, type, and costs, as well as linkage to Medicare data. Medication use will be measured through self-report and linkage to PBS data. Work capacity, receipt of government support and housing will also be measured via self-report questions.

Timepoint [12]

Long-term follow-up: Assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Secondary outcome [13]

Long-term follow-up: Psychological Distress. The Distress Questionnaire 5 (DQ5) and the ‘Kessler 6 plus’ scale (K6+) will assess general psychological distress in relation to the past 30 days. The 3-item ‘Mini Social Phobia Inventory’ (mini-SPIN) will assess social anxiety symptoms. The ‘Strengths and Difficulties Questionnaire’ (SDQ) will be used to assess both positive and negative attributes of the students.

Timepoint [13]

Assessed long-term via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Eligibility

Key inclusion criteria

All students (both male and female) aged between 13-14 years, in Year 8 of Secondary School at the beginning of the trial in 2014, (except for QLD students who will be in Year 9 of Secondary School at the beginning of the trial).

Long-term follow-up: Those that participated at baseline will be eligible to continue with the study, via the administration of two additional follow-up surveys spanning 5 and 7 years post intervention.

Minimum age

13 Years

Maximum age

14 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Non consenters – parental and student

Long-term follow-up: Those who did not participate in the baseline survey and who do not provide consent to take part in the long-term follow up study are not eligible to take part in the two long-term follow-up surveys spanning 5 and 7 years post intervention.

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 four study groups using the rall function of the statistical program Stata. 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 statistical program Stata (simple randomisation using computer software).

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 were based on recent sample size requirements developed by Heo & Leon (Heo & Leon, 2009) to detect intervention by time interactions in longitudinal cluster randomized clinical trials. The CSC trial will be powered to detect differences in the overall sample as well as across the three States of NSW, QLD and WA. To allow for comparisons in each State, six schools (with at least 100 students) in each of the four intervention groups are required per state, giving a total of 24 schools (with at least 2400 students) per State. This achieves 80 per cent power to detect a standardized between-group mean difference of 0.15 (p = 0.05) in outcomes at the end of the trial with seven measurement occasions. An effect size of 0.15 is comparable to previous school-based trials of universal mental health and substance use prevention programs (Cuijpers, van Straten, Smit, Mihalopoulos, & Beekman, 2008; Teesson, Newton, & Barrett, 2012; Vogl et al., 2009) and would have substantial benefits on a population level based on recent economic modelling (Nherera & Jacklin, 2009). To account for school dropouts during the trial, which we expect to be approximately 10 per cent, we aim to recruit at least 28 schools (with at least 2800 students) in each State. This will result in an overall total of 8400 students from 84 schools at baseline to test the efficacy of the CS-C intervention in comparison to the other groups both nationally and state-wide. Based on previous research using the CLIMATE Schools programs, school participation rates for similar trials are approximately 30 per cent (Newton, Andrews, Teesson, & Vogl, 2009; Vogl et al., 2009). Therefore, to recruit a total of 84 schools, approximately 270 schools will be approached to participate.
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. 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 variance within State or schools, intervention effects will primarily be examined using hierarchical linear modelling (HLM) for normally distributed data and hierarchical generalized linear modeling using a Poisson distribution for count data. Outcome variables will be entered 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-state or 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. OR and 95% CI will also be calculated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2014

Actual

1/11/2013

Date of last participant enrolment

Anticipated

28/02/2014

Actual

28/02/2014

Date of last data collection

Anticipated

31/12/2021

Actual

6/07/2021

Sample size

Target

8400

Accrual to date

Final

6386

Recruitment in Australia

Recruitment state(s)

NSW,QLD,WA

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council
Australian Government Department of Health and Ageing

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Maree Teesson

Address

The Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02)
University of Sydney NSW 2006

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The Matilda Centre for Research in Mental Health and Substance Use

Address [1]

Level 6, Jane Foss Russell building (G02),
University of Sydney, NSW 2006

Country [1]

Australia

Secondary sponsor category [2]

Charities/Societies/Foundations

Name [2]

Australian Rotary Health

Address [2]

PO Box 3455,
Parramatta NSW 2124

Country [2]

Australia

Other collaborator category [1]

University

Name [1]

Clinical Research Unit for Anxiety and Depression, UNSW and St Vincents Hospital

Address [1]

Clinical Research Unit for Anxiety and Depression (CRUfAD)
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Sydney Australia

Country [1]

Australia

Other collaborator category [2]

University

Name [2]

