Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001110774
Ethics application status
Approved
Date submitted
5/08/2022
Date registered
11/08/2022
Date last updated
21/04/2023
Date data sharing statement initially provided
11/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Online Mental Health Check: An Anxiety and Depression Symptom Screener for Primary-Aged Children
Scientific title
Evaluating Access to Care for Australian Children – The Online Mental Health Check: Two School Based Randomised Controlled Trials
Secondary ID [1] 307693 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 327241 0
Condition category
Condition code
Mental Health 324379 324379 0 0
Anxiety
Mental Health 324380 324380 0 0
Depression
Public Health 324427 324427 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. The responses will be automatically and immediately scored using algorithms, and the data will be transformed into a PDF report (e.g., test description, scores, elevated/not elevated). The report also includes “triage” information about services and resources that can support the child (e.g., psychoeducation, parenting resources, links to services, recommendations to see a psychologist or GP). Information contained in this report is tailored depending on the severity of the scores. Parents can email, download, or print the report.

The study design is a school-based study where we aim to conduct an individual randomized controlled trial with two intervention arms. Data will be collected during a baseline assessment and follow up assessments at 5 and 10 weeks. Parent and child report data will be collected using online questionnaires completed via a website on participants' own personal devices.

Triage vs. Standard Care. The key difference is who receives the triage information (only the triage condition will receive this information).
Participants (children and their parents) in both conditions will be asked to complete the Online Mental Health Check and outcome assessments (access to care, help seeking, stigma) at a time and place of their choosing at baseline, 5 weeks and 10 weeks. Each set of questionnaires should take approximately 20 minutes to complete. Adherence to completion of the assessments will be monitored by Qualtrics reports (parents).
Intervention code [1] 324170 0
Behaviour
Intervention code [2] 324171 0
Early detection / Screening
Comparator / control treatment
Control group:
Participants will complete the same Online Mental Health Check and outcome assessments as the intervention group, but will not receive the triage information until after the completion of the study, i.e., after their completion of the follow-up (12-week) questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 332189 0
Access to (mental health) care as measured by the Access to Evidence-Based Care Questionnaire, modified from an adapted version (Ghandi et al., 2021).
Timepoint [1] 332189 0
Baseline, 5-week follow-up, 10-week follow-up (endpoint).
Primary outcome [2] 332190 0
Help-seeking behaviour as measured by the General Help Seeking Questionnaire (Wilson et al., 2005).
Timepoint [2] 332190 0
Baseline, 5-week follow-up, 10-week follow-up (endpoint).
Primary outcome [3] 332191 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 [3] 332191 0
Baseline, 5-week follow-up, 10-week follow-up (endpoint).
Secondary outcome [1] 412500 0
Nil
Timepoint [1] 412500 0
Nil

Eligibility
Key inclusion criteria
• Children in Years 3 to 6 who are able to access a device to complete the study questions, can consent and complete questions online (with help if needed)
• Parents/carers of a child in Year K to 6 who are able to access a device to complete the study questions, can consent and complete questions online (with help if needed)
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 computer (Research Engine)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation: Minimisation created by computer software (Research Engine)
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 (mental health check, access to care, general help seeking) at each time point (baseline, 5 weeks, 10 weeks) will be presented using descriptive statistics: mean, standard deviation, and 95% confidence intervals. Interim analysis of the primary outcome data will be conducted in the event that the target sample size is not recruited. If a significant result is identified in this interim analysis, the trial will be prematurely stopped. Where futility is identified, the study will be abandoned and where the interim analysis shows an inconclusive finding, recruitment would be re-opened.
To investigate within group changes in the triage group from baseline to 5 weeks to 10 weeks, mixed-model repeated measures (MMRM) will be used for each outcome measure (mental health check, access to care, general help seeking). Time will be treated as a within-groups factor (baseline, 5 weeks, 10 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. Where necessary, data will be transformed in order to meet the normality assumptions of model residuals in order to establish the robustness of conclusions reached using raw scores. 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, 5 weeks, and 10 weeks of the intervention for each outcome measure.

To investigate between group differences in changes in clinical outcomes from baseline to 5 weeks to 10 weeks in the triage group compared to the standard care group, mixed-model repeated measures (MMRM) will then be used to evaluate differences in outcome measures across the groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
26/09/2022
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
432
Accrual to date
228
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311962 0
Charities/Societies/Foundations
Name [1] 311962 0
Johnston Foundation
Country [1] 311962 0
Australia
Funding source category [2] 313701 0
Charities/Societies/Foundations
Name [2] 313701 0
AMP Foundation Limited (as trustee for AMP Foundation Trust)
Country [2] 313701 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] 313476 0
None
Name [1] 313476 0
NA
Address [1] 313476 0
NA
Country [1] 313476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311392 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 311392 0
Ethics committee country [1] 311392 0
Australia
Date submitted for ethics approval [1] 311392 0
23/05/2022
Approval date [1] 311392 0
05/07/2022
Ethics approval number [1] 311392 0
HC220332

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

Contacts
Principal investigator
Name 120934 0
Prof Jennie Hudson
Address 120934 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120934 0
Australia
Phone 120934 0
+61 2 9065 9251
Fax 120934 0
Email 120934 0
[email protected]
Contact person for public queries
Name 120935 0
Annabel Songco
Address 120935 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120935 0
Australia
Phone 120935 0
+61 2 9065 4616
Fax 120935 0
Email 120935 0
[email protected]
Contact person for scientific queries
Name 120936 0
Annabel Songco
Address 120936 0
Black Dog Institute, Hospital Road, Randwick NSW 2031
Country 120936 0
Australia
Phone 120936 0
+61 2 9065 4616
Fax 120936 0
Email 120936 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16792Ethical approval    384469-(Uploaded-02-08-2022-12-14-49)-Study-related document.Pdf
16794Study protocol    384469-(Uploaded-20-04-2023-13-03-32)-Study-related document.docx
16795Informed consent formTrial 1: Appendix H - Parent and Child information statement and consent forms   384469-(Uploaded-20-04-2023-13-04-16)-Study-related document.docx



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.