Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001116718
Ethics application status
Approved
Date submitted
29/07/2022
Date registered
12/08/2022
Date last updated
20/06/2024
Date data sharing statement initially provided
12/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Understanding if mental health and wellbeing coordinators in primary schools can help improve student mental health support: an expanded study
Scientific title
A quasi-experimental cluster study to evaluate the effectiveness of the Mental Health and Wellbeing Coordinator Model in Victorian primary schools: an expanded study
Secondary ID [1] 307457 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is an expansion of ACTRN12621000873820.

Health condition
Health condition(s) or problem(s) studied:
Mental health and wellbeing 326841 0
Condition category
Condition code
Mental Health 324050 324050 0 0
Anxiety
Mental Health 324051 324051 0 0
Depression
Mental Health 324052 324052 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 324053 324053 0 0
Other mental health disorders
Mental Health 324054 324054 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of the Mental Health and Wellbeing Coordinator (MHWC) role and related training program.

The MHWC role: Intervention schools will receive funding from the Victorian Department of Education and Training to employ a mental health and wellbeing coordinator (MHWC) at a full-time equivalency. Each school will recruit or appoint a teacher to the MHWC position. Once recruited the MHWC will:
1. Receive evidence-based training around supporting the mental health needs of primary school students;
2. Embed evidence-based training (Tier 1 practices & frameworks) across the school and build the capability of teaching and education support staff to better identify and support students with mental health concerns;
3. Be a significant contributor to the school’s wellbeing team;
4. Support the referral pathway for students identified as requiring further assessment and intervention within the school or to external community-based services (the MHWC role will not involve providing 1:1 counselling support to students);
5. Work proactively with regional staff (i.e., psychologists, speech and language therapists, social workers), school wellbeing and leadership teams, and other health professionals (community-based psychologists, paediatricians, GPs, other allied health) to engage appropriate mental health support such as assessment, counselling, classroom based adjustments;
6. Connect wellbeing initiatives across the school and be responsible for implementing whole school approaches to mental health and wellbeing, including the social and emotional learning curriculum.

MHWC full time equivalency (FTE) allocation will be determined based on number of student enrolments at each school using the following scale: 0-149 students = 0.4 FTE, 150-299 students=0.6 FTE, 300-449 students=0.8 FTE, >449 students=1.0 FTE. An additional loading will be applied to regional and rural schools.

The MHWC Training Program: The MHWC will participate in a purpose designed training program, delivered by the research team at the Melbourne Graduate School of Education (University of Melbourne), to build knowledge, skills, and attitudes to effectively focus on building the capacity of the whole school, working with individual teachers and the whole staff cohort. The training comprises an induction session followed by three core modules: (1) Mental Health Literacy, (2) Supporting Need and (3) Building Capacity. MHWCs will receive all core modules, and up to three nominated school trainees from each participating school will receive components of the training. MHWCs will also attend monthly Community of Practice sessions (2 hours) throughout the intervention period which will include a selected expert for each session. For the 2022 expanded study, MHWCs will also be assigned to a 'Learning Leader' who will facilitate the Community of Practice sessions for a particular cluster of schools and be available for learning and development support and coaching throughout the intervention period. The learning leader is a member of the research and training team, delivering the intervention. The learning leader is assigned to a subset (or ‘cluster’) of schools based on geographic location. Up to two x 30 minute support/coaching ‘drop-in’ sessions are offered per week and are delivered via video-conference. Mental Health and Wellbeing Coordinators can link in to as many or as few sessions as they wish and discuss any issues related to their role.

Content of the core modules will focus on the following broad areas:
• Mental health and wellbeing as a continuum, including behavioural, social emotional and learning indicators.
• Risk and protective factors for mental health concerns and promoting wellbeing.
• Engaging parents and carers and supporting school staff in conversations with parents and carers about student mental health and wellbeing.
• Building and maintaining effective relationships with service providers.
• Understanding the referral pathways within the school system and into the community.
• Evidence-based prevention and promotion activities and programs and evaluating their effectiveness and fit for purpose in the school context.

