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
Help: Registration number
ACTRN12626000336381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/02/2026
Date registered
Help: Date registered
17/03/2026
Date last updated
Help: Date last updated
17/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/03/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The Mind Your Mate program: A school-based randomised controlled trial to evaluate the effectiveness of combined classroom lessons and a mobile app peer support prevention intervention.
Scientific title
The Mind Your Mate program: A school-based cluster randomised controlled trial to evaluate the effectiveness of combined classroom lessons and mobile app peer support prevention intervention for mental health and substance use.
Additional trial identifiers [1] 316569 0
N/A
Universal Trial Number (UTN)
Trial acronym
Related trial records
The current trial aims to evaluate the combined Mind Your Mate program encompassing the Mind Your Mate intervention evaluated in ACTRN12620000753954 and an additional classroom lesson program.

Health condition
Health condition(s) studied:
Mental Health 340729 0
Substance Use 340731 0
Condition category
Condition code
Mental Health 336919 336919 0 0
Anxiety
Mental Health 336920 336920 0 0
Depression
Public Health 336921 336921 0 0
Health promotion/education
Mental Health 336922 336922 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Mind your Mate program:
The Mind your Mate program is a school-based, universal intervention which aims to prevent mental health and substance use problems in adolescents. The intervention was developed through an iterative process with youth and education and health stakeholders and leverages a peer-based model to promote peer support and prevent mental health and substance use problems. The Mind your Mate Program is comprised of a classroom program and companion smartphone application (app), the Mind Your Mate app.

The classroom program is comprised of four, 40-minute classes delivered over four consecutive weeks. Classroom lessons consist of a 20-minute online cartoon component followed by a 20-minute classroom activity. Classroom lessons follow a group of Australian high school students navigating daily life and includes content on mental health literacy, ways to support peers and encourages help-seeking. The lessons will be facilitated by the regular classroom teacher but delivered online and include an invitation for students to download the companion app. Classroom lessons may be viewed by students on their individual devices or presented to the whole class together. Classroom activities, including individual worksheets, group discussions and class brainstorming, aims to reinforce information provided in the cartoon lessons and provides students an opportunity to collaborate with their peers and practice and apply teachings. Intervention content has been mapped to relevant Australian and state curricula. All classroom materials will be housed and accessible on the study website.

At the end of the first classroom lesson, students will be directed to download and work through the app outside of school hours, as needed, over the following 12 months. The app contains self-directed learning through online (in app) modules, each approximately 5-10 minutes (including mental health psychoeducation, substance use literacy and norms, harm minimisation strategies and communication skills to check in with friends) and suggested activities (for example, checking in with friends, testing knowledge via quizzes and tracking mood), and self-care tasks (for example, drawing, playing an instrument or sport) over a 12-month period.

Teachers do not require any additional training to deliver the program however, they will be provided with lesson summaries and curriculum mapping for review at their own discretion. It is expected that Year 9 and Year 10 Health and Physical Education teachers allocated to the intervention condition will introduce the program during their regular classes in Term 1, 2027.

Teachers in schools allocated to the intervention condition will be provided an implementation logbook to record fidelity and any related barriers or aids to implementation as well as a health education logbook to record any other relevant mental health or substance use content delivered during the trial period. Students in schools allocated to the intervention condition will be asked to complete a survey on their use of the app and provide feedback at 12-months (~10 minutes).
Intervention code [1] 333245 0
Prevention
Description of the comparator or control
Schools allocated to the control condition will implement health education as usual. In Australia, mandatory Stage 5 Health and Physical Education curriculum includes education on mental health and wellbeing content. As such, control schools will deliver regular curriculum-based health education during the trial period, expected to vary in delivery modes. Teachers in schools allocated to the control condition will be provided a health education logbook and asked to document any relevant mental health or substance use content delivered during the trial period (commencing Term 1, 2027). Schools allocated to the control condition will be offered the use of the intervention at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 344441 0
Intervention Knowledge
Timepoint [1] 344441 0
Baseline, post-intervention (approx. 4-weeks), 3-months (primary timepoint) and 12-months post-baseline.
Primary outcome [2] 344442 0
Mental Health Literacy
Timepoint [2] 344442 0
Baseline, post-intervention (approx. 4-weeks), 3-months (primary timepoint) and 12-months post-baseline.
Primary outcome [3] 344443 0
Strengths and Difficulties
Timepoint [3] 344443 0
Baseline, post-intervention (approx. 4-weeks), 3-months (primary timepoint) and 12-months post-baseline.
Secondary outcome [1] 457945 0
Depressive symptoms
Timepoint [1] 457945 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [2] 457946 0
Anxiety symptoms
Timepoint [2] 457946 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [3] 457947 0
Psychological distress
Timepoint [3] 457947 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [4] 457948 0
Mental wellbeing
Timepoint [4] 457948 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [5] 457949 0
Health-related Quality of Life
Timepoint [5] 457949 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [6] 457950 0
Alcohol use
Timepoint [6] 457950 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [7] 457951 0
Vaping
Timepoint [7] 457951 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [8] 457952 0
Substance use
Timepoint [8] 457952 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [9] 457953 0
Help-seeking intention
Timepoint [9] 457953 0
Baseline, 3- and 12-months post-baseline.
Secondary outcome [10] 458719 0
Help-seeking behaviour
Timepoint [10] 458719 0
Baseline, 3- and 12-months post-baseline.

Eligibility
Key inclusion criteria
Eligible participants include Year 9 and Year 10 students attending a participating school in 2027, who have provided active informed consent and opt-out parental consent.

Eligible schools include secondary or combined primary and secondary schools in Australia with school principal permission.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Unable to provide informed consent or opted out by parent or guardian.

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)
Concealed, central randomisation by computer. Schools will be randomly allocated a condition by a member of the research team with no role in school recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using the block-rand function in R, stratifying by school gender mix (coeducational or predominately male/female [>60%]).
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
Sample Size:
The trial is powered to detect intervention by time interactions in longitudinal cluster-RCTs. To achieve 80% power to detect a meaningful effect size (0.2), with an assumed correlation of 0.5, between two intervention conditions across four timepoints, seven schools (n= 420 students) in each condition will be required. To account for school (~20%) and student (~20%) attrition, a total of 18 schools (with at least 1,080 students) will be recruited. This strategy is based on sample size calculations by Heo & Leon (2009) and effect sizes and participation rates of comparable previous prevention trials.

Statistical analysis:
Baseline equivalence will be examined using single-level analyses; ANOVA (normally distributed data); chi-squared tests (binominal data); Mann-Whitney U-tests (non-normally distributed data). Attrition analysis will be performed to examine differences between those who completed at least one follow-up occasion and those who did not.

Primary analyses will follow intention-to-treat approach. Mixed effects linear regression models will be fit with a time x group interaction to evaluate whether receiving the intervention significantly impacted primary outcomes at 3-months post-baseline.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2026
Actual
Date of last participant enrolment
Anticipated
18/12/2026
Actual
Date of last data collection
Anticipated
7/04/2028
Actual
Sample size
Target
1080
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 321185 0
Government body
Name [1] 321185 0
National Health and Medical Research Council (NHMRC)
Country [1] 321185 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 323894 0
None
Name [1] 323894 0
Address [1] 323894 0
Country [1] 323894 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319720 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 319720 0
Ethics committee country [1] 319720 0
Australia
Date submitted for ethics approval [1] 319720 0
19/01/2026
Approval date [1] 319720 0
09/02/2026
Ethics approval number [1] 319720 0

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

Contacts
Principal investigator
Name 148174 0
Dr Louise Birrell
Address 148174 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 148174 0
Australia
Phone 148174 0
+61 2 8627 9048
Fax 148174 0
Email 148174 0
[email protected]
Contact person for public queries
Name 148175 0
Louise Birrell
Address 148175 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 148175 0
Australia
Phone 148175 0
+61 2 8627 9048
Fax 148175 0
Email 148175 0
[email protected]
Contact person for scientific queries
Name 148176 0
Louise Birrell
Address 148176 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 148176 0
Australia
Phone 148176 0
+61 2 8627 9048
Fax 148176 0
Email 148176 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.