Curtin University

Address [2]

Kent St
Bentley WA 6102

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Queensland University of Technology

Address [3]

2 George St
Brisbane QLD 4000

Country [3]

Australia

Other collaborator category [4]

University

Name [4]

University of Queensland

Address [4]

St Lucia
QLD 4072

Country [4]

Australia

Other collaborator category [5]

University

Name [5]

Deakin University

Address [5]

Burwood Campus,
221 Burwood Hwy
Burwood VIC 3125

Country [5]

Australia

Other collaborator category [6]

University

Name [6]

The University of New South Wales

Address [6]

High St, Kensington, NSW 2052

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales, Human Research Ethics Committee

Ethics committee address [1]

Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/05/2013

Ethics approval number [1]

HREC # HC13073

Ethics committee name [2]

The University of Sydney Human Research Ethics Committee

Ethics committee address [2]

Research Integrity & Ethics Administration
Research Portfolio
Level 3, Administration Building (F23)
University of Sydney NSW 2006

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

19/12/2018

Ethics approval number [2]

2018/906

Summary

Brief summary

The current study will evaluate an integrative internet-based approach to prevent mental health and substance use problems in adolescence. The intervention is known as Climate Schools Combined (CSC), and comprises of a twelve-lesson substance use course, and a six-lesson mental health course. Together the CSC program simultaneously targets alcohol, cannabis, depressive and anxiety disorders with the aim of reducing substance use and decreasing anxiety and depressive symptoms.

The study is being run in 71 schools across QLD, NSW and WA. The CSC intervention will be compared to the individual Climate Schools Substance Use intervention, the Climate Schools Mental Health intervention, and the control condition. The RCT will be conducted over three years, with the delivery of the Substance Use course in Year 8 (except QLD students whom will receive the course in Year 9) and the Mental Health course in Year 9 (Year 10 for QLD).

This study will be the first time such an intervention has been trialed, and is the first intervention designed to fit within the school syllabus to concurrently target substance use and mental health.

Long term follow up: The approved extended long-term follow up will provide the first ever evaluation of the long-term effectiveness of combining universal approaches to the prevention of substance use, anxiety and depression and will examine the durability of intervention effects into the longer-term, over a 7-year period from adolescence to early adulthood.

Trial website

www.cscstudy.org.au

Trial related presentations / publications

Published papers:

Teesson M., Newton N.C., Slade T., Chapman C., Allsop S., Hides L., McBride N., Mewton L., Tonks Z., Birrell L., Brownhill, L., Andrews, G. The CLIMATE schools combined study: a cluster randomised controlled trial of a universal Internet-based prevention program for youth substance misuse, depression and anxiety. BMC Psychiatry 2014, 14(1):32

Mewton, L., Kessler, R., Slade, T., Hobbs, M., Brownhill, L., Birrell, L., Tonks, Z., Teesson, M., Newton, N., Chapman, C., Allsop, S., Hides, L., McBride, N. Andrews, G. (2016) ‘The psychometric properties of the Kessler Psychological Distress Scale (K6) in a general population sample of adolescents’, Psychological Assessment, 28 (10): 1232 – 1242

Conference presentations:

Tonks, Z., Newton, N., Andrews, G., Slade, T., Chapman, C., Birrell, L., & Teesson, M. ‘The Climate Schools Combined (CSC) Study: Internet-based prevention for anxiety, depression and substance use in young Australians ’, Poster presentation, The Mental Health Services Conference , Melbourne, August 2013

Tonks, Z., Newton, N., Andrews, G., Slade, T., Chapman, C., Birrell, L., & Teesson, M. ‘The Climate Schools Combined (CSC) Study: Internet-based prevention for anxiety, depression and substance use in young Australians ’, Poster presentation, National Drug and Alcohol Research Centre Symposium, Sydney, September, 2013

Tonks, Z., Slade, T., Newton, N., Teesson, T., Chapman, C., Birrell, L., Mattick R., Kypri, K., Bruno, R., Najman, J., McBride, N., Hutchinson, D., Wadolowski, M., & Aiken, A. ‘The role of alcohol-specific rules on adolescent drinking trajectories in an Australian sample’, Oral presentation, Society for Mental Health Research Conference, Adelaide, Australia, December, 2014

Slade, T., Chapman, C., Turner, B., Shaw, B., Newton, N., Birrell, L., Tonks, Z., Mewton, L., Teesson, M. ‘Social networks and the spread of alcohol use attitudes and behaviors in Australian adolescents’, Oral presentation, XXXV Sunbelt Conference of the International Network for Social Network Analysis, Brighton, U.K., June, 2015

