Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001038987
Ethics application status
Approved
Date submitted
22/07/2020
Date registered
12/10/2020
Date last updated
23/08/2022
Date data sharing statement initially provided
12/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of "Strong & Deadly Futures", a computerised, school-based, alcohol and other drug prevention program for Aboriginal and Torres Strait Islander students
Scientific title
Strong & Deadly Futures: A cluster randomised controlled trial of a computerised school-based alcohol and tobacco use prevention program for Aboriginal and Torres Strait Islander students
Secondary ID [1] 301577 0
GNT1163416
Universal Trial Number (UTN)
U1111-1252-7975
Trial acronym
SDF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use
 317945 0
Tobacco use

 317946 0
Psychological Distress 317947 0
Cannabis use 317948 0
Condition category
Condition code
Mental Health 315978 315978 0 0
Addiction
Public Health 316014 316014 0 0
Health promotion/education
Mental Health 317033 317033 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strong & Deadly Futures is a culturally inclusive school-based alcohol and other drug use prevention program that features computerised delivery to enhance engagement, reach and sustainability. The program incorporates core skill development and harm minimisation components from the effective "Climate Schools" school-based prevention program, and has been adapted in collaboration with Aboriginal and Torres Strait Islander stakeholders to be culturally inclusive and highlight Aboriginal and Torres Strait Islander cultural strengths.
The program aligns with the Australian Health and Physical Education curriculum and is designed to be delivered in Year 7/8 health education classes. The program consists of six lessons, which take approximately 45-60 minutes each to complete, and are optimally delivered once a week for six weeks.

The 6 lessons cover the content:
1. Coping with psychological distress
2. Alcohol education: short term consequences and harm minimisation
3. Alcohol and tobacco education: normative messaging, role models, helping a friend, finding information about alcohol and other drugs
4. Alcohol and tobacco education: Alcohol and other drug refusal strategies, peer pressure and alternatives to using alcohol and other drugs
5. Cannabis: Long term consequences of alcohol and other drug use, coping with other people’s alcohol and other drug use
6. Alternatives to alcohol and other drug use

Students and teachers access the program content by creating accounts on the website www.strongdeadly.org.au. Each lesson includes 10-minutes of computerised, illustrated stories covering key learning outcomes and 20-40 minutes of classroom activities for the teacher to deliver. Student accounts provide access to the illustrated stories and student lesson summaries. Teacher accounts provide access to the stories, teacher summaries, and a selection of class activity options (e.g. pre-specified worksheets, discussion topics and activities). Teachers are able to choose from a range of approximately six activity options for each lesson, one of which focuses on Aboriginal and Torres Strait Islander cultural identity and strengths. Six months after the six lessons, two booster sessions are delivered to help students refresh the content. Booster sessions are delivered a week apart, and follow the same structure as the original program.

Teachers are primarily responsible for implementing Strong & Deadly Futures. To assess implementation fidelity, teachers will record lesson procedures and activities on an online logbook accessed via their Strong & Deadly Futures website account. A local Aboriginal and/or Torres Strait Islander facilitator will be employed to assist teachers in each school, particularly to support classroom activities related to cultural strengths. The facilitators will also assist with survey administration, measurement of implementation fidelity through lesson observations. All local facilitators will receive research training and regular supervision and mentoring from the research team. Students will complete surveys at pre- and post-intervention, and at 12- and 24-months follow-up to assess intervention effects.

Facilitation Training
Facilitators will attend a series of workshops with the research team to support the pre-trial community consultation phase and RCT implementation.
Facilitators will attend three 1-hour online workshops before the community consultation sessions to explain the research process, purpose and procedure of the consultation phase. These will take place in the month before community consultation sessions commence; anticipated to occur between October 2021 and April 2022. Facilitators will also be provided access to the Strong & Deadly Futures program materials to familiarise themselves with the program content.
Facilitators will attend workshops before the trial implementation phase, anticipated to be in approximately May-June 2022. For the Strong & Deadly Futures group, there will be two 1-hour online workshops with the research team to discuss program implementation, survey administration and troubleshoot any technical issues. Teachers will be provided with online access to the Strong & Deadly Futures website to familiarise themselves with the program content and materials. For the waitlist control group, there will be one 1-hour online workshop with the research team to discuss aspects related to survey administration, and to troubleshoot technical issues relating to survey access.
A handbook will be developed for facilitators covering all workshop content, materials (i.e. consultation protocols, surveys), and frequently asked questions. The handbook materials for the consultation phase will be provided to facilitators in advance of the consultation workshops, and materials for the trial phase provided in advance of the trial workshops
Intervention code [1] 317903 0
Prevention
Intervention code [2] 317904 0
Lifestyle
Intervention code [3] 317905 0
Behaviour
Comparator / control treatment
The comparator/control treatment will be health education as usual. Participants in the control condition will receive their usual curriculum-based health education classes for 45-60 minutes a lesson, once a week for six weeks. Classes will serve as an ‘active control, and will naturally vary in content and delivery across schools. Teachers will be asked to complete online logbooks to detail class content and delivery methods throughout the trial period.
Participants will complete the post-intervention surveys at six weeks post-baseline, and at 12- and 24-months follow-up. After the completion of the 24-month follow-up survey, control schools will be offered the Strong & Deadly Futures program to implement with Year 8 students in 2024.
Control group
Active

Outcomes
Primary outcome [1] 324217 0
Alcohol use assessed using measures adapted from the National Drug Strategy Household Survey (AIHW, 2020) for the Climate Schools trials (Newton et al, 2009, Teesson et al, 2014; Teesson et al, 2017).
Timepoint [1] 324217 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months (primary endpoint) post-baseline
Primary outcome [2] 324218 0
Tobacco use, assessed using a single item from the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).
Timepoint [2] 324218 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months (primary endpoint) post-baseline
Primary outcome [3] 324219 0
Psychological distress, as measured by the MK-K5, a culturally modified version of the Kessler 5 Psychological Distress Scale validated for use in Aboriginal and Torres Strait Islander people (Brinkley, Calabria, Walker, Thurber & Lovett, 2021)
Timepoint [3] 324219 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months (primary endpoint) post-baseline
Secondary outcome [1] 384093 0
Cannabis use, assessed using items adapted from the National Drug Strategy Household Survey (AIHW, 2019) for the Climate Schools trials (Newton, 2009; Teesson et al, 2014; Teesson et al, 2017) (Note. Assessed in NSW public and QLD independent schools only, due to varying ethics committee policies)
Timepoint [1] 384093 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [2] 384094 0
Binge drinking, (defined as 5 or more standard drinks on single occasion), assessed using aa measure adapted from the School Health and Alcohol Harm Reduction Project (McBride et al, 2004) for the Climate Schools trials (Newton, 2009; Teesson et al, 2014; Teesson et al, 2017).
Timepoint [2] 384094 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [3] 384874 0
Alcohol-related harms, assessed by an adapted version of the Rutgers Alcohol Problems Index (White & Labouvie, 1989), abbreviated to form a 9-item version for the Climate and Preventure study (Newton et al, 2012).
Timepoint [3] 384874 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [4] 384875 0
Knowledge of harms and risk minimisation strategies related to alcohol, tobacco and cannabis. Alcohol and cannabis knowledge will be assessed using items adapted from the School Health and Alcohol Harm Reduction Project (McBride, 2004), as used in previous Climate Schools studies (Newton et al, 2010; 2009; Vogl et al, 2009; 2014). Tobacco knowledge will be assessed using a scale adapted from the Health4Life study (Teesson et al, 2020), the School Health and Alcohol Harm Reduction Project (McBride, 2004), and the Life Skills Training questionnaire (National Health Promotion Associates Incorporated, 2004).
Timepoint [4] 384875 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [5] 384876 0
Intentions to use alcohol, tobacco and cannabis will be assessed using a single item measure used in previous Climate Schools studies (Newton, 2009; Teesson et al, 2014).
Timepoint [5] 384876 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [6] 384877 0
Psychological wellbeing, as measured by the Personal Wellbeing Index – School Children (Tomyn et al 2013)
Timepoint [6] 384877 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [7] 384878 0
Empowerment, as measured by the Emotional Empowerment Scale from the Growth and Empowerment Measure (Haswell et al, 2010).
Timepoint [7] 384878 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [8] 384879 0
Appreciation of cultural diversity, as measured by the adapted Diversity Attitudes scale from the Civic Attitudes and Skills Questionnaire (Moely et al, 2011).
Timepoint [8] 384879 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline
Secondary outcome [9] 384880 0
Truancy rates, measured as days absent from school without explanation, collected by self report and from schools where possible and permitted by ethics committee requirements.
Timepoint [9] 384880 0
Assessed at baseline, and at 6-weeks, 12-months and 24-months post-baseline

Eligibility
Key inclusion criteria
• Year 7 and/or 8 students attending participating schools in 2022
• Fluent in English
• Active student consent provided
• Passive parental consent to participate (QLD Independent schools and NSW public schools) or active parental consent to participate (QLD public and WA independent schools; differing protocols due to varying ethics committee requirements).
Minimum age
11 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Schools with fewer than 12 Aboriginal and/or Torres Strait Islander students in Year 7 and/or 8 in 2022
- Schools based outside NSW, WA, and QLD

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)
Allocation will be concealed. Schools will be randomly allocated to groups by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following school recruitment, randomisation, stratified by remoteness, will be conducted by a biostatistician with no role in school recruitment using the Blockrand function in R. Remoteness will be classified using the Remoteness Areas Structure within the Australian Statistical Geography Standard, and defined as: Metro/inner regional (major cities, inner regional) and Outer regional/remote (outer regional, remote, very remote). Stratification will be used for balancing randomisation, and will not be a source of disaggregation during analyses.
Half of the schools will be randomly allocated to the Strong & Deadly Futures condition, and half to an active control condition (Year 7/8 health education as usual). Cluster randomisation will be used to avoid contamination of the controls by the intervention group through student communication. As is the case for school-based interventions of this kind, students and teachers will not be blind to intervention allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster RCT
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations:
The sample size has been calculated to account for cluster randomisation, using methods developed by Heo & Leon which allow us the detection of intervention by time interactions in longitudinal cluster RCTs. This trial is powered to detect differences in the subsample of Aboriginal and Torres Strait Islander students, as well as the overall sample. To adequately power the trial for comparisons among Aboriginal and Torres Strait Islander students, a minimum of 264 Aboriginal and Torres Strait Islander students from 22 schools are required (i.e. 12 Aboriginal and Torres Strait Islander students per school and 11 schools in each group). This would achieve 80% power to detect a standardised between-group mean difference of 0.3 (p = 0.05) in primary alcohol and other drug use-related outcomes at the end of the trial with four measurement occasions. An effect size of 0.3 is comparable to that found for these continuous alcohol and other drug use outcomes in previous school-based prevention trials in mainstream populations (no effect size information was available for school-based prevention for Aboriginal and Torres Strait Islander students). Based on previous research, we conservatively allow for 30% attrition among Aboriginal and Torres Strait Islander students. Therefore we will recruit 24 schools with an average of 16 Aboriginal and Torres Strait Islander students per school and a total of 40 students per school. This totals to 960 students, of which 384 would be Aboriginal and Torres Strait Islander.

Statistical analyses:
Due to the hierarchical nature of the data, outcome analyses will use multi-level mixed effects regression models (modelled using Stata) and will take into account clustering of data at the school level. Multilevel modelling accounts for the expected correlations between repeated measurements from the same individual and between individuals in the same school which would otherwise violate assumptions of independence in traditional regression models. The models will take into account individual differences at baseline, estimating participant-specific starting points and change over time from these baseline levels. Randomly allocated group (Strong & Deadly Futures vs Health education as usual) will be identified by dummy-coding and entered as an independent variable. Hypothesised program effects on alcohol and tobacco uptake, psychological wellbeing and secondary outcomes will be assessed by examining the Strong & Deadly Futures group vs. the health education as usual group by time interaction effects. Analyses will examine program effects specifically among Aboriginal and Torres Strait Islander students, with a secondary analysis conducted in the full sample. All analyses will be conducted according to the intention-to-treat principle, using all available measurements from participants and according to their allocated group. Missing data will be accommodated based on all available information using maximum likelihood (ML) estimation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
25/07/2022
Date of last participant enrolment
Anticipated
22/12/2022
Actual
Date of last data collection
Anticipated
22/12/2024
Actual
Sample size
Target
960
Accrual to date
276
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 306003 0
Government body
Name [1] 306003 0
National Health and Medical Research Council (Project Grant)
Country [1] 306003 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 306465 0
None
Name [1] 306465 0
Address [1] 306465 0
Country [1] 306465 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306238 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 306238 0
Ethics committee country [1] 306238 0
Australia
Date submitted for ethics approval [1] 306238 0
28/11/2019
Approval date [1] 306238 0
09/04/2020
Ethics approval number [1] 306238 0
USYD HREC 2020/039
Ethics committee name [2] 306489 0
Aboriginal Health and Medical Research Council
Ethics committee address [2] 306489 0
Ethics committee country [2] 306489 0
Australia
Date submitted for ethics approval [2] 306489 0
26/11/2019
Approval date [2] 306489 0
19/02/2020
Ethics approval number [2] 306489 0
AHMRC HREC 1620/19
Ethics committee name [3] 306490 0
NSW State Education Research Applications Process (SERAP)
Ethics committee address [3] 306490 0
Ethics committee country [3] 306490 0
Australia
Date submitted for ethics approval [3] 306490 0
24/04/2020
Approval date [3] 306490 0
01/06/2020
Ethics approval number [3] 306490 0
SERAP number 2020170
Ethics committee name [4] 306491 0
Western Australian Aboriginal Health Ethics Committee (WAAHEC
Ethics committee address [4] 306491 0
Ethics committee country [4] 306491 0
Australia
Date submitted for ethics approval [4] 306491 0
16/09/2020
Approval date [4] 306491 0
06/10/2020
Ethics approval number [4] 306491 0
WAAHEC ref number: 998
Ethics committee name [5] 306493 0
QLD Department of Education Ethics Committee
Ethics committee address [5] 306493 0
Ethics committee country [5] 306493 0
Australia
Date submitted for ethics approval [5] 306493 0
16/10/2020
Approval date [5] 306493 0
11/08/2021
Ethics approval number [5] 306493 0
550/27/2390
Ethics committee name [6] 309638 0
Catholic Education WA
Ethics committee address [6] 309638 0
Ethics committee country [6] 309638 0
Australia
Date submitted for ethics approval [6] 309638 0
12/10/2020
Approval date [6] 309638 0
18/11/2020
Ethics approval number [6] 309638 0
Approval no: 2020/39
Ethics committee name [7] 311503 0
Kimberley Aboriginal Health Planning Forum Research Subcommittee
Ethics committee address [7] 311503 0
Ethics committee country [7] 311503 0
Australia
Date submitted for ethics approval [7] 311503 0
05/07/2021
Approval date [7] 311503 0
02/08/2021
Ethics approval number [7] 311503 0
App:2021-027

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

Contacts
Principal investigator
Name 103210 0
A/Prof Lexine Stapinski
Address 103210 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103210 0
Australia
Phone 103210 0
+61 2 8627 9039
Fax 103210 0
Email 103210 0
lexine.stapinski@sydney.edu.au
Contact person for public queries
Name 103211 0
Lexine Stapinski
Address 103211 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103211 0
Australia
Phone 103211 0
+61 2 8627 9039
Fax 103211 0
Email 103211 0
lexine.stapinski@sydney.edu.au
Contact person for scientific queries
Name 103212 0
Lexine Stapinski
Address 103212 0
Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 103212 0
Australia
Phone 103212 0
+61 2 8627 9039
Fax 103212 0
Email 103212 0
lexine.stapinski@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8573Study protocolStapinski L, Routledge K, Snijder M, Doyle M, Champion K, Chapman C, Ward J, Baumgart A, Lee KK, Teesson M, Newton N. A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Study Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc 2021;10(12):e34530. doi: 10.2196/34530 lexine.stapinski@sydney.edu.au Available in published study protocol.
8574Statistical analysis planStapinski L, Routledge K, Snijder M, Doyle M, Champion K, Chapman C, Ward J, Baumgart A, Lee KK, Teesson M, Newton N. A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Study Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc 2021;10(12):e34530. doi: 10.2196/34530 lexine.stapinski@sydney.edu.au Available in published study protocol.



Results publications and other study-related documents

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