Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000922976
Ethics application status
Approved
Date submitted
24/08/2020
Date registered
17/09/2020
Date last updated
17/09/2020
Date data sharing statement initially provided
17/09/2020
Date results information initially provided
17/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
DETECT Schools Study: Understanding the impact of COVID-19 in Western Australian Schools
Scientific title
DETECT Schools Study: Understanding the impact of COVID-19 in Western Australian Schools
Secondary ID [1] 302094 0
DoH20205875
Universal Trial Number (UTN)
Trial acronym
DETECT Schools
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 (SARS-CoV-2) infection 318709 0
Psychosocial wellbeing impact of COVID-19 318710 0
Condition category
Condition code
Public Health 316725 316725 0 0
Epidemiology
Public Health 316726 316726 0 0
Other public health
Infection 316825 316825 0 0
Other infectious diseases
Mental Health 316826 316826 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Module 1 SARS-CoV-2 asymptomatic spot testing: Randomly selected students and staff (n=150) will undergo testing for SARS-CoV-2 at a selection of 40 representative schools across the state. Duration of swab testing is 3 rounds over two school terms in 2020, and will occur monthly for three consecutive months. Total duration of observation varies with each participant due to randomised selection for swabbing. For swab collection, an oropharyngeal (throat), followed by a deep nasal swab will be taken (using the same single flocked swab). This swabbing process will cause only minimal discomfort, and is not the same as a nasopharyngeal swab (inserted further into the nasal cavity to reach the throat/pharynx).

Module 2 Enhanced COVID-19 index case response: Enhanced follow-up of any SARS-CoV-2 positive index case identified within a school during Module 1. If participants are identified as a close contact after Module 1 has completed, up until December 2020, enhanced follow-up will also be initiated. In consultation with the Public Health department, we propose further targeted testing of students and staff based on existing methodologies. Close contacts of the index case undergo two SARS-CoV-2 tests across two weeks, irrespective of symptoms, as well as keeping a daily symptom diary for 14 days. Only those who are identified as a close contact and enrolled in Module 2 will be invited to consent and participate in serology testing at days 28 – 42.

Module 3 Psychosocial Impact of COVID-19: Survey-based wellbeing assessments of student, staff and parent experiences of COVID-19 (including in response to the testing activities in Module 1). This project will conduct a quantitative quasi-experimental cross-sectional baseline and five-month follow-up survey measuring the psychosocial impacts of COVID-19 among school-aged children, their parents, and school staff in Western Australia in schools differentiated by the presence or absence of COVID-19 screening procedures. A total of 79 schools across metropolitan and regional settings have been purposely selected for invitation to participate by the WA Department of Education with 40 randomly designated by the Department as COVID-19 screening schools and 39 randomly designated as Control schools. In all 79 schools, students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12) in intervention and control schools will be invited to complete a survey. Separate surveys will be developed for students in Years 4–6 and Years 7–12 to reflect different developmental capabilities and educational settings. A 15-minute parent/caregiver survey will be administered to understand the impact of COVID-19 social interventions on their children and their families, especially interventions related to online schooling from home and social isolation on the family.
The project measures will provide an understanding of:
1. How the COVID-19 social interventions differentially impact children’s, adolescents’ and their parents’ and teachers’ physical, social, and emotional wellbeing (e.g.: sleep, anxiety, loneliness, and physical activity) across sub-populations (e.g.: age, school system) and geography.
2. How the COVID-19 social interventions are differentially impacting children/adolescents’ learning and schools’ operations across sub-populations (e.g.: year group, school system) and geography.
3. How students, school staff and parents feel about the COVID-19 testing (e.g.: acceptability, reaction).