B., Shaw, Slade, T., Newton, N., Chapman, C., Andrews, G., Birrell, L., Tonks, Z., Mewton, L., Allsop, S., Hides, L., McBride, N., Te Pas, N., Firmin-Sarra, S., Pocuca, N., & Teesson, M. ‘Baseline characteristics of The CSC Study: An innovative internet-based universal prevention trial for alcohol, cannabis and mental health problems in adolescents’, Poster presentation, Centre of Research Excellence in Mental Health and Substance Use Annual Colloquium, Canberra, Australia, August, 2015

Pas, N., McBride, N., Newton, N., Slade, T., Chapman, C., Andrews, G., Mewton, L., Allsop, S., Hides, L., Birrell, L., Pocuca, N., Firmin-Sarra, S., Tonks, Z., B., Shaw, & Teesson, M. ‘Substance use and harms in young Australians’, Poster presentation, The Australasian Professional Society on Alcohol and Other Drugs Conference, Perth, Australia, November, 2015

Chapman, C., Shaw, B., Birrell, L., Newton, N., Slade, T., Andrews, G., Mewton, L., Allsop, S.,
Te Pas, N., McBride, N., Chapman, C., Hides, L., Pocuca, N., Firmin-Sarra, S., Tonks, Z., & Teesson, M. ‘Substance use and harms in young Australians’, Poster presentation, The Australasian Professional Society on Alcohol and Other Drugs Conference, Perth, Australia, November, 2015

Birrell, L., Newton, N., Slade, T., Chapman, C., Andrews, G., Mewton, L., Allsop, S., McBride, N., Hides, L., Te Pas, N., Pocuca, N., Firmin-Sarra, S., Tonks, Z., Shaw, B., Teesson, M., ‘Mental health and substance use prevention in schools: The climate schools combined study’, Oral presentation, Society for Mental Health Research Conference, Brisbane, Australia, December, 2015

Slade, T., Chapman, C., Turner, B., Shaw, B., Newton, N., Birrell, L., Tonks, Z., Mewton, L., Teesson, M. Changes in friendship networks and the link between mental health and alcohol use. Paper presented at World Congress of Behavioural and Cognitive Therapies, Melbourne, Australia, June, 2016

Chapman, C., Shaw, B., Birrell, L., Newton, N., Slade, T, Andrews, G., Mewton, L., Allsop, S., Hides, L., McBride, N., Te Pas, N., Pocuca, N., Firmin-Sarra, S., Tonks, Z., Teesson, M. The Climate Schools Combined (CSC) Study: Internet-based prevention for anxiety, depression and substance use in young people. Paper presented at The Mental Health Services Conference of Australia and New Zealand, Auckland, NZ, (August, 2016)

Chapman, C., Shaw, B., Birrell, L., Newton, N., Slade, T., Andrews, G., Mewton, L., Allsop, S., Hides, L., McBride, N., Te Pas, N., Pocuca, N., Firmin-Sarra, S., Tonks, Z., Teesson, M. The Climate Schools Combined (CSC) Study: Internet-based prevention for anxiety, depression and substance use in young people. Paper presented at The National Drug and Alcohol Research Centre Annual Symposium, Sydney, Australia (September, 2016)

Birrell, L., Shaw, B., Chapman, C., Newton, N., Slade, T., Andrews, G. , Allsop, S., McBride, N., Hides, L., Mewton, L., Te Pas, N., Pocuca, N., Firmin-Sarra, S., Tonks, Z., & Teesson, M., ‘The CSC Study: An Internet-based universal prevention trial for alcohol, cannabis and mental health problems in adolescence’, Oral presentation, Centre of Research Excellence in mental Health and Substance Use Annual Colloquium, Sydney, Australia, December, 2016

Shaw, B., Slade, T.. Newton, N.,Chapman, C., Mewton, L., Andrews, G. , Allsop, S., McBride, N., Hides, L., Birrell, L., Te Pas, N., Pocuca, N., Firmin-Sarra, S., Tonks, Z., & Teesson, M., ‘The CSC Study: An Internet-based universal prevention trial for alcohol, cannabis and mental health problems in adolescence’, Oral presentation, Society of Mental Health Research, Sydney, Australia, December, 2016

