Trial Review

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
ACTRN12620000805976
Ethics application status
Approved
Date submitted
4/06/2020
Date registered
10/08/2020
Date last updated
4/10/2022
Date data sharing statement initially provided
10/08/2020
Date results information initially provided
29/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Community trial of a new harm minimisation program for young people
Scientific title
The Illicit Project community trial: evaluation of a school-based, harm minimisation program for young people
Secondary ID [1] 301445 0
Nil.
Universal Trial Number (UTN)
U1111-1252-9539
Trial acronym
TIP RCT
Linked study record
The link study record is a community pilot study of the Illicit Project (see below) and provides feasibility and evaluation data from students and teachers across Sydney.

Debenham J, Birrell L, Champion K, et al. A pilot study of a neuroscience-based, harm minimisation programme in schools and youth centres in Australia. BMJ Open 2020;10:e033337. doi:10.1136/ bmjopen-2019-033337

PMCID: PMC7044936

Health condition
Health condition(s) or problem(s) studied:
Substance Use 317759 0
Risk taking 317760 0
Condition category
Condition code
Public Health 315827 315827 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The educational program that is being trialled is called 'The Illicit Project' and is a school-based, 3-class drug education program accessed via the internet. The evidence-based program was designed to upskill young people in harm minimisation strategies to reduce substance use related harm. Adherence will be measured through students completion rates, measured through an online widget. Students will receive an email with a log-in link to the program, on the first occasion, using personalised computers, they will complete the baseline questionnaire and register to the program. On the second, third and fourth class, students will use individual computers to work progressively through the three modules during class time. The three modules are called [1] The Brain and Alcohol [2] Illicit Drugs and Harm Reduction and [3] Addiction, Mental Health and Wellbeing (module 3 is shorter and followed by the post-program questionnaire); and students will have the opportunity to download/ print a one page factsheet for each module. Module 1 and Module 2 run for around 40minutes whilst Module 3 runs for around 20minutes and is followed by a post-program questionnaire. The four classes required for the baseline questionnaire, 3 class e-modules and the post program questionnaire will be administered within one term of school (around 12weeks) from October 2020-December 2020. Within the 12 weeks, schools are offered flexibility to administer the four classes in any frequency, as long as the program has been completed administrated by December 2020.
Intervention code [1] 317760 0
Prevention
Intervention code [2] 317876 0
Behaviour
Intervention code [3] 317877 0
Lifestyle
Comparator / control treatment
Participants will be randomised into intervention or control arm of the study by the High School that they attend. There will be 6 High Schools in the control group whom will receive health classes as per normal and are considered the active control group. For grade 10 students, health classes will be the normal Personal Development, Health and Physical Education (PDHPE) classes that all of the state receive. For grade 11 and 12 students attending public schools, health classes per normal will include 'Life Ready', which is a mandatory 25-hour course designed to support senior students as they encounter situations related to health and safety. Schools select from optional classes around relationships, safe sex, substance use, mental health etc. and implement a customised program for their school. For grade 11 and 12 students attending independent schools, whilst there are no mandatory health classes, schools implement personal development classes through camps, retreats and spare periods focused on developing health and wellbeing skills.
Control group
Active

Outcomes
Primary outcome [1] 324027 0
Outcome 1: Risky use of alcohol and other drugs. Quantity and frequency of drug use in the past 6 months will be assessed using items created by our research team and used in previous school-based trials such as the Climate Schools intervention (Teesson, Newton et al., 2017; Teesson et al., 2014). Students will be asked to report the frequency and quantity of drinking alcohol, including drinking to excess (>5 drinks on one occasion) and other illicit substances. The questionnaire will be assessed through a de-identified study-specific online questionnaire, accessed separately from the online modules.

Self-reported alcohol and substance use has been shown to be reliable and valid (Del Boca et al., 2003), with accuracy increasing when assurances of confidentiality are made and surveys are administered online, both of which will occur in this trial.
Timepoint [1] 324027 0
Baseline, T3=6months post intervention; T4=12 months post intervention (primary endpoint).
Primary outcome [2] 324028 0
Outcome 2: Alcohol harms. Students who have drunk alcohol in the past 6 months will complete the 18-item Rutgers Alcohol Problem Index (RAPI; White and Labouvie, 1989). RAPI was developed for 12-18year olds and has been frequently used as an outcomes measure in clinical trials among adolescents. The questionnaire will be assessed through a de-identified study-specific online questionnaire, accessed separately from the online modules.
Timepoint [2] 324028 0
Baseline, T3=6months post intervention; T4=12 months post intervention (primary endpoint).
Primary outcome [3] 324029 0
Drug Literacy Levels will be measured through a 25-item drug literacy questionnaire including knowledge, attitudes and skills around substance use, which was developed by the research team for this particular intervention. This measure has been used in a pilot study of the current program (Debenham et al., 2019). The questionnaire will be assessed through a de-identified study-specific online questionnaire, accessed separately from the online modules.
Timepoint [3] 324029 0
Baseline, T3=6months post intervention; T4=12 months post intervention (primary endpoint).
Secondary outcome [1] 383589 0
Perceptions of harm as measured by the 14-item Beliefs about consequences scale, which originates from the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) ‘Beliefs about Consequences’ instrument (European Monitoring Centre for Drugs and Drug Addiction, 2004), used to examine young people’s attitudes to illicit drugs and how they perceived the consequences of drug use. The questionnaire will be assessed through a de-identified study-specific online questionnaire, accessed separately from the online modules.
Timepoint [1] 383589 0
Baseline, T3=6months post intervention; T4=12 months post intervention (primary endpoint).
Secondary outcome [2] 383590 0
Intentions to use drugs (including alcohol), measured by a 5-point Likert scale measure future intentions to use substances, this has been used in many of our previous school-based trials (Teesson, Newton et al., 2017; Teesson et al., 2014). The questionnaire will be assessed through a de-identified study-specific online questionnaire, accessed separately from the online modules.
Timepoint [2] 383590 0
Baseline, T3=6months post intervention; T4=12 months post intervention (primary endpoint).

Eligibility
Key inclusion criteria
High School students in the Greater Sydney area (Australia) in grades 10, 11 or 12 (aged 15-19years)
Minimum age
15 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students in grades 7-9 in High Schools outside of the Greater Sydney area, Australia.

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 after recruitment was complete so the researchers were blinded the allocation of each group during to study inclusion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
The current trial is powered to detect differences in the overall student sample across four-time points. Three schools, with at least 60 students per school, are required per intervention group. This would achieve 80% power to detect a standardized, between-group mean difference of 0.3 (p = 0.05) in primary outcomes at the end of the trial, with 4 measurement occasions. An effect size of 0.3 is comparable to previous trials of universal student programs (Champion et al., 2016; Hodder et al 2017). To account for school dropouts during the trial, which we expect to be approximately 10%, we aim to recruit at least eight schools in total. Assuming that the majority (if not all) students in the year group take part in the study as per the pilot study (approximately 100 on average), this will give us a total of 800 students from eight schools at baseline to test the effect of the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2020
Actual
1/09/2020
Date of last participant enrolment
Anticipated
30/09/2020
Actual
1/12/2020
Date of last data collection
Anticipated
30/12/2022
Actual
17/12/2021
Sample size
Target
800
Accrual to date
Final
950
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305881 0
University
Name [1] 305881 0
The Matilda Centre, the University of Sydney
Country [1] 305881 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] 306335 0
None
Name [1] 306335 0
Address [1] 306335 0
Country [1] 306335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306142 0
USYD HREC
Ethics committee address [1] 306142 0
92/94 Parramatta Rd, Camperdown NSW 2050
Ethics committee country [1] 306142 0
Australia
Date submitted for ethics approval [1] 306142 0
Approval date [1] 306142 0
28/04/2020
Ethics approval number [1] 306142 0
2020/053

Summary
Brief summary
The Illicit Project is a neuroscience-based, drug education program designed for High School students aged 16-19years. The three-class program aims to upskill and empower young people to make informed health decision and reduce the harms of substance use. We hypothesise that the program will help to reduce the risky use of alcohol and other drugs and the associated harms over the short-term.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102854 0
Dr Louise Birrell
Address 102854 0
The Matilda Centre, the University of Sydney, NSW, 2006
Country 102854 0
Australia
Phone 102854 0
+61 2 8627 9003
Fax 102854 0
Email 102854 0
[email protected]
Contact person for public queries
Name 102855 0
Ms Jennifer Debenham
Address 102855 0
The Matilda Centre, the University of Sydney, NSW, 2006
Country 102855 0
Australia
Phone 102855 0
+61 2 8627 9010
Fax 102855 0
Email 102855 0
[email protected]
Contact person for scientific queries
Name 102856 0
Ms Jennifer Debenham
Address 102856 0
The Matilda Centre, the University of Sydney, NSW, 2006
Country 102856 0
Australia
Phone 102856 0
+61 2 8627 9010
Fax 102856 0
Email 102856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the data collected (around substance use behaviours) the individual participant data will not be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8165Study protocol    The study protocol will be detailed in the publica... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes April 2022 Debenham, J., Champion, K., Birrell,... [More Details] 379949-(Uploaded-30-09-2022-01-09-44)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a neuroscience-based, harm reduction program for older adolescents: A cluster randomised controlled trial of the Illicit Project.2022https://dx.doi.org/10.1016/j.pmedr.2022.101706
EmbaseStudy protocol for a cluster randomised controlled trial of The Illicit Project, a digital, neuroscience-based substance use intervention for secondary school students.2021https://dx.doi.org/10.1016/j.cct.2021.106467
N.B. These documents automatically identified may not have been verified by the study sponsor.