Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12621000137897
Ethics application status
Approved
Date submitted
10/11/2020
Date registered
10/02/2021
Date last updated
31/01/2023
Date data sharing statement initially provided
10/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Youth mental health screening in schools and pathways to care for at-risk students
Scientific title
Development and validation of a universal mental health screening tool and follow-up referral system to identify at-risk students in Australian schools
Secondary ID [1] 302747 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 319683 0
Anxiety 319684 0
ADHD 319685 0
Eating disorders 319686 0
Suicide 319687 0
Self-harm 319688 0
Bullying 319689 0
Condition category
Condition code
Mental Health 317612 317612 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Schools (n=100) from a broad range of social, regional and economic areas will be invited to
participate in the project. Once schools have volunteered to participate, the schools will be randomly assigned to either receive immediate screening (experimental group; n=50) or delayed screening (control group; delayed by 9 months; n=50).

Students in Years 4-11 in the immediate screening group will complete a mental health screening tool, consisting of a series of questions relating to their mental health. The screening tool will be delivered through an online survey system (REDCap) during PDHPE/health class at school (overseen by a health/welfare teacher, with the school psychologist available for additional support at the time of screening, should students need it). This initial screening tool will consist of a large pool of items, taken from a range of standard emotional health questionnaires - Spence Children’s Anxiety Scale (SCAS; Spence, 1998), Child Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013), Personal Experiences Checklist – Short Form (PECK-SF; Prinz, Costa, Chervonsky, & Hunt, 2019), RADAR (Child and Youth versions; Burns & Rapee, 2016, 2019), Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997), Epworth Sleepiness Scale (ESS; Johns, 1991), Adolescent Sleep Hygiene Scale (ASHS; LeBourgeois et al., 2005), Child Health Utility instrument (CHU-9D; Stevens, 2008), and the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 2008).

This screening tool will take approximately 30 minutes for students to complete. Adherence will be monitored by utilising REDCap website analytics that measure survey commencement and completion (partial or total). Ultimately, this large set of items will be reduced to a small set of the best possible items and will form the final brief screener. We envisage that the final brief screener will take no more than 10 minutes for students to complete.

To validate our screening tool, students and parents will be invited to be interviewed by a clinical psychologist using structured diagnostic interviews (the current gold standard for diagnosis of mental health disorders) – we will use the Anxiety Disorders Interview Schedule, Child and Parent version to diagnose anxiety and mood disorders, which will be augmented with the eating disorders section from the KSADS and self-harm items from the Deliberate Self-Harm Inventory. Additionally, parents will be asked to complete an online survey with measures of prior help-seeking, quality of life and attitudes towards acceptability of school screening. We will also ask to access school data on student school attendance and academic performance, as these are known correlates with mental health issues. These will serve as validators to the screening tool so we can assess how accurately our screener identifies at-risk youth. The final brief screener will be developed based on these validators and Item Response Theory analysis.

We will identify those students who score in the “at-risk” range on any measure of emotional health problems as soon as possible after screening and communicate this to schools (for students identified as at-risk of suicide or self-harm, identification and communication to schools will be immediate - within 24 hours). School psychologists and welfare teachers will work with identified students and their families to offer pathways to relevant support services, according to the most accepted and approved processes identified by key stakeholders (students, parents, school staff, mental health clinicians, and policy makers).

Approximately 9 months later, students in the immediate screening group will complete the final brief screener. At this same time, students allocated to the delayed screening group will complete the final brief screener for the first time. This will allow a direct comparison of the emotional health and professional help-seeking between students whose schools had engaged in the screening and pathways to care process (experimental group) and those whose schools had not engaged in the process (control group). Students in the delayed screening group will complete the screener for a second time approximately 6 months later.
Intervention code [1] 319029 0
Early detection / Screening
Intervention code [2] 319030 0
Prevention
Comparator / control treatment
The comparator/control group will consist of 50 schools who will complete only the final brief screening tool, and will complete this 9 months after the experimental group. At the time when students in the delayed screening group complete the screener for the first time, students in the experimental group will be completing the screener for the second time, and students screened as at-risk of emotional disorders will have already been identified and received additional support. This will allow a direct comparison of the emotional health and professional help-seeking between students whose schools had engaged in the screening and pathways to care process (experimental group) and those whose schools had not engaged in the process (control group).