Teesson, M., Birrell L, Newton, N., Slade T., Chapman, C., Mewton, L., Allsop, S., Hides, L., McBride, N., Shaw, B., Andrews, G. The Climate Schools Combined Study. Mental health outcomes of a combined approach to preventing substance use and mental health problems amongst adolescents, Poster presentation, 39th Annual Meeting of the Society of Behavioural Medicine, New Orleans, Louisiana, USA April, 2018

Pocuca, Nina,Hides, Leanne,Quinn, Catherine A.,White, Melanie J.,Mewton, Louise,Newton, Nicola Clare,Slade, Tim,Chapman, Cath,Andrews, Gavin,Teesson, Maree,Allsop, Steve,McBride, Nyanda. The interactive effects of personality profiles and perceived peer drinking on early adolescent drinking. Psychology of Addictive Behaviors, Vol 32(2), Mar 2018, 230-236

Public notes

Contacts

Principal investigator

Name

Prof Maree Teesson

Address

The Matilda Centre for Research in Mental Health and Substance Use, JFR Building G02, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 8627 9048

Fax

+61 2 8627 8145

maree.teesson@sydney.edu.au

Contact person for public queries

Name

Prof Maree Teesson

Address

The Matilda Centre for Research in Mental Health and Substance Use, JFR Building G02, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 8627 9048

Fax

+61 2 8627 8145

maree.teesson@sydney.edu.au

Contact person for scientific queries

Name

Prof Maree Teesson

Address

The Matilda Centre for Research in Mental Health and Substance Use, JFR Building G02, The University of Sydney, NSW, 2006

Country

Australia

Phone

+61 2 8627 9048

Fax

+61 2 8627 8145

maree.teesson@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified individual participant survey data from all assessment waves (baseline, 6-, 12-, 15-, 18-, 24-, 30-, 60- and 72- month follow-ups)

When will data be available (start and end dates)?

As per the CSC Study authorship and data sharing guidelines, data is currently available and will be available for at least 20 years.
Waves 1-9: available from 1st July 2022 until 1st July 2042

Available to whom?

Data are potentially available to researchers from not-for-profile organizations, commercial organisations/other and based in any location. All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. The statistical analysis code (syntax) and data collected for the study, including de-identified participant data, will be made available to researchers on request to the corresponding author and with appropriate reason when accompanied by study protocol and analysis plan. Data will be shared after the approval of a proposal by a committee of the current research team with a signed data access agreement. Informed consent forms are available in the published protocol.
For further information, see our data sharing policy (https://www.sydney.edu.au/policies/showdoc.aspx?recnum=PDOC2014/366&RendNum=0).

Available for what types of analyses?

Any type of analysis (IPD meta-analysis, systematic review, and other research questions) assessed on a case-by-case basis.

How or where can data be obtained?

As of 1st July 2022, access can be requested through the research team. Data request will be reviewed on a case by case basis.

Email contact: louise.birrell@sydney.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2949	Study protocol	Birrell L, Newton NC, Slade T, Chapman C, Mewton L, McBride N, et al. Evaluating the Long-Term Effectiveness of School-Based Depression, Anxiety, and Substance Use Prevention Into Young Adulthood: Protocol for the Climate School Combined Study. JMIR Research Protocols. 2018;7(11):e11372.	https://www.researchprotocols.org/2018/11/e11372/
20232	Ethical approval					364519-(Uploaded-13-07-2023-10-46-29)-Study-related document.pdf
20233	Analytic code			louise.birrell@sydney.edu.au	Analytic code will be made available upon email re... [More Details]
20234	Statistical analysis plan					364519-(Uploaded-13-07-2023-10-48-30)-Study-related document.pdf
20235	Informed consent form					364519-(Uploaded-13-07-2023-10-46-29)-Study-related document.docx
20236	Other				Including a spreadsheet of survey measures include... [More Details]	364519-(Uploaded-13-07-2023-10-46-54)-Study-related document.xlsx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Teesson, M., Newton, N. C., Slade, T., Chapman, C.... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Combined prevention for substance use, depression, and anxiety in adolescence: a cluster-randomised controlled trial of a digital online intervention.	2020	https://dx.doi.org/10.1016/S2589-7500%2819%2930213-4
Embase	Bidirectional relationships in the development of internalising symptoms and alcohol use in adolescence.	2020	https://dx.doi.org/10.1111/dar.13070
Embase	A national effectiveness trial of an eHealth program to prevent alcohol and cannabis misuse: responding to the replication crisis.	2022	https://dx.doi.org/10.1017/S0033291720001919

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically