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Trial registered on ANZCTR


Registration number
ACTRN12620000753954
Ethics application status
Approved
Date submitted
7/05/2020
Date registered
21/07/2020
Date last updated
21/07/2020
Date data sharing statement initially provided
21/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Mind Your Mate Study: A randomised controlled trial of an online peer intervention to prevent mental health and substance use problems in adolescents
Scientific title
Mind Your Mate: A randomized controlled trial of an online peer support mobile app for adolescent mental health and substance use
Secondary ID [1] 301165 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 317290 0
Alcohol and other substance use 317291 0
Condition category
Condition code
Mental Health 315410 315410 0 0
Anxiety
Mental Health 315411 315411 0 0
Depression
Public Health 315412 315412 0 0
Health promotion/education
Mental Health 315686 315686 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mind your Mate is a school-based intervention aimed at preventing mental health and substance use problems in adolescents. Participating secondary schools will be randomly allocated to one of two groups. One group will serve as the control group and receive their usual Year 9 health education and the other group with receive the Mind your Mate intervention.

Schools allocated to the Mind your Mate intervention will introduce the intervention program in Term 3 or Term 4, 2020. The Mind Your Mate intervention will include one introductory classroom lesson, led by a teacher but delivered online, plus a downloadable mobile application (app).

Teachers are not required to attend training to provide the lesson. This lesson provides teachers with evidence-based teaching material which requires minimal to no preparation, and curriculum-consistent content which maps onto the Australian Curriculum focus areas of alcohol and other drugs and mental health and wellbeing.

The teacher will instruct students to watch a short introductory video through the study website. The introductory video is designed specifically for this study by CI Birrell and will be housed on the study website. This video will cover common mental health problems and introduce the concept of supporting peers and encouraging help-seeking. This may be viewed individually by students on their computers or shown to the class as a whole. The video will be followed by brief student activities such as, group discussions, quizzes and individual worksheets. All materials will be accessible on the study website. Participating students in the intervention condition will then be required to download the app onto their mobile device and use it over the following 12-month period.

The Mind your Mate app is a smartphone application ‘app’ grounded in and fostering the principal of peer support. The program facilitates discussions between friends and provides communication tools to engage in conversations about mental health and substance use so that young people can better support their friends and encourage them to seek professional support where appropriate for mental health and substance use issues.

Participating students are expected to interact with the app through self-directed learning in online modules within the smartphone application, participation in suggested activities, and self-care tasks over a 12-month period.

The online modules include; Mental Health, Stressful Times, Alcohol and Drugs, Listen Up, Keeping Friends Safe, Tricky Conversations, Checking In, What’s Next, Support Options and Looking After Yourself. The modules include information, videos and examples.

Some suggested activities include scheduling future conversations with friends, sending messages to friends using templates, engaging in quizzes in the app, and entering their mood into a mood rating calendar.

Self-care tasks are suggested such as drawing or painting, playing an instrument, and playing sport. Participants can add their own self-care activities.

Participant engagement and adherence to the app will be monitored using app analytics, specifically, general tracking, time and date the app is accessed, length of time the app is accessed for, time spent on page, module start and complete dates, the number of conversations scheduled, the number of friends registered, and the number of activities accessed.

A a number of engagement strategies will be employed to encourage adherence to the app including push notifications, the ability to create avatars and personalise the app, the use videos, personal case studies and interactive elements to enhance engagement with the app.
Intervention code [1] 317470 0
Prevention
Intervention code [2] 317471 0
Behaviour
Intervention code [3] 317472 0
Lifestyle
Comparator / control treatment
Control schools will implement health education as usual in 2020. The Year 9 Health and Physical Education curriculum mandates that alcohol and other drugs and wellbeing content be implemented. As such, all control schools will implement curriculum-based health education during the trial. Control schools will be offered the use of the intervention at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 323659 0
App Specific Mental health and Substance use knowledge.

This is a composite primary outcome that assesses content contained in the mobile application and has been developed by CI Birrell. The scale measuring this outcome contains both app specific mental health knowledge, and app specific substance use knowledge.


Timepoint [1] 323659 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12-months.
Primary outcome [2] 323660 0
Mental Health Literacy

Mental Health Literacy will be measured using questions adapted from The Mental Health Literacy Questionnaire [MHLQ].
Timepoint [2] 323660 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12-months.
Primary outcome [3] 323661 0
Frequency of alcohol consumption.

These questions were originally adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index and reflect those used in previous trials the team has led.
Timepoint [3] 323661 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12-months.
Secondary outcome [1] 382518 0
This is a primary outcome. Other Substance Use - Intention to try substances.

Intention to try drugs will be assessed using questions adapted from the Australian Institute of Health and Welfare: National Drug Strategy Household Survey report, in drug statistics.
Timepoint [1] 382518 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [2] 382521 0
This is a primary outcome. General help-seeking behaviour

General help-seeking behaviour will be measured by the ‘General Help-Seeking Questionnaire’ [GHSQ].

Timepoint [2] 382521 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [3] 382522 0
This is a primary outcome. Actual help-seeking behaviour

Actual help-seeking behaviour will be measured by the ‘Actual Help-Seeking Questionnaire’ [AHSQ], and by questions adapted from The Mission Australia Report, 2018
Timepoint [3] 382522 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [4] 382523 0
This is a primary outcome. Motives for not drinking.

The ‘Motives for Abstaining from Alcohol Questionnaire’ [MAAQ] will be used to assess reasons for not drinking alcohol.
Timepoint [4] 382523 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [5] 383477 0
This is a primary outcome. Psychological Distress.

Psychological distress in the past month will be measured using the ‘Kessler 6’ scale [K6].
Timepoint [5] 383477 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [6] 384160 0
This is a primary outcome. Depression Symptoms.

Depression symptoms will be measured using Patient Health Questionnaire 8’ [PHQ-A]
Timepoint [6] 384160 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [7] 384161 0
This is a primary outcome. Anxiety Symptoms

Anxiety Symptoms will be measured by the ‘Generalised Anxiety Disorder 7-item scale’ [GAD-7].
Timepoint [7] 384161 0
Measured at baseline, and 6- and 12-months post intervention. The primary timepoint is 12 months.
Secondary outcome [8] 384162 0
Positive wellbeing.

The impact of the intervention on positive wellbeing will be assessed using measures adapted from the ‘Warwick-Edinburgh Mental Well-being Scale’ [WEMWBS].
Timepoint [8] 384162 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [9] 384163 0
Quality of Life.

To enable economic modelling of the intervention, the ‘Paediatric Quality of Life’ [CHU-9D) will be used.
Timepoint [9] 384163 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [10] 384164 0
Impact of COVID-19 (coronavirus).

The impact of the COVID-19 pandemic on physical and mental health will be assessed using measures adapted from the Australian National COVID-19 (new Coronavirus) Mental Health, Behaviour and Risk Communication Survey.
Timepoint [10] 384164 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [11] 384165 0
Quantity of alcohol consumption.

The quantity of alcohol consumption in standard drinks will be assessed using questions originally adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index which reflect those used in previous trials the team has led.
Timepoint [11] 384165 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [12] 384166 0
Age of first alcohol consumption.

Assessed using questions originally adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index which reflect those used in previous trials the team has led.
Timepoint [12] 384166 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [13] 384167 0
Proportion of friends who drink.

Assessed using questions originally adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index which reflect those used in previous trials the team has led.
Timepoint [13] 384167 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [14] 384168 0
Intention to try alcohol.

Assessed using questions originally adapted from the School Health and Alcohol Harm Reduction Project ‘Patterns of Alcohol’ index which reflect those used in previous trials the team has led.
Timepoint [14] 384168 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [15] 384169 0
Lifetime drug use.

A yes/no question of whether the participant has tried a certain drug will be assessed using questions adapted from the Australian Institute of Health and Welfare: National Drug Strategy Household Survey report, in drug statistics.
Timepoint [15] 384169 0
Measured at baseline, and 6- and 12-months post intervention.
Secondary outcome [16] 384170 0
Proportion of friends who use drugs

This will be assessed using questions adapted from the Australian Institute of Health and Welfare: National Drug Strategy Household Survey report, in drug statistics.
Timepoint [16] 384170 0
Measured at baseline, and 6- and 12-months post intervention.

Eligibility
Key inclusion criteria
Year 9 students attending participating schools in 2020
Active parental consent received
Active student consent provided
Minimum age
12 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who do not own a smartphone

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 by central randomisation by computer.. Schools will be randomly allocated to groups by an external researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following school recruitment, randomisation will be conducted by an external researcher using the Blockrand function in R. Half of the schools will be randomly allocated to the Mind your Mate intervention condition, and half to an active control group (Year 9 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
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations:

This trial is powered to detect intervention by time interactions in longitudinal cluster randomized clinical trials. To allow for comparisons between the two conditions, 6 schools (of at least 100 students) in each of the 2 intervention groups are required, giving a total of 12 schools (with at least 1,200 students). This would achieve 80% power to detect a standardized between-group mean difference of 0.15 (p =.05) in outcomes at the end of the trial with 3 measurement occasions. An effect size of 0.15 is comparable to previous trials of anxiety, depression and substance use prevention programs and would have substantial benefits on a population level based on economic modelling. To account for school dropouts during the trial, which are expected to be approximately 10% based on similar previous school-based trails, this study will recruit 14 schools (with at least 1,400 students).