Students in the delayed screening group will complete the screener for a second time approximately 6 months later, so that we can collect post-treatment data for this group.
Control group
Active

Outcomes
Primary outcome [1] 325659 0
Amount of formal help-seeking for mental health problems, assessed by a resource-use questionnaire developed for the current study.
Timepoint [1] 325659 0
For students in the immediate screening condition, this will be measured at the same time as when they first complete the initial mental health screening tool (Timepoint 1a, baseline), then again nine months later (Timepoint 2a, which is the primary timepoint).

For students in the delayed screening condition, this will be measured at the same time as they first complete the mental health screening tool, which equates to the same time as Timepoint 2a for students in the immediate screening condition (Timepoint 1b, baseline). This will be measured again 6 months later (Timepoint 2b, primary timepoint).
Primary outcome [2] 325660 0
Level of emotional distress, measured by our student mental health screening tool (i.e., the survey designed specifically for this study, to be validated).
Timepoint [2] 325660 0
For students in the immediate screening condition, this will be measured when they first complete the initial mental health screening tool (Timepoint 1a, baseline), then again nine months later (Timepoint 2a, which is the primary timepoint).

For students in the delayed screening condition, this will be measured when they first complete the mental health screening tool, which equates to the same time as Timepoint 2a for students in the immediate screening condition (Timepoint 1b, baseline). This will be measured again 6 months later (Timepoint 2b, primary timepoint).
Secondary outcome [1] 388717 0
Quality of life, measured using the Child Health Utility instrument (CHU-9D; Stevens, 2008).
Timepoint [1] 388717 0
For students in the immediate screening condition, this will be measured at the same time as when they first complete the initial mental health screening tool (Timepoint 1a, baseline), then again nine months later (Timepoint 2a).

For students in the delayed screening condition, this will be measured at the same time as they first complete the mental health screening tool, which equates to the same time as Timepoint 2a for students in the immediate screening condition (Timepoint 1b, baseline). This will be measured again 6 months later (Timepoint 2b).
Secondary outcome [2] 389728 0
School attendance for the school year, assessed through school attendance records provided to us by the schools.
Timepoint [2] 389728 0
For students in the immediate screening condition, this will be measured at the same time as when they first complete the initial mental health screening tool (Timepoint 1a, baseline), then again nine months later (Timepoint 2a).

For students in the delayed screening condition, this will be measured at the same time as they first complete the mental health screening tool, which equates to the same time as Timepoint 2a for students in the immediate screening condition (Timepoint 1b, baseline). This will be measured again 6 months later (Timepoint 2b).
Secondary outcome [3] 389729 0
Acceptability of school mental health screening and referral process, assessed through questions developed for this study. Acceptability questions will be answered by students, parents, and school staff.
Timepoint [3] 389729 0
For students in the immediate screening condition, this will be measured at a single timepoint, 9 months after baseline/start of testing.

For students in the delayed screening condition, this will be measured at a single timepoint, 6 months after their baseline, which equates to 15 months after baseline for students in immediate screening condition (start of testing).
Secondary outcome [4] 390592 0
Confidence in identification of emotional disorders among school administrators and staff, as assessed by study-specific questionnaire.
Timepoint [4] 390592 0
For students in the immediate screening condition, this will be measured at a single timepoint, 9 months after baseline/start of testing.

For students in the delayed screening condition, this will be measured at a single timepoint, 6 months after their baseline, which equates to 15 months after baseline for students in immediate screening condition (start of testing).

Eligibility
Key inclusion criteria
For student participants, inclusion criteria are:
* Attendance at a participating school
* Students are in Year 4 through to Year 11

For adult participants (parents and school staff), inclusion criteria are:
* Involvement in a participating school
* Provided opt-in (active) consent to participate
* No age limit applies to adult participants - age limits provided below are for student participants.
Minimum age
9 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Schools will be randomly allocated to either the immediate screening condition (experimental/treatment condition) or the delayed screening condition (control condition; delayed by approx. 9 months). Ultimately, all schools will receive the intervention, but we will compare results in the immediate screening condition after their intervention with results in the delayed screening condition before their intervention (i.e., at baseline) to enable a comparision of treatment vs control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants was derived based on feasibility of school recruitment. The required sample of 100 schools is feasible based on this research team's previous experience in which a previous study with 15 participating schools provided 4,000 students at approx. 260 students per school. Therefore, we have estimated around 25,000 students from 100 schools as a feasible sample size for this trial..

