Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000079842
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
School drug education for junior high school students in Victoria - Assessing the impact of a state-wide, evidence-based intervention
Scientific title
School drug education for junior high school students in Victoria - Assessing the impact of a state-wide, evidence-based intervention designed to reduce harm
Secondary ID [1] 279710 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and other drug use and harm 285545 0
Condition category
Condition code
Public Health 285738 285738 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cluster randomised school drug education trial will be conducted with 1746 junior high school students in 21 Victorian secondary schools (14 intervention, 7 control) over a period of three years. Both the schools and students have actively consented to participate in the study. The education program comprises ten lessons of approximately an hour in year eight (13-14 year olds) and eight in year nine (14-15 year olds) that address issues around the use of alcohol, tobacco, cannabis and other illicit drugs. The lessons will be provided in a block each year at approximately weekly intervals by teachers within the school who have previously received training in their delivery. Control students will receive the drug education normally provided in their schools. Students will be tested at baseline, at the end of each intervention year and also at the end of year ten. A self completion questionnaire will be used to collect information on knowledge, patterns and context of use, attitudes and harms experienced in relation to alcohol, tobacco, cannabis and other illicit drug use. Multi-level modelling will be the method of analysis because it can best accommodate hierarchically structured data. All analyses will be conducted on an Intent-to-Treat basis. In addition, focus groups/interviews will be conducted with students and teachers in 5 of the 14 intervention schools, subsequent to delivery of the year eight and nine programs. The student focus groups will be one hour in duration with a roughly even mix of six to eight males and females. Teacher interviews will be with either individuals, or small groups of two to three respondents. They will be one hour in length. These focus groups and interviews will provide qualitative data about the effectiveness of the lessons and the relevance of the materials.
Intervention code [1] 284010 0
Prevention
Intervention code [2] 284039 0
Lifestyle
Intervention code [3] 284040 0
Behaviour
Comparator / control treatment
Control students will receive the drug education normally provided in their schools.
Control group
Active

Outcomes
Primary outcome [1] 286265 0
Intervention students will consume alcohol, tobacco and illicit drugs in a less risky manner and experience less harms associated with use. This will be assessed by a student self report questionnaire.
Timepoint [1] 286265 0
Timepoint 1: eight months subsequent to baseline
Timepoint 2: 20 months subsequent to baseline
Timepoint 3: 32 months subsequent to baseline
Secondary outcome [1] 295469 0
Nil
Timepoint [1] 295469 0
Nil

Eligibility
Key inclusion criteria
Actively consenting year eight students (consent by student and parent) from the the 21 Victorian secondary schools that agreed to participate in the study
Minimum age
13 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Year eight students from the the 21 participating Victorian secondary schools who did not actively consent (no consent from student or parent)

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)
Twenty one Victorian government high schools agreed to participate in the study. The schools were then allocated to four strata: six schools to metro location, high SES; three schools to rural location, high SES; six schools to metro location, low SES; six schools to rural location, low SES. This approximated the proportion of Victorian secondary schools in each category. Within each strata the schools were then randomly allocated to intervention or control conditions on a two to one proportion to allow more precise statements about the effects of the intervention. Random allocation and allocation concealment were achieved by one member of the research team writing the names of each school on identical paper chits which were then folded to conceal the name. The same researcher also created seven chits with the word control and 14 with the word intervention. These were similarly folded to conceal the words. The chits with the school name and those designating allocation were placed in separate containers. A different member of the team then simultaneously drew out a chit with the name of a school and a chit designating either control or intervention allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a nested design whereby the allocation of students is determined by the allocation of their school to either the intervention or control condition
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1746
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284492 0
Government body
Name [1] 284492 0
Australian Research Council
Country [1] 284492 0
Australia
Funding source category [2] 284493 0
Commercial sector/Industry
Name [2] 284493 0
Victorian Department of Education and Early Childhood
Country [2] 284493 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Mount Lawley Campus
2 Bradford Stret
Mount Lawley, WA 6050
Country
Australia
Secondary sponsor category [1] 283418 0
Commercial sector/Industry
Name [1] 283418 0
Victorian Department of Education and Early Childhood Development
Address [1] 283418 0
Postal Address:
Department of Education and Early Childhood Development
GPO Box 4367
Melbourne, Victoria 3001

Location:
33 St Andrews Place,
East Melbourne, Victoria 3001
Country [1] 283418 0
Australia
Secondary sponsor category [2] 283419 0
University
Name [2] 283419 0
The University of Melbourne
Address [2] 283419 0
Postal address:
The University of Melbourne
Victoria 3010

Street address:
Grattan Street, Swanston Street or Elizabeth Street in the Melbourne suburb of Parkville.
Country [2] 283419 0
Australia
Other collaborator category [1] 260433 0
University
Name [1] 260433 0
Oxford Brookes University
Address [1] 260433 0
Jack Straw Lane
Marston
Oxford OX 0BP
United Kingdom
Country [1] 260433 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286474 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286474 0
Ethics committee country [1] 286474 0
Australia
Date submitted for ethics approval [1] 286474 0
Approval date [1] 286474 0
22/03/2010
Ethics approval number [1] 286474 0
5010 MIDFORD

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

Contacts
Principal investigator
Name 33619 0
Address 33619 0
Country 33619 0
Phone 33619 0
Fax 33619 0
Email 33619 0
Contact person for public queries
Name 16866 0
Richard Midford
Address 16866 0
Edith Cowan University
Mount Lawley Campus
Mount Lawley, WA 6050
Country 16866 0
Australia
Phone 16866 0
+61 8 93706508
Fax 16866 0
+61 8 9370 6022
Email 16866 0
[email protected]
Contact person for scientific queries
Name 7794 0
Richard Midford
Address 7794 0
Edith Cowan University
Mount Lawley Campus
Mount Lawley, WA 6050
Country 7794 0
Australia
Phone 7794 0
+61 8 93706508
Fax 7794 0
+61 8 9370 6022
Email 7794 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
SourceTitleYear of PublicationDOI
EmbaseDrug education in Victorian schools (DEVS): the study protocol for a harm reduction focused school drug education trial.2012https://dx.doi.org/10.1186/1471-2458-12-112
EmbaseAlcohol prevention and school students: Findings from an Australian 2-year trial of integrated harm minimization school drug education.2014https://dx.doi.org/10.1177/0047237915579886
Dimensions AIAlcohol prevention for school students: Results from a 1-year follow up of a cluster-randomised controlled trial of harm minimisation school drug education2017https://doi.org/10.1080/09687637.2017.1290788
N.B. These documents automatically identified may not have been verified by the study sponsor.