The instruction will use a problem/task centred approach informed by Merrill’s first principles of instruction (Merrill, 2002). These principles work on the basis that learning is promoted when: learners acquire knowledge in the context of real-world problems; existing knowledge is activated as a foundation for new knowledge; new knowledge is demonstrated to the learner, applied by the learner, and integrated into the learner’s world. MHWCs and other school participants will practice applying their knowledge through case studies, role-plays, and case studies and examples from their school context. Outputs of the training include a mental health and wellbeing profile and plan; and care pathway mapping based on each participant’s individual school context and circumstances.

The majority of content will be delivered over an intensive 3-day training program via a synchronous online environment, using teleconference technology to facilitate the building of professional networks and communities of practice. In addition, asynchronous learning including, videos, content-based activities, pre-reading, skills and knowledge checks, completion of online modules from other providers (as pre-requisites to cover basic concepts and engage with potential resources for staff professional development) and reviewing previously covered material to consolidate learning. Communities of practice and skills practice ‘on-the-job’ will also form an integral part of the learning approach and will continue as part of the model once the training is complete.

Adherence to the intervention is monitored via the following:
• Job Analysis Tool: To evaluate the tasks, responsibilities, time and resources required to achieve all aspects of the MHWC role and successful implementation of the MHWC model, MHWC activity will be recorded in two study developed databases (“Job Analysis Tool” [JAT] & “Care Pathway Tool” [CPT]). Information collected from both these tools will include the number of students referred for additional support, number of interactions with classroom teachers, time spent on tasks, type of mental health and wellbeing activities the MHWC is assisting with, number of referrals made, uptake/outcome of referral, waitlist times and number and type of interactions with regional staff.
• Survey data: survey data includes study-devised questions about implementation including how much time the MHWC is committing to the various aspects of the role and how much time, if any, they are spending on activities unrelated to their role.

The intervention period commences at the start of the school year when the MHWC commences in the role, and continues for 24 months; after which the MHWC will continue in their role without direct support from the research and training team.

The 74 primary schools delivering the MHWC model were identified by the Victorian Department of Education and Training (DET) from the NWVR (North-East Melbourne, Mallee, Hume Moreland and Loddon Campaspe areas), and SWVR (Barwon, Wimmera South West, Central Highlands, Brimbank Melton and Western Melbourne areas). Schools were recruited by DET based on mental health need (through consultation with regional stakeholders and Incident Reporting Information System [IRIS] data), readiness (ensuring schools have the capacity and willingness to participate) and context diversity (including metropolitan, regional and rural contexts, and those impacted to different degrees by COVID-19). In addition, 2 Specialist Schools and 1 English as an Additional Language (EAL) school were included amongst the schools recruited in 2022.

The 35 BAU schools were recruited by invitation from MCRI sent to selected primary schools in the NWVR and SWVR. BAU schools were selected based on matching characteristics with intervention schools, including socio-demographic characteristics (ie. ICSEA), school size (ie. number of enrolments) and location (ie. metropolitan/regional/rural).

Between 2023 – 2026 the MHWC model is rolling out to all Victorian government and low-fee non-government primary schools. This includes schools that were previously recruited as BAU (‘control') schools. Therefore, over the next four years, the number of BAU schools will decrease from 35 in 2022, to 26 in 2023, 19 in 2024, 9 in 2025 and 0 in 2026.
Intervention code [1] 323910 0
Prevention
Intervention code [2] 323911 0
Behaviour
Comparator / control treatment
Business as Usual (BAU) schools. These schools will not be involved in delivering the MHWC model. Any mental health support already offered within the school can continue.
Control group
Active