Statistical analysis:
Baseline equivalence and attrition between groups will be examined using single-level analyses; one-way analyses of variance to examine normally distributed data, chi-squared analyses to examine binominal data, and Mann-Whitney U-tests to examine non-normally distributed data. To examine intervention by time interaction effects, mixed effects regression will be used due to the multi-level nature of the data (students nested within schools). Hypothesised intervention effects on substance use, anxiety and depression symptoms will primarily be examined using mixed effects linear regression analysis for normally distributed data and mixed effects logistic regression analysis for categorical data. Strategies will be used (multiple imputation and regression weighting) to examine the impact of attrition. Sensitivity analyses will be used to assess the effect of attrition on inferences drawn from target parameters in statistical analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 30181 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 305609 0
Charities/Societies/Foundations
Name [1] 305609 0
Australian Rotary Health
Address [1] 305609 0
43 Hunter Street
Parramatta NSW 2150
Australia
Country [1] 305609 0
Australia
Funding source category [2] 305621 0
University
Name [2] 305621 0
The Brain and Mind Centre, The University of Sydney
Address [2] 305621 0
94 Mallett St, Camperdown NSW 2050
Country [2] 305621 0
Australia
Primary sponsor type
Individual
Name
Dr Louise Birrell
Address
The Matilda Centre for Research in Mental Health and Substance Use,
Level 6, Jane Foss Russell Building, G02, Camperdown NSW 2006,
The University of Sydney
Country
Australia
Secondary sponsor category [1] 306021 0
University
Name [1] 306021 0
The University of Sydney
Address [1] 306021 0
The University of Sydney, Camperdown NSW 2006
Country [1] 306021 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305905 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 305905 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
Camperdown, NSW 2006 Australia
Ethics committee country [1] 305905 0
Australia
Date submitted for ethics approval [1] 305905 0
24/01/2020
Approval date [1] 305905 0
26/03/2020
Ethics approval number [1] 305905 0
2020/054

Summary
Brief summary
Anxiety, mood and substance use disorders have significant social and economic impacts, largely attributable to their early age of onset and chronic disabling course. It is therefore critical to intervene early to prevent these chronic and debilitating trajectories. This project is a world-first effectiveness trial of an online peer intervention (Mind Your Mate) to prevent mental health (focusing on anxiety and depression) and substance use problems in adolescence. It is hypothesised that compared to students in the control condition, those allocated to receive the peer intervention will show significantly lower symptoms of anxiety, depression and substance use, and an increased willingness to seek help for these problems. The online peer intervention includes one introductory classroom lesson, plus a downloadable mobile application (app) that will be used for the duration of 12 months. A CONSORT compliant randomised controlled trial (RCT) of the peer intervention will be conducted with all students in Year 9 in 14 NSW high-schools, with approximately 1,400 students (n=100 students per grade, per school). Schools will be randomly allocated to receive; 1) the online peer intervention, or 2) waitlist control (health education as usual). Students will be followed-up for one year, with assessments at baseline, and 6- and 12-months.
Trial website
https://www.mindyourmate.org/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102010 0
Dr Louise Birrell
Address 102010 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 102010 0
Australia
Phone 102010 0
+61 2 8627 9003
Fax 102010 0
Email 102010 0
louise.birrell@sydney.edu.au
Contact person for public queries
Name 102011 0
Dr Louise Birrell
Address 102011 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 102011 0
Australia
Phone 102011 0
+61 2 8627 9003
Fax 102011 0
Email 102011 0
louise.birrell@sydney.edu.au
Contact person for scientific queries
Name 102012 0
Dr Louise Birrell
Address 102012 0
Level 6, Jane Foss Russell building (G02) University of Sydney, Camperdown, NSW 2006
Country 102012 0
Australia
Phone 102012 0
+61 2 8627 9003
Fax 102012 0
Email 102012 0
louise.birrell@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
All data will be de-identified and aggregated at the school level. IPD will not be available.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7849 0
Study protocol
Citation [1] 7849 0
Link [1] 7849 0
Email [1] 7849 0
louise.birrell@sydney.edu.au
Other [1] 7849 0
Attachment [1] 7849 0
Type [2] 7850 0
Ethical approval
Citation [2] 7850 0
Link [2] 7850 0
Email [2] 7850 0
louise.birrell@sydney.edu.au
Other [2] 7850 0
Attachment [2] 7850 0
Type [3] 7851 0
Informed consent form
Citation [3] 7851 0
Link [3] 7851 0
Email [3] 7851 0
louise.birrell@sydney.edu.au
Other [3] 7851 0
Attachment [3] 7851 0
Type [4] 7852 0
Statistical analysis plan
Citation [4] 7852 0
Link [4] 7852 0
Email [4] 7852 0
louise.birrell@sydney.edu.au
Other [4] 7852 0
Attachment [4] 7852 0
Summary results
No Results