Participation can be across all three modules, depending on whether the participant is in a control school or a testing school, and is not limited to one module only. All three modules require independent consent.
Intervention code [1] 318392 0
Diagnosis / Prognosis
Comparator / control treatment
39 representative schools across the state that will not be tested for SARS-CoV-2 but where wellbeing surveys of students and staff will be conducted.
Control group
Active

Outcomes
Primary outcome [1] 324861 0
Module 1:
The prevalence of asymptomatic SARS-CoV-2 infection among school students/staff. Confirmed detection of SARS-CoV-2 via polymerise chain reaction (PCR) testing from throat/nasal swabs.
Timepoint [1] 324861 0
Each school (inclusive of 150 randomly selected participants) will partake in spot testing approximately every month for three to six months in total. The final decision on continuation to months 4,5 and 6 will be made by the Western Australia Departments of Health and Education.
Primary outcome [2] 324862 0
Module 2:
The proportion of close contacts of an index case who test positive for SARS-COV-2 following exposure in the school setting. Confirmed detection of SARS-CoV-2 via PCR testing from throat/nasal swabs.
Timepoint [2] 324862 0
This project will align with the duration of Module 1 timelines, for a total period of three to six months. The final decision on continuation to months 4,5 and 6 will be made by the Western Australia Departments of Health and Education. Additionally, if participants are identified as a close contact after Module 1 has completed, up until December 2020, Module 2 will also be initiated.
Primary outcome [3] 324863 0
Module 3: Assessing wellbeing.
5 instruments were designed specifically for this study with the inclusion of some validated scales such as Child Health Utility 9D (CHU9D). The only validated scales included in full in instruments for this study were the CHU9D and the WHO (Five) Wellbeing Index 1995, which will be compared to benchmark data. Individual items or subsets of items from some other scales were included, but as these items were either modified or included in isolation they will not be compared to benchmark data.
Timepoint [3] 324863 0
Data will be collected in COVID-19 Screening (intervention) schools immediately following the first month of SARS-CoV-2 testing. Two months post the last SARS-CoV-2 testing month (follow-up in October 2020) for students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12). The No COVID-19 Screening (control) schools will be invited to collect data during the same window. The follow-up surveys will be administered in all study schools in October 2020.
Secondary outcome [1] 386832 0
Mental health distress - this is also a primary outcome
Assessed via CHU9D scale
Timepoint [1] 386832 0
Data will be collected in COVID-19 Screening (intervention) schools immediately following the first month of SARS-CoV-2 testing. Two months post the last SARS-CoV-2 testing month (follow-up in October 2020) for students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12). The No COVID-19 Screening (control) schools will be invited to collect data during the same window. The follow-up surveys will be administered in all study schools in October 2020.
Secondary outcome [2] 386956 0
Life satisfaction - this is also a primary outcome
Assessed via the Students' Life Satisfaction Scale
Timepoint [2] 386956 0
Data will be collected in COVID-19 Screening (intervention) schools immediately following the first month of SARS-CoV-2 testing. Two months post the last SARS-CoV-2 testing month (follow-up in October 2020) for students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12). The No COVID-19 Screening (control) schools will be invited to collect data during the same window. The follow-up surveys will be administered in all study schools in October 2020.

Eligibility
Key inclusion criteria
Module 1: For all 40 selected SARS-CoV-2 testing schools, all asymptomatic students (Years K-12) and all staff will be invited to participate in SARS-CoV-2 testing activities.
Module 2: For all 40 selected SARS-CoV-2 testing schools, students (Years K-12)/school staff who are defined as close contacts of an index positive result in that school.
Module 3: Students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12) from 79 public schools, education support services, and residential colleges identified by the Department of Education will be eligible to participate.

The inclusion criteria are specific to all student and staff participants in Module 1 and Module 2. There were no school-specific criteria. Participation in Module 3 is through passive, opt-out consent and there are no other inclusion criterion.
Minimum age
3 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Module 1:
• Recurrent nose bleeds (frequency of more than one nosebleed per week)
• Recurrent vomiting, particularly if triggered by a gag reflex
• Large/problematic tonsils awaiting a tonsillectomy (removal) procedure
• Significant anxiety about medical procedures

Module 2:
An index case with a positive SARS-CoV-2 test where no close contacts in the school could be identified.