Outcomes
Primary outcome [1] 331841 0
Teacher confidence to support student mental health and wellbeing, as measured by the Student Mental Health Self-efficacy Teacher Survey (SMH-SETS)
Timepoint [1] 331841 0
2 months, 10 months and 17 months post allocation: the primary endpoint is considered to be 10 months post allocation
Secondary outcome [1] 411350 0
Perceived levels of support in managing child mental health, as measured by: study designed measures based on Patalay (2017); Victorian Department of Education Attitudes to School Survey and Parenting Opinion Survey
Timepoint [1] 411350 0
2 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [2] 411351 0
Mental health literacy, as measured by: Child Health Poll (Royal Children's Hospital, 2017) and study designed measures and vignettes aimed at capturing level of skill and confidence in identifying and managing child mental health and wellbeing [composite secondary outcome]
Timepoint [2] 411351 0
2 months, 3 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [3] 411352 0
Child mental health stigma, based on the Attitudes about Child Mental Health Questionnaire (ACMHQ)
Timepoint [3] 411352 0
2 months, 3 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [4] 411353 0
Student mental health and wellbeing, as measured by the Strengths and Difficulties Questionnaire (SDQ).
Timepoint [4] 411353 0
2 months, 3 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [5] 411354 0
Levels of engagement with MHWC, using study designed measure designed to capture the perceived level of engagement required, the actual level of engagement, and the types of support provided to staff by the MHWC.
Timepoint [5] 411354 0
6 months and 10 months post allocation
Secondary outcome [6] 411355 0
Levels of engagement with DET-based and externally based mental health and wellbeing services, as measured by: study designed measures based on Patalay (2017); Victorian Department of Education Attitudes to School Survey and Parenting Opinion Survey [composite secondary outcome]
Timepoint [6] 411355 0
2 months, 6 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [7] 411356 0
Prioritisation of child mental health & wellbeing within school’s curriculum & planning, as measured by: study designed measures based on Patalay (2017)
Timepoint [7] 411356 0
2 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [8] 411357 0
School engagement and perceived mental health support, as measured by: study designed measures based on Patalay (2017); Victorian Department of Education Attitudes to School Survey and Parenting Opinion Survey [composite secondary outcome]
Timepoint [8] 411357 0
2 months, 10 months, 17 months and 29 months post allocation
Secondary outcome [9] 411358 0
Level of unmet mental health and wellbeing need within classrooms, using study designed measures to capture the number of students in a class who need mental health support but are not receiving sufficient or any support.
Timepoint [9] 411358 0
2 months and 10 months post allocation
Secondary outcome [10] 411359 0
Implementation (feasibility, acceptability, appropriateness, reach, fidelity), as measured by a composite of the Acceptability of Intervention Measure, Intervention appropriateness measure, Feasibility of Intervention measure, study designed Referral Activities log and job analysis, training feedback data, focus group data. Audio-recorded focus groups will be run by an experienced qualitative researcher, using a semi-structured interview guide.
Timepoint [10] 411359 0
6 months and 10 months post allocation
Secondary outcome [11] 411360 0
Cost Impacts, as measured by a composite of cost inputs (FTE, resources, CRT funding), job analysis and referral activities log, focus group data, service use data. Audio-recorded focus groups will be run by an experienced qualitative researcher, using a semi-structured interview guide.
Timepoint [11] 411360 0
2 months, 6 months, 10 months and 17 months post allocation
Secondary outcome [12] 411361 0
Readiness to Implement, as measured by Readiness to Implement scale. The readiness measures are based primarily on the work of Bliss & Wanless (2018).
Timepoint [12] 411361 0
2 months and 6 months post allocation

Eligibility
Key inclusion criteria
Schools: Primary schools in North West and South West Department of Education regions, Victoria, Australia.
MHWC and training participants: Teaching qualification and registration with the Victorian Institute of Teaching
School staff survey: Classroom teachers, school leaders (Principals, Assistant Principals, Leading teachers & Wellbeing staff), and education support staff
Years 2 and 4 classroom teachers: Teaching year 2 and/or 4 students
Parents / Carers: Primary caregiver of year 2 or 4 student
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools: Secondary schools (ages 12-20), specialist schools (i.e., schools teaching specialist subjects or specialise teaching students with disability), and schools located outside north-west , and south-west Department of Education regions of Victoria were excluded from the study
MHWC and training: administrative staff
School staff surveys: administrative staff
Year 2 and 4 teachers: Does not teach year 2 or 4
Parents / Carers: Not primary caregiver of student in year 2 or 4

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Non-randomised assignment of schools to intervention or comparison group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All participants with available data will be analysed. We will make every attempt to ensure that data are not missing from surveys at the point of completion. If there are missing responses to surveys completed by school or regional staff we will follow up via phone or email up to three times to obtain the missing responses. If the amount of missing data is large, we will conduct a sensitivity analysis using multiple imputation to accommodate for the missing data.

