ANZCTR - Registration

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12607000312448

Ethics application status

Approved

Date submitted

6/06/2007

Date registered

13/06/2007

Date last updated

28/04/2024

Date data sharing statement initially provided

26/11/2018

Date results provided

28/04/2024

Type of registration

Retrospectively registered

Titles & IDs

Public title

CLIMATE Schools

Scientific title

CLIMATE Schools: A high school web-based prevention program to prevent the misuse of Alcohol and Cannabis in schools.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Alcohol and cannabis misuse

Condition category

Condition code

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Intervention Condition - Students in this condition recieve Alcohol and cannabis prevention through the CLIMATE Schools program. This program entails 12 lessons on Alcohol and Cannabis knowledge, use, harms and attitudes. These lessons are taught in year 8 as part of the PDHPE curriculum, replacing existing drug and alcohol preventinon. Each lesson is made up of two parts; the first being reading of cartoons where the students view a group of friends their age experimenting with alcohol and cannabis and learning drug refusal skills. The first part is done via the internet where students logon with individual logins and view the cartoons. The second part of each lesson is run by the teacher and involves class, individual or group activities provided in the manual we give schools.

Intervention code [1]

Prevention

Comparator / control treatment

The Control Condition - Students in this condition recieve their usual PDHPE classes on drug and alcohol.

Control group

Active

Outcomes

Primary outcome [1]

Alcohol and Cannabis Use

Timepoint [1]

Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.

Secondary outcome [1]

Alcohol and Cannabis knowledge

Timepoint [1]

Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.

Secondary outcome [2]

Alcohol and Cannabis attitudes

Timepoint [2]

Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.

Secondary outcome [3]

Alcohol and cannabis harms.

Timepoint [3]

Measured pre intervention (baseline), directly after intervention (immediate post), and at 6, 12 and 24 months follow up points.

Eligibility

Key inclusion criteria

Year 8 students. Consent to study.

Minimum age

13 Years

Maximum age

15 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Does not consent.

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)

This study is a cluster RCT so all students within a particular school will be assigned to the same condition. Schools were randomly allocated to act as control or intervention schools. This was done using an internet randomizing program and again by a blind person who picked them out using sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Internet program called Randomizer

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Baseline equivalence and attrition between groups were examined using single-level analyses. A series of one-way analyses of variance were used to analyse normally distributed data, the c2 test to examine binominal data and the Mann–Whitney U-test to examine non-normally distributed data.

To account for intracluster correlations between schools, intervention effects were examined primarily using hierarchical linear modelling (HLM) for normally distributed data (i.e. knowledge and expectancies) and hierarchical generalized linear modelling (HGLM) using a
Poisson sampling method for count data. Outcome variables were centred at post-test to allow for comparisons between groups immediately after the intervention and growth terms were analysed to determine the magnitude of the follow-up effects. Analyses were conducted using
the HLM 6 program [38]. If the unconditional model revealed that less than 10% of systematic variance existed at the between-school level, HLM was abandoned and single-level analyses were used [39]. The outcome variables with intra class correlations (ICCs) below 10% included average weekly alcohol consumption, frequency of drinking to excess, frequency of cannabis use and cannabis-related harms. Although these variables were not distributed normally, in the absence of available nonparametric mixed models Harris [40] recommends that standard ANOVA procedures are robust for skewed and proportional data. For each of these outcome variables ANOVAs utilizing the SPSS generalized linear model (GLM) procedure were conducted on change scores from baseline to each follow-up occasion, as they represented normal distributions more effectively and accounted for baseline differences between groups. Bonferroni adjustments were made for multiple comparisons to control the type 1 error rate.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2007

Actual

1/06/2006

Date of last participant enrolment

Anticipated

Actual

31/12/2006

Date of last data collection

Anticipated

Actual

31/12/2008

Sample size

Target

764

Accrual to date

Final

764

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Foundation for Alcohol Research & Education (Alcohol Education and Rehabilitation Foundation)

Address [1]

Level 1, 40 Thesiger Court, Deakin ACT 2600
PO Box 19 Deakin West ACT 2600

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Australian Research Council

Address [2]

Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
AUSTRALIA

Country [2]

Australia

Primary sponsor type

University

Name

University of New South Wales (UNSW)

Address

University of New South Wales (UNSW)
Sydney, NSW, 2052
Australia

Country

Australia

Secondary sponsor category [1]

University

Name [1]

National Drug and Alcohol Research Centre

Address [1]

NDARC, UNSW
Sydney, NSW, 2052
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Comittee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/06/2006

Ethics approval number [1]

06165

Summary

Brief summary

This RCT is designed to test weather the CLIMATE Schools Alcohol and Cannabis program is more successful in preventing Alcohol and cannabis use and related harms, compared to the current programs

Trial website

www.climateschools.com.au

Trial related presentations / publications

Newton, N. C., Vogl, L. E., Teesson, M., & Andrews, G. (2011). Developing the Climate Schools: Alcohol and Cannabis Module: A harm-minimisation, universal drug prevention program delivered over the internet. Substance Use and Misuse, 46 (13), 1654-1663.

Newton, N. C., Teesson, M., Vogl, L. E. & Andrews, G. (2010). Internet-based prevention for alcohol and cannabis use: Final results of the Climate Schools course. Addiction, 105, 749-759.

Newton, N. C., Andrews, G., Teesson, M., & Vogl, L. E. (2009). Delivering school-based prevention for alcohol and cannabis using the internet: A cluster randomised controlled trial. Preventive Medicine, 48, 579-584.