We conservatively estimate data to be collected from around 25% of parents and school staff, approximately 6,250 each, based on previous research using opt-in (active) consent. However, all parents and school staff from participating schools will be invited to participate, so this number may be higher.

Statistical analysis will consist of the following for each component of the study:

i) Primary outcomes
It is predicted that compared against youth in the control (delayed screening) group (at their baseline), students in the experimental (immediate screening) group (at their follow-up) will report a greater amount of formal help-seeking and higher levels of mental health. This hypothesis will be tested by simple pair-wise comparisons depending on the specific measure(s) – i.e., chi-square; t-tests; and multivariate analyses of variance. Students who do not return data will have their data imputed by multiple imputation to allow complete (intention to treat) analysis.

ii) Economic modelling
We will develop an economic model that will evaluate the costs of the screening, downstream cost implications including costs of care provided as a consequence of the screening, as well as potentially longer term cost savings (e.g. reduced productivity costs for parents of children whose emotional symptoms improve). We will also estimate the potential health gains of improved access to care as a consequence to this screening using the information which parents will provide us on the type of care their child is accessing as a consequence of the screening. The challenge of this project design
will be to determine what care parents would have accessed for their children had the screening not been in place. This comparator will be the care accessed by the delayed screening controls – although it is acknowledged that this comparator will not provide a long-term estimate of pathways followed by parents who do not have access to screening. Therefore, the data collected by this study will be augmented by other data sources such as the longitudinal survey of Children and Adolescents (LSAC) as well as the Young Minds Matter Survey, which is the National prevalence surveys of mental health in Australian children and adolescents.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
19/02/2021
Date of last participant enrolment
Anticipated
Actual
23/04/2021
Date of last data collection
Anticipated
Actual
19/11/2022
Sample size
Target
37500
Accrual to date
Final
14323
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307169 0
Charities/Societies/Foundations
Name [1] 307169 0
Bupa Health Foundation
Country [1] 307169 0
Australia
Primary sponsor type
Individual
Name
Ron Rapee
Address
Room 721, 4 First Walk
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 307766 0
Individual
Name [1] 307766 0
Rebecca-Lee Kuhnert
Address [1] 307766 0
Room 726, 4 First Walk
Macquarie University, NSW 2109, Australia
Country [1] 307766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307283 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 307283 0
Ethics committee country [1] 307283 0
Australia
Date submitted for ethics approval [1] 307283 0
30/10/2020
Approval date [1] 307283 0
02/02/2021
Ethics approval number [1] 307283 0
52021918824322

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

Contacts
Principal investigator
Name 106678 0
Prof Ron Rapee
Address 106678 0
Room 721, 4 First Walk
Macquarie University, NSW 2109, Australia
Country 106678 0
Australia
Phone 106678 0
+61 2 9850 8032
Fax 106678 0
Email 106678 0
ron.rapee@mq.edu.au
Contact person for public queries
Name 106679 0
Rebecca-Lee Kuhnert
Address 106679 0
Room 726, 4 First Walk
Macquarie University, NSW 2109, Australia
Country 106679 0
Australia
Phone 106679 0
+61 2 9850 8032
Fax 106679 0
Email 106679 0
rebecca.kuhnert@mq.edu.au
Contact person for scientific queries
Name 106680 0
Rebecca-Lee Kuhnert
Address 106680 0
Room 726, 4 First Walk
Macquarie University, NSW 2109, Australia
Country 106680 0
Australia
Phone 106680 0
+61 2 9850 8032
Fax 106680 0
Email 106680 0
rebecca.kuhnert@mq.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9678Ethical approval  rebecca.kuhnert@mq.edu.au



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.