Module 3:
• Students or parents who are not able to complete a self-report survey (e.g. speak languages other than English*, literacy or cognitive difficulties)
• Parents of students in who do not have Internet access allowing completion of the online consent and survey.

The exclusion criteria are specific to all student and staff participants in Module 1 and Module 2. There were no school-specific criteria. Participation in Module 3 is through passive, opt-out consent and there are no other exclusion criterion.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Aggregated (at the level of intervention and control) descriptive statistics (baseline frequencies and prevalence estimates, with 95% confidence intervals). Basic statistical comparisons (proportion tests, Students’ t-test, non-parametric tests – as appropriate) will be used to examine differences between intervention schools and control schools.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
29/05/2020
Date of last participant enrolment
Anticipated
Actual
30/06/2020
Date of last data collection
Anticipated
9/11/2020
Actual
Sample size
Target
30000
Accrual to date
Final
29498
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306513 0
Government body
Name [1] 306513 0
Department of Health of Western Australia
Country [1] 306513 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Telethon Kids Institute
Address
15 Hospital Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 307041 0
None
Name [1] 307041 0
Address [1] 307041 0
Country [1] 307041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306717 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 306717 0
Perth Children's Hospital
15 Hospital Avenue, Nedlands, WA 6009
Ethics committee country [1] 306717 0
Australia
Date submitted for ethics approval [1] 306717 0
Approval date [1] 306717 0
27/05/2020
Ethics approval number [1] 306717 0
Ethics committee name [2] 306724 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 306724 0
450 Beaufort Street, Highgate, WA 6003
Ethics committee country [2] 306724 0
Australia
Date submitted for ethics approval [2] 306724 0
Approval date [2] 306724 0
25/05/2020
Ethics approval number [2] 306724 0

Summary
Brief summary
The State Government is partnering with Telethon Kids Institute in a study (the DETECT School Study) to learn more about undetected SARS-CoV-2 infection among school students and staff without symptoms.It is hoped that this study will provide a greater understanding of any role that schools play in the transmission of the disease and help us to understand how students, parents and staff are coping in this challenging environment. Three study Modules will be used to address these overarching objective and the specific module aims and intended outcomes are as follows.

Module 1 - SARS-CoV-2 asymptomatic testing
Aim: Document the prevalence of SARS-CoV-2 infection in a cohort of randomly selected school students/staff for testing who are not reporting any clinical symptoms of SARS-CoV-29 (asymptomatic).

Module 2 – SARS-CoV-2 index case response
Aim: To determine the secondary attack rate of SARS-CoV-2 when detected in a school setting. Case detection includes asymptomatic cases detected in Module 1 and symptomatic cases from Module 1 schools (after presenting to a community testing facility for symptomatic testing).

Module 3 – Psychosocial impact of COVID-19
Aim: Document the psychological and social circumstances and their prevalence in a cohort of students aged 9-18 (Years 4-12), school staff and parents of children aged 3-18 (Years K-12).
Trial website
https://www.telethonkids.org.au/projects/detect-schools/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104774 0
Prof Peter Gething
Address 104774 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 104774 0
Australia
Phone 104774 0
+61 863191018
Fax 104774 0
Email 104774 0
peter.gething@telethonkids.org.au
Contact person for public queries
Name 104775 0
Ms Derry Simpson
Address 104775 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 104775 0
Australia
Phone 104775 0
+61863191065
Fax 104775 0
Email 104775 0
derry.simpson@telethonkids.org.au
Contact person for scientific queries
Name 104776 0
Prof Peter Gething
Address 104776 0
Telethon Kids Institute
15 Hospital Avenue, Nedlands, WA 6009
Country 104776 0
Australia
Phone 104776 0
+61 863191018
Fax 104776 0
Email 104776 0
peter.gething@telethonkids.org.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?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcceptability of OP/Na swabbing for SARS-CoV-2: a prospective observational cohort surveillance study in Western Australian schools.2022https://dx.doi.org/10.1136/bmjopen-2021-055217
N.B. These documents automatically identified may not have been verified by the study sponsor.