Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000873820
Ethics application status
Approved
Date submitted
14/05/2021
Date registered
6/07/2021
Date last updated
16/06/2024
Date data sharing statement initially provided
6/07/2021
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
Scientific title
Mental Health and Wellbeing Coordinators in primary schools to support student mental health: Protocol for a quasi-experimental cluster study
Secondary ID [1] 304191 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health and wellbeing 321879 0
Condition category
Condition code
Mental Health 319606 319606 0 0
Anxiety
Mental Health 319607 319607 0 0
Depression
Mental Health 319608 319608 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 319609 319609 0 0
Other mental health disorders
Mental Health 319610 319610 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. Schools will be selected to participate in the intervention based on assessment by the Victorian Department of Education.

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 Communities of Practice sessions (2 hours) throughout the intervention period which will include a selected expert for each session.

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 will be monitored using various methods as follows: (a) MHWCs will be asked to provide a description of daily tasks at 30-minute intervals over two separate weeks across the year; they will be asked to code the activity using task codes provided, and to record where on the mental health continuum they are working, the stakeholders involved, resources used, and the tier/level of support required; (b) qualitative data collection via separate focus groups with MHWCs and school leaders at T4 and T5 assessing the extent to which core components of the intervention have been implemented; and (c) quantitative data collection at T4 and T5 evaluating implementation of the intervention, including fidelity.
Intervention code [1] 320517 0
Prevention
Intervention code [2] 320518 0
Behaviour
Comparator / control treatment
Business as Usual, ie. schools continue with their standard programs of mental health support
Control group
Active

Outcomes
Primary outcome [1] 327467 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] 327467 0
2 months, 10 months and 17 months post allocation; the primary endpoint is considered to be 10 months post allocation
Secondary outcome [1] 395193 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 [composite secondary outcome]
Timepoint [1] 395193 0
2 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [2] 395194 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] 395194 0
2 months, 3 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [3] 395195 0
Child mental health stigma, as measured by the Attitudes about Child Mental Health Questionnaire (ACMHQ)
Timepoint [3] 395195 0
2 months, 3 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [4] 395196 0
Student mental health and wellbeing, as measured by the SDQ
Timepoint [4] 395196 0
2 months, 3 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [5] 395197 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] 395197 0
6 months and 10 months post allocation
Secondary outcome [6] 395198 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] 395198 0
2 months, 6 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [7] 395199 0
Prioritisation of child mental health & wellbeing within school’s curriculum & planning, as measured by: study designed measures based on Patalay (2017)
Timepoint [7] 395199 0
2 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [8] 395200 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] 395200 0
2 months, 10 months, 17 months, 29 months and 41 months post allocation
Secondary outcome [9] 395201 0
Level of unmet mental health and wellbeing need within classrooms, using study designed measure to capture the number of students in a class who need mental health support but are not receiving sufficient or any support.
Timepoint [9] 395201 0
2 months and 10 months post allocation
Secondary outcome [10] 395202 0
Implementation (feasibility, acceptability, appropriateness, reach, fidelity), as measured by 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 [composite secondary outcome]
Timepoint [10] 395202 0
6 months and 10 months post allocation
Secondary outcome [11] 395203 0
Cost Impacts, as measured by cost inputs (FTE, resources, CRT funding), job analysis and referral activities log, focus group data
Timepoint [11] 395203 0
6 months and 10 months post allocation
Secondary outcome [12] 395204 0
Readiness to Implement, as measured by Readiness to Implement scale
Timepoint [12] 395204 0
2 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
80 Years
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 teacher 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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Non-randomised assignment of schools to intervention or comparison group. Intervention schools will be selected to participate by the Victorian Department of Education and matched control schools will be selected based on the following criteria: school size, locality, and socio-educational profile.
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
9/03/2021
Date of last participant enrolment
Anticipated
23/07/2021
Actual
23/07/2021
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
2912
Accrual to date
Final
1854
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308562 0
Government body
Name [1] 308562 0
Department of Education
Country [1] 308562 0
Australia
Funding source category [2] 308565 0
Charities/Societies/Foundations
Name [2] 308565 0
Ian Potter Foundation
Country [2] 308565 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] 309414 0
University
Name [1] 309414 0
Melbourne Graduate School of Education, University of Melbourne
Address [1] 309414 0
Centre of Program Evaluation, Melbourne Graduate School of Education, 100 Leicester St, Carlton VIC 3053
Country [1] 309414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308504 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 308504 0
Ethics committee country [1] 308504 0
Australia
Date submitted for ethics approval [1] 308504 0
Approval date [1] 308504 0
16/07/2020
Ethics approval number [1] 308504 0
65924
Ethics committee name [2] 308508 0
Victorian Department of Education and Training’s (DET) Research in Schools and Early Childhood settings Ethics Committee (RISEC)
Ethics committee address [2] 308508 0
Ethics committee country [2] 308508 0
Australia
Date submitted for ethics approval [2] 308508 0
Approval date [2] 308508 0
30/09/2020
Ethics approval number [2] 308508 0
2020_004332

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

Contacts
Principal investigator
Name 110938 0
Prof Frank Oberklaid
Address 110938 0
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Rd, Parkville VIC 3052
Country 110938 0
Australia
Phone 110938 0
+61393456141
Fax 110938 0
Email 110938 0
[email protected]
Contact person for public queries
Name 110939 0
Simone Darling
Address 110939 0
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Rd, Parkville VIC 3052
Country 110939 0
Australia
Phone 110939 0
+61 393456141
Fax 110939 0
Email 110939 0
[email protected]
Contact person for scientific queries
Name 110940 0
Jon Quach
Address 110940 0
Melbourne Graduate School of Education
University of Melbourne
110 Leicester St, Carlton VIC 3053
Country 110940 0
Australia
Phone 110940 0
+61383441200
Fax 110940 0
Email 110940 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, contact:
Simone Darling, email: [email protected]
Murdoch Children's Research Institute
Royal Children's Hospital
50 Flemington Road, Parkville, Vic, 3052


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
SourceTitleYear of PublicationDOI
EmbaseMental health and wellbeing coordinators in primary schools to support student mental health: protocol for a quasi-experimental cluster study.2021https://dx.doi.org/10.1186/s12889-021-11467-4
N.B. These documents automatically identified may not have been verified by the study sponsor.