Newton, N. C., Vogl, L. E., Teesson, M., & Andrews, G. (2009). Climate Schools: Alcohol Module: A cross-validation of a school based prevention program for alcohol misuse. Australian and New Zealand Journal of Psychiatry, 43, 201-207.

Newton, N. C., Havard, A., & Teesson, M. (2012). The association between moral disengagement, psychological distress, resistive self-regulatory efficacy, and alcohol and cannabis use among adolescents in Sydney, Australia. Addiction Research & Theory, 20 (3), 261-269.

Vogl, L. E., Newton, N. C., Teesson, M., Swift, W., Karageorge, A. Deans, C., McKetin, R., Steadman, B. Jones, J. Dillon, P. Havard, A., & Andrews, G. (2012). Climate Schools: Drug prevention programs. NDARC Technical Report No. 321. ISBN 978-0-7334-3162-3. Sydney: National Drug and Alcohol Research Centre, UNSW.

Presentations:

Newton, N. C., Teesson, M., Vogl, L. Andrews, G., & Conrod, P. (2011). Effects of the ‘Climate Schools: Alcohol and Cannabis’ course in Australia and the UK. Presented at EABCT conference, Iceland, September 2011

Newton, N. C., Conrod, P. & Teesson, M. (2010). Effective school-based programs to prevent substance misuse, emotional problems and risky behaviour among adolescents. Invited plenary speaker at the VAD conference, Brussels, Belguim, Nov 201

Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2010). Universal drug prevention. Presented at the 6th world conference for the prevention of mental health disorders, Washington DC, US, Nov 2010. 

Teesson, M., Newton, N. C., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Prevention for alcohol and cannabis delivered over the internet. Presented at the European Association for Cognitive and Behavioural Therapy, Dubrovnik, Croatia, September, 2009.

Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Delivering prevention for alcohol and cannabis over the internet. Poster presented at the National Drug and Alcohol Research Centre Annual Symposium, Sydney, NSW, Sept 2009. 

Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Delivering prevention for alcohol and cannabis over the internet. Poster presented at the National Cannabis Prevention and Information Centre (NCPIC) Conference, Sydney, NSW, Sept 2009. 

Newton, N. C., & Teesson, M., Vogl, L. E., & Andrews, G. (2009). Climate Schools: Prevention for alcohol and cannabis delivered over the internet. Poster presented at the Research Society on Alcoholism Conference, San Diego, US, June 2009. 

Newton, N. C., & Teesson, M., Andrews, G. & Vogl, L. E. (2009). Delivering prevention for alcohol and cannabis over the internet. Poster presented at the College on Problems of Drug Dependence Conference, Reno, US, June 2009. 

Teesson, M., Newton, N. C., Vogl, L. E., & Andrews, G. (2008). Climate Schools: Evaluating the early results of a computerised alcohol and cannabis prevention program for high school. Presented at the Australian Professional Society on Alcohol and other Drugs, Sydney, NSW, Nov, 2008.	

Newton, N. C. (2007). Developing a computer-based drug prevention program for adolescents. Presented at the National Drug and Alcohol Research Centre In house seminar, Sydney, NSW, Nov 2008.

Newton, N. C. (2008). Climate Schools: The development and evaluation of a Year 8 computerised evidence-based alcohol and cannabis misuse prevention program. Presented at the National Drug and Alcohol Research Centre Annual Symposium, Sydney, NSW, August 2008.

Vogl, L. E. Teesson, M.., Andrews, G., Newton, N. C., & VanVliet, H. (2007).  Developing and implementing effective school-based drug prevention programs: CLIMATE Schools. Presented at the ACHPER National / International Biennial Conference, Perth, WA, December 2007.

Newton, N. C. (2006). Climate Schools: The development of a Year 8 computerised evidence-based alcohol and cannabis misuse prevention program. Presented at the School of Public Health and Community Medicine Student Conference, UNSW, Sydney, NSW, November 2006.

Newton, N. C. & Van Vliet, H. (2006). Climate Schools: The development and evaluation of a computer-based prevention program for adolescents. Presented at Young People’s Health: What’s it going to take Conference, Sydney, NSW, November 2006.

Public notes

Contacts

Principal investigator

Name

Dr Nicola Newton

Address

National Drug and Alcohol Research Centre University of New South Wales (UNSW)Randwick NSW2052

Country

Australia

Phone

+61 2 93850159

Fax

n.newton@unsw.edu.au

Contact person for public queries

Name

Nicola Newton

Address

National Drug and Alcohol Research Centre
University of New South Wales (UNSW)Randwick NSW2052

Country

Australia

Phone

+61 2 93850159

Fax

nickien@unsw.edu.au

Contact person for scientific queries

Name

Nicola Newton

Address

National Drug and Alcohol Research Centre
University of New South Wales (UNSW)
Randwick NSW 2052

Country

Australia

Phone

+61 2 93850159

Fax

nickien@unsw.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?

Participant data supporting the publication results and participant data relating to primary outcomes.

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

Data are available straight after publication.
Data are available for an indefinite time
Start date: April 2024 (approx)
End date: Unknown

Available to whom?

Data are potentially available to:
- Researchers from not-for-profit organisations
Based in:
- Any location
Further information:
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. For further information, see our data sharing policy (http://www.university.edu/datasharing policy).

Available for what types of analyses?

IPD meta-analysis or systematic review
Assessed on a case-by-case basis

How or where can data be obtained?

As of 22 April 2024, access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.
For further information, see our data sharing policy (http://www.university.edu/datasharing policy).

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.

Trial Review

Did you know?

Documents added manually

Documents added automatically