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Trial registered on ANZCTR

Registration number

ACTRN12621000766819

Ethics application status

Approved

Date submitted

12/04/2021

Date registered

21/06/2021

Date last updated

21/06/2021

Date data sharing statement initially provided

21/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

A digital solution to address the mental health and psychosocial impacts of the pandemic for children and their parents in the first 2000 days

Scientific title

“Watch Me Grow- Electronic (WMG-E)” surveillance approach to identify and address child development, parental mental health, and psychosocial needs.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

WMG-E

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Child Developmental Disorders

Neurodevelopmental disorders

Parental mental health

Condition category

Condition code

Public Health

Health service research

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The service navigator will first triage families based on their level of risk (as indicated by the WMG-E platform which screens for developmental, psychological, and psychosocial risk. These screeners will take between 10-15 minutes to complete). Low risk families will be linked with local services and may also be provided with information on online resources (e.g. free to access online parenting programs such as ParentWorks or Family Man) or therapist assisted interventions (e.g., online or in-person Parent-Child Interaction Therapy via Karitane, a large NSW parenting services provider). For families who are highly vulnerable, in addition to receiving resources and linkages to services as mentioned above, they will receive in-person assessments (through a KIDS-Connect hub with capacity to reach families at homes or other community facilities) to determine the complexity of health needs followed by appropriate referrals and ‘warm hand over’ to recommended services. The duration of in-person assessments will depend on the needs identified by the WMG-E, however, these assessments generally range from 30 to 60 minutes. Once the in-person assessment is completed and families are linked with recommended services, the type and duration of services they receive will depend on their needs. For example, families with psychological needs may receive 10, 60-minute sessions with a psychologist while families with unmet psychosocial needs who access services such as Uniting may receive 2-3 sessions targeted at addressing psychosocial needs. Furthermore, these families will receive follow-up by a research officer to ensure engagement with recommended services and continuity of care. Follow-ups will occur fortnightly via telephone for a duration of 10 to 20 minutes.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

Participants allocated to the control group will complete Time 1 screeners using the WMG-E platform and, if indicated, will also receive a message that their responses to the questionnaires suggest developmental, psychological, and/or psychosocial risk and to seek assistance from local organisations. They will then be invited via email to complete Time 2 and Time 3 questionnaires. Participants in the control group will not receive access to a service navigator.

Control group

Active

Outcomes

Primary outcome [1]

Changes in developmental outcomes as determined by the LTSAE questionnaire

Timepoint [1]

6 months post enrolment (primary end point) and 12 months post-enrolment

Primary outcome [2]

Changes in mental health outcomes as determined by the K10 questionnaire

Timepoint [2]

6 months post enrolment (primary end point) and 12 months post-enrolment

Primary outcome [3]

Changes in psychosocial needs as determined by WE CARE questionnaire

Timepoint [3]

6 months post enrolment (primary end point) and 12 months post-enrolment

Secondary outcome [1]

Understand the experience of using WMG-E as determine by qualitative interviews.

Timepoint [1]

6 months post-enrolment

Secondary outcome [2]

The cost-effectiveness of WMG-E as determined by an economic evaluation, which will use generalized estimating equations (GEE) and ‘within-trial’ analyses to capture cost-effectiveness by converting K-10 scores to health utilities using a mapping algorithm; and estimating affordability if the intervention is implemented routinely.

Timepoint [2]

Post-data collection (12 months post enrolment)

Eligibility

Key inclusion criteria

Children aged 6 months to 3 years in either the Murrumbidgee LHD or Fairfield LGA attending CFHS, refugee health services, supported playgroups, parenting groups, Karitane services, GP practices, special paediatric clinics, or Sustaining NSW families programs.

Minimum age

6 Months

Maximum age

3 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

None

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Individual-level randomization. When services choose to participate they are asked to contact all parents enrolled to attend their service and email them a link to the WMG-E web tool. The email contains the study teams contact details which families can use to contact the study team if they require more information. Parents/caregivers of children will complete the consent form and baseline questionnaires online. They will then be randomly allocated to intervention or control condition by the weblink (REDCap).

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) via REDcap will be employed to randomize participants, assigning 50% of participants to each condition.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Assuming power=80%, alpha=0.05, and a medium effect size (d = 0.2) for within-between interactions in a repeated measures MANOVA with 2 groups and 3 measures the sample size should be 244. Taking non- and partial-adherence and dropout into account the require sample size was revised to 300 (150 per group).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2021

Actual

Date of last participant enrolment

Anticipated

3/01/2022

Actual

Date of last data collection

Anticipated

3/01/2023

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Health Covid 19 Research Grants

Address [1]

Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170

Country [1]

Australia

Primary sponsor type

Hospital

Name

South Western Sydney Local Health District

Address

75 Elizabeth Street Liverpool, NSW, 2170

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Research Ethics Committee

Ethics committee address [1]

Level 2, UNSW Clinical School
Liverpool Hospital, 75 Elizabeth Drive, Liverpool,
NSW 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/02/2021

Ethics approval number [1]

2020/PID01565

Summary

Brief summary

Australian families with preschool/school children have been experiencing significant distress during the COVID-19 pandemic and it is estimated that 1,600,000 Australian families will experience financial hardship during the pandemic. The associated economic recession is resulting in widespread job losses and financial stress, adding further distress. An extra three quarters of a million children are now living in families experiencing employment stress with three suburbs from South West Sydney (SWS) in the top 10 communities impacted3 and marginalised families in rural communities have been further isolated as well. Parental mental health difficulties consequent to the pandemic will adversely impact children’s development and well-being. Specifically, families from priority populations such as from culturally and linguistically diverse (CALD) and rural/regional backgrounds are particularly at risk of poor health outcomes. This has been compounded by the closure of Child and Family Health Nurse (CFHN) services for in-person consultation which has substantially reduced access to resources for vulnerable families during the pandemic. 
The Watch Me Grow – Electronic (WMG-E) Platform is an innovative technology that will provide a unique opportunity to reach vulnerable families at their homes, critical during the current pandemic. WMG-E has been evaluated for child developmental monitoring and we now propose to expand this to screening and addressing parents’ mental health and unmet psychosocial needs (e.g. financial support, housing) - optimising the family’s wellbeing. We will use this "virtual care approach" to focus on a predominantly CALD community (Fairfield in SWSLHD) and a regional/rural area (Murrumbidgee LHD). We will utilise the opportunistic contact for routine CFHN checks to engage and empower parents (including those who would otherwise not engage with health services), normalise and de-stigmatise mental health and psychosocial screening, and provide urgent targeted interventions.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Valsamma Eapen

Address

Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170

Country

Australia

Phone

+61 0296164205

Fax

[email protected]

Contact person for public queries

Name

Valsamma Eapen

Address

Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170

Country

Australia

Phone

+61 0296164205

Fax

[email protected]

Contact person for scientific queries

Name

Valsamma Eapen

Address

Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170

Country

Australia

Phone

+61 0296164205

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			381790-(Uploaded-23-05-2022-10-02-10)-Basic results summary.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	"Watch Me Grow- Electronic (WMG-E)" surveillance approach to identify and address child development, parental mental health, and psychosocial needs: study protocol.	2021	https://dx.doi.org/10.1186/s12913-021-07243-0

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically