Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000355471
Ethics application status
Approved
Date submitted
21/06/2007
Date registered
3/07/2007
Date last updated
3/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
CLIMATE Schools: Alcohol Module. The feasibility and efficacy of a universal school-based computerised prevention program for alcohol misuse and related harms.
Scientific title
CLIMATE Schools: Alcohol Module. The feasibility and efficacy of a universal school-based computerised prevention program for alcohol misuse and related harms.
Universal Trial Number (UTN)
Trial acronym
CLIMATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorders and alcohol related harms 1912 0
Condition category
Condition code
Mental Health 2003 2003 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CLIMATE Schools: Alcohol Module is a computerised universal prevention program delivered as part of the Personal Development, Health and Physical Education (PDHPE) Syllabus for New South Wales. This intervention is based on a comprehensive social influence model. The CLIMATE Schools: Alcohol Module consists of a six lesson harm minimisation program aimed at decreasing alcohol misuse and related harms. Each of the lessons is broken into two components. The first is a 15-20 minute computer module. The second part involves the choice of one or more interactive class based activities which have been prepared in a program manual. The control schools received PDHPE classes as usual. The alcohol prevention programs delivered in the CONTROL schools were also social influence programs based on a harm minimisation approach. Effectively, the content of the prevention program was the same content as was delivered in the CONTROL schools. The main difference between the two interventions was the mode of delivery (computer delivered intervention coupled with interactive class activities).
Intervention code [1] 1845 0
Prevention
Comparator / control treatment
Placebo will be in the form of a saline solution administered subcutaneously.
Control group
Active

Outcomes
Primary outcome [1] 2826 0
Knowledge of alcohol related harms and information to minimise alcohol related harm.

These questions were adapted from the School Health and Harm Reduction Project Survey Instrument (McBride, Midford, Farringdon and Phillips, 2000).
Timepoint [1] 2826 0
Baseline, immediate, 6, 12 and 24 months post intervention
Primary outcome [2] 2827 0
Alcohol consumption
1.Frequency of consumption per week (average) (past 12 months)
2. Frequency of consumption per week (average) (past 3 months)
3. Quantity of consumption per occasions (average) (past 12 months)
4.Quantity of consumption per occasions (average) (past 3 months)
5. Frequency of drinking at risky and high risk levels of consumption in past 12 months (i.e., . 4 standard drinks per occasion for females and 6 standard drinks per occasion for males)
6. Maximum number of drinks consumed on a single occasion in the past 12 months
7. Context of consumption*
8. Harms caused by a person’s own alcohol consumption*
9. Harms experienced by the person as a result of other alcohol consumption

These questions were adapted from the School Health and Harm Reduction Project Survey Instrument (McBride, Midford, Farringdon and Phillips, 2000).
Timepoint [2] 2827 0
Baseline, immediate, 6, 12 and 24 months post intervention
Secondary outcome [1] 4771 0
1.Alcohol Expectancy Questionnaire – Adolescent Form (Brown, Christiansen and Goldman, 1987). Scale 2 ‘alcohol can enhance or impede social behaviour’ was the only scale administered.
2. CDI – Short Version – Childrens’ Depression Inventory (Kovacs, 2005)
3. Multidimensional Anxiety Scale for Children (MASC-10) (March, 1997)
4. Life time use of Cannabis
Timepoint [1] 4771 0
Time points questionnaire administered: Baseline, immediate, 6,12 and 24 months post intervention
Secondary outcome [2] 4772 0
5. Peer alcohol use measure.
Timepoint [2] 4772 0
Time points questionnaire administered: Immediate, 6 and 12 months post intervention

Eligibility
Key inclusion criteria
Students currently enrolled in year 8 of high school who provide self and parental consent. schools: Catholic and Independent high schools.
Minimum age
Maximum age
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Randomisation occurred at the level of school (not at the individual student). Schools were invited to participate in the condition to which they had been allocated as determined by a random allocation schedule. The condition to which schools were allocated was not concealed from the schools. However, students were not informed about the use of a CONTROL versus INTERVENTION to ensure this did not bias responding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation process was completed by an independent researcher, who developed a randomisation schedule for schools using a coin tossing procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1858
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2146 0
Government body
Name [1] 2146 0
Australian Government Department of Health and Ageing
Country [1] 2146 0
Australia
Funding source category [2] 2147 0
University
Name [2] 2147 0
National Drug and Alcohol Research Centre
Country [2] 2147 0
Australia
Primary sponsor type
Individual
Name
Maree Teesson
Address
Country
Secondary sponsor category [1] 1948 0
Individual
Name [1] 1948 0
Laura Vogl
Address [1] 1948 0
Country [1] 1948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3942 0
University of New South Wales Human Research Ethics Committee-Catholic, Idependent and Government Schools in Australia
Ethics committee address [1] 3942 0
Ethics committee country [1] 3942 0
Date submitted for ethics approval [1] 3942 0
Approval date [1] 3942 0
19/09/2006
Ethics approval number [1] 3942 0
HREC 06252

Summary
Brief summary
The aim is to assess the feasibility and efficacy of an evidence-based computer-driven alcohol prevention program for year 8 of high school. Currently, evidence-based programs do exist, but are largely not implemented in schools due to implementation (e.g., limited resources and teacher training) and dissemination failure. The aim of developing CLIMATE Schools: Alcohol Module is to overcome such concerns by developing a computer-driven intervention which would have the advantage of providing complete, consistent and flexible delivery on every occasion, without demanding excess teacher’s time, resources and training. CLIMATE Schools: Alcohol Module would also have the potential advantage of being an interactive program which would allow high-risk populations, who often do not seek help, to seek help with relative anonymity and confidentiality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27659 0
Address 27659 0
Country 27659 0
Phone 27659 0
Fax 27659 0
Email 27659 0
Contact person for public queries
Name 11034 0
Laura Vogl
Address 11034 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 11034 0
Australia
Phone 11034 0
+61 2 9385 0278
Fax 11034 0
+61 2 9385 0222
Email 11034 0
[email protected]
Contact person for scientific queries
Name 1962 0
Laura Vogl
Address 1962 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW, 2052
Country 1962 0
Australia
Phone 1962 0
+61 2 9385 0278
Fax 1962 0
+61 2 9385 0222
Email 1962 0
[email protected]

No information has been provided regarding IPD availability


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.