The primary outcome (mean difference in School Mental Health Self-efficacy Teacher Survey (SMH-SETS) total score at 10 months) will be analysed using mixed effects linear regression fitted at the teacher level, including a fixed effect for arm (MHWC vs. BAU) and a random effect for school, adjusting for baseline values of SMH-SETS and school matching criteria (ICSEA, number of enrolments and metro/regional/rural location).

According to the nature of the secondary outcomes to be analysed (binary, continuous or ordinal) the appropriate mixed effects model will be used to estimate the impact of the MHWC model on the outcome of interest compared to the BAU schools. These models will be fitted at the participant level, including a fixed effect for arm (MHWC vs. BAU) and a random effect for school adjusting for school matching criteria (ICSEA, number of enrolments and metro/regional/rural location) and baseline value of the outcome where available.

For qualitative focus groups - they will be analysed using Braun and Clarkes five stages of thematic analysis and will be reported in line with the COREQ checklist.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
7/02/2022
Date of last participant enrolment
Anticipated
Actual
24/06/2022
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
8020
Accrual to date
Final
6082
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311728 0
Government body
Name [1] 311728 0
Department of Education
Country [1] 311728 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
Royal Children's Hospital, 50 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 313188 0
University
Name [1] 313188 0
Melbourne Graduate School of Education, University of Melbourne
Address [1] 313188 0
Centre of Program Evaluation, Melbourne Graduate School of Education, 100 Leicester St, Carlton VIC 3053
Country [1] 313188 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311176 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 311176 0
Ethics committee country [1] 311176 0
Australia
Date submitted for ethics approval [1] 311176 0
Approval date [1] 311176 0
16/07/2020
Ethics approval number [1] 311176 0
65924
Ethics committee name [2] 311178 0
Victorian Department of Education and Training’s (DET) Research in Schools and Early Childhood settings Ethics Committee (RISEC)
Ethics committee address [2] 311178 0
Ethics committee country [2] 311178 0
Australia
Date submitted for ethics approval [2] 311178 0
Approval date [2] 311178 0
30/09/2020
Ethics approval number [2] 311178 0
2020_004332
Ethics committee name [3] 311362 0
Melbourne Archdiocese Catholic Schools
Ethics committee address [3] 311362 0
Ethics committee country [3] 311362 0
Australia
Date submitted for ethics approval [3] 311362 0
Approval date [3] 311362 0
09/12/2021
Ethics approval number [3] 311362 0
Ethics committee name [4] 311363 0
Catholic Diocese of Ballarat
Ethics committee address [4] 311363 0
Ethics committee country [4] 311363 0
Australia
Date submitted for ethics approval [4] 311363 0
Approval date [4] 311363 0
23/11/2021
Ethics approval number [4] 311363 0
Ethics committee name [5] 311364 0
Catholic Education Sandhurst
Ethics committee address [5] 311364 0
Ethics committee country [5] 311364 0
Australia
Date submitted for ethics approval [5] 311364 0
Approval date [5] 311364 0
15/11/2021
Ethics approval number [5] 311364 0

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

Contacts
Principal investigator
Name 120222 0
Prof Frank Oberklaid
Address 120222 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 120222 0
Australia
Phone 120222 0
+61393456141
Fax 120222 0
Email 120222 0
[email protected]
Contact person for public queries
Name 120223 0
Rachel Smith
Address 120223 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 120223 0
Australia
Phone 120223 0
+61393454521
Fax 120223 0
Email 120223 0
[email protected]
Contact person for scientific queries
Name 120224 0
Simone Darling
Address 120224 0
Murdoch Children's Research Institute, 50 Flemington Rd, Parkville VIC 3052
Country 120224 0
Australia
Phone 120224 0
+61399366687
Fax 120224 0
Email 120224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Researchers who have ethics approval through the Royal Children's Hospital HREC to conduct secondary data analysis
Available for what types of analyses?
As approved by Royal Children's Hospital HREC
How or where can data be obtained?
Direct contact with the study team via [email protected]


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.