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Trial registered on ANZCTR


Registration number
ACTRN12622001114730
Ethics application status
Approved
Date submitted
5/08/2022
Date registered
12/08/2022
Date last updated
9/02/2024
Date data sharing statement initially provided
12/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Online Mental Health Check and Mental Health Stigma for Primary School Children
Scientific title
Evaluating Access to Care for Australian Children – The Online Mental Health Check: Two School Based Randomised Controlled Trials
Secondary ID [1] 307698 0
Nil known
Universal Trial Number (UTN)
Trial acronym
OMHC (Online Mental Health Check)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 327248 0
Condition category
Condition code
Mental Health 324390 324390 0 0
Anxiety
Mental Health 324391 324391 0 0
Depression
Public Health 324436 324436 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The mental health check is a questionnaire delivered on a website that offers a way for parents and children to answer questions on symptoms of anxiety and depression. This study will aim to evaluate whether the mental health check alone significantly impacts stigma in children aged 6 to 12 years.

The study design is a school-based study where we aim to conduct a cluster randomized controlled trial with two intervention arms. Data will be collected during a baseline assessment and follow up assessments at 6 and 12 weeks. Parent and child report data will be collected using online questionnaires. Data collection at baseline, and 6- and 12-week follow-up assessments will occur online via a website that parents can complete in the comfort of their own home on their own device (e.g., tablet, phone, laptop, computer). Children will complete assessments in their classroom on a school device.

Monitor vs. Control. The key difference in this trial is whether the assessment of stigma is completed before or after the mental health check (the monitor group will complete the stigma assessment after completing the mental health check).
Participants (students and their parents) will be asked to complete the Online Mental Health Check and outcome assessment (stigma only) at baseline, 6 weeks and 12 weeks. Students will be given class time during school hours to complete this, and parents can complete this at a time and place of their choosing. Adherence to completion of the assessments will be monitored by the participating school (for students) and via Qualtrics reports (parents). The questionnaires should take approximately 15-20 minutes to complete.
Intervention code [1] 324175 0
Behaviour
Intervention code [2] 324176 0
Early detection / Screening
Comparator / control treatment
Participants will complete the same Online Mental Health Check and outcome assessments as the intervention group, but the order of the assessments will differ, i.e., participants will complete the outcome assessment (stigma) before completing the mental health check at baseline and 12-week follow-up. Participants in this control group will not be asked to complete the mental health check at 6 week follow-up.
Control group
Active

Outcomes
Primary outcome [1] 332197 0
Mental health stigma as assessed by stigma questionnaires: Child stigma – 1) The Paediatric Self Stigma Scale (PaedS; Kaushik et al., 2017), and Parent stigma – 2) The Generalised Anxiety Stigma Scale (GASS; Griffiths; 2011).
Timepoint [1] 332197 0
Baseline, 6-week follow-up, 12-week follow-up (end point).
Secondary outcome [1] 412518 0
Nil
Timepoint [1] 412518 0
Nil

Eligibility
Key inclusion criteria
• Schools: mainstream Government or Independent primary schools in Australia with the capacity to provide children with a device (i.e., laptop, desktop, tablet) to complete the assessments
• Classes: where schools have more than one Year class, all Year classes will be invited to participate. Classes will range from 15 to 35 students per class and will include a mix of co-ed and single sex schools from both rural and non-rural areas.
• Children: child attends Government or Independent Primary School in Australia and is in Year 3 to 6 with the capacity to answer questions online via a device (i.e., laptop, desktop, tablet), can consent and complete questions online (with help if needed), and their parent/carer has not opted-out
• Parents/carers: Parents of children in Year K to 6 who attends Government or Independent Primary School in Australia, has the capacity to answer questions online via a device (i.e., laptop, desktop, tablet) and complete questions online (with help if needed), and is able to provide informed consent.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children in Year K to 2: Do not have sufficient cognitive capacity to independently answer the check or outcome assessments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by statistics consultant external to the research team
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation/stratification using a randomisation table in Excel
A minimization approach will be used to ensure balance across the conditions (i.e., triage or standard care; monitor or control) on the following variables: 1) socioeconomic status of the school using the Index of Community Socio-Educational Advantage level (ICSEA; <1000 versus => 1000), 2) location of the school (metropolitan vs rural/remote), and 3) gender mix of school (single vs mixed gender schools).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be conducted using IBM SPSS statistics 28. Participant characteristics and scores on outcome measures (stigma) at each time point (baseline, 6 weeks, 12 weeks) will be presented using descriptive statistics: mean, standard deviation, and 95% confidence intervals.
To investigate within group changes in the monitor group from baseline to 6 weeks to 12 weeks, mixed-model repeated measures (MMRM) with effects attributable to schools included as a random intercept will be used for the outcome measure (stigma). Time will be treated as a within-groups factor (baseline, 6 weeks, 12 weeks) and condition as the between-group factor (intervention vs. control). This approach handles missing data by including all available data from each subject into the analysis and assumes missing data are missing at random. An unstructured covariance matrix accommodated within-participant dependency and degrees of freedom will be estimated using the Kenward-Roger method. Between-groups effect sizes will be calculated as the modelled standardized mean difference at each occasion of measurement. All analyses will be two tailed, with statistical significance set at p < .05. Effect sizes will be calculated to determine the size of the within group changes between baseline, 6 weeks, and 12 weeks of the intervention for each outcome measure.
Interim analyses with the Data Safety Monitoring Board will be conducted when 50% target sample has been recruited for each trial.
To investigate between group differences in changes in clinical outcomes from baseline to 6 weeks to 12 weeks in the monitor group compared to the control group, mixed-model repeated measures (MMRM) will then be used to evaluate differences in stigma between the groups. We will include school as a random effect to accommodate clustering effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2022
Actual
6/09/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
7/10/2022
Date of last data collection
Anticipated
31/01/2023
Actual
13/12/2022
Sample size
Target
440
Accrual to date
Final
934
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311967 0
Charities/Societies/Foundations
Name [1] 311967 0
Johnston Foundation
Country [1] 311967 0
Australia
Funding source category [2] 315798 0
Charities/Societies/Foundations
Name [2] 315798 0
AMP Foundation Limited (as trustee for AMP Foundation Trust)
Country [2] 315798 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, High St. Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 313477 0
None
Name [1] 313477 0
Address [1] 313477 0
Country [1] 313477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311396 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 311396 0
Ethics committee country [1] 311396 0
Australia
Date submitted for ethics approval [1] 311396 0
23/05/2022
Approval date [1] 311396 0
05/07/2022
Ethics approval number [1] 311396 0
HC220332

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

Contacts
Principal investigator
Name 120946 0
Prof Jennie Hudson
Address 120946 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120946 0
Australia
Phone 120946 0
+61 2 9065 9251
Fax 120946 0
Email 120946 0
[email protected]
Contact person for public queries
Name 120947 0
Annabel Songco
Address 120947 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120947 0
Australia
Phone 120947 0
+61 2 9065 4616
Fax 120947 0
Email 120947 0
[email protected]
Contact person for scientific queries
Name 120948 0
Annabel Songco
Address 120948 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120948 0
Australia
Phone 120948 0
+61 2 9065 4616
Fax 120948 0
Email 120948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data for this trial will not be made publicly available due to confidentiality concerns of mental health status.


What supporting documents are/will be available?




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.