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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]

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

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

Prevention

Comparator / control treatment

Control students will receive the drug education normally provided in their schools.

Control group

Active

Outcomes

Primary outcome [1]

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]

Timepoint 1: eight months subsequent to baseline
Timepoint 2: 20 months subsequent to baseline
Timepoint 3: 32 months subsequent to baseline

Secondary outcome [1]

Nil

Timepoint [1]

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]

Government body

Name [1]

Australian Research Council

Address [1]

Postal Address:
GPO Box 2702,
Canberra ACT 2601

Location:
Level 2,
11 Lancaster Place,
Majura Park ACT 2609

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Victorian Department of Education and Early Childhood

Address [2]

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 [2]

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]

Commercial sector/Industry

Name [1]

Victorian Department of Education and Early Childhood Development

Address [1]

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]

Australia

Secondary sponsor category [2]

University

Name [2]

The University of Melbourne

Address [2]

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]

Australia

Other collaborator category [1]

University

Name [1]

Oxford Brookes University

Address [1]

Jack Straw Lane
Marston
Oxford OX 0BP
United Kingdom

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Edith Cowan University Human Research Ethics Committee

Ethics committee address [1]

Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/03/2010

Ethics approval number [1]

5010 MIDFORD

Summary

Brief summary

Young people are faced with numerous and powerful influences to use both licit and illicit drugs, and drug education can play an important counterbalancing role in shaping a normative culture of safety, moderation and informed decision making. The aim of this research is to develop and evaluate the harm reduction effect of a comprehensive, evidence based school drug education program for year eight and nine students in a large, representative sample of Victorian government high schools.

Trial website

Trial related presentations / publications

MIDFORD, R., CAHILL, H., RAMSDEN, R., DAVENPORT, G., LESTER, L., MURPHY, B., POSE, M. (2011) Alcohol prevention: what can be expected of a harm reduction focused school drug education program? Drugs; Education, Prevention and Policy, Early Online: 1-9. Retrieved [11 January 2012] from http://informahealthcare.com/doi/full/10.3109/09687637.2011.639412 

CAHILL, H., POSE, M., FOSTER, R., VENNING, L., MIDFORD, R., RAMSDEN, R., Teacher take-up of participatory methods: Digging deeper through classroom observation and teacher interviews. 6th International Conference on Drugs and Young People, Melbourne, 2nd -4th May 2011.

MIDFORD, R., DAVENPORT, G., CAHILL, H., RAMSDEN, R., VENNING, L., LESTER, L., MURPHY, B., POSE, M. (2011) What can realistically be expected of school drug education? Findings from a school drug education pilot research project in Victoria. 6th International Conference on Drugs and Young People, Melbourne, 2nd -4th May 2011.

MIDFORD, R., VENNING, L., CAHILL, H., LESTER, L., RAMSDEN, R., POSE, M. (2011) One size does not fit all: Victorain lower secondary students’ experiences with alcohol across the state. 6th International Conference on Drugs and Young People, Melbourne, 2nd -4th May 2011.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Richard Midford

Address

Edith Cowan University
Mount Lawley Campus
Mount Lawley, WA 6050

Country

Australia

Phone

+61 8 93706508

Fax

+61 8 9370 6022

r.midford@ecu.edu.au

Contact person for scientific queries

Name

Richard Midford

Address

Edith Cowan University
Mount Lawley Campus
Mount Lawley, WA 6050

Country

Australia

Phone

+61 8 93706508

Fax

+61 8 9370 6022

r.midford@ecu.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Drug education in Victorian schools (DEVS): the study protocol for a harm reduction focused school drug education trial.	2012	https://dx.doi.org/10.1186/1471-2458-12-112
Embase	Alcohol prevention and school students: Findings from an Australian 2-year trial of integrated harm minimization school drug education.	2014	https://dx.doi.org/10.1177/0047237915579886
Dimensions AI	Alcohol prevention for school students: Results from a 1-year follow up of a cluster-randomised controlled trial of harm minimisation school drug education	2017	https://doi.org/10.1080/09687637.2017.1290788

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

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Documents added automatically