Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
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] 303938 0
None
Universal Trial Number (UTN)
Trial acronym
WMG-E
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Developmental Disorders 321520 0
Neurodevelopmental disorders 321522 0
Parental mental health 321524 0
Condition category
Condition code
Public Health 319277 319277 0 0
Health service research
Mental Health 319650 319650 0 0
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] 320241 0
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] 327155 0
Changes in developmental outcomes as determined by the LTSAE questionnaire
Timepoint [1] 327155 0
6 months post enrolment (primary end point) and 12 months post-enrolment
Primary outcome [2] 327521 0
Changes in mental health outcomes as determined by the K10 questionnaire
Timepoint [2] 327521 0
6 months post enrolment (primary end point) and 12 months post-enrolment
Primary outcome [3] 327522 0
Changes in psychosocial needs as determined by WE CARE questionnaire
Timepoint [3] 327522 0
6 months post enrolment (primary end point) and 12 months post-enrolment
Secondary outcome [1] 393988 0
Understand the experience of using WMG-E as determine by qualitative interviews.
Timepoint [1] 393988 0
6 months post-enrolment
Secondary outcome [2] 393989 0
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] 393989 0
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] 308321 0
Government body
Name [1] 308321 0
NSW Health Covid 19 Research Grants
Country [1] 308321 0
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] 309133 0
None
Name [1] 309133 0
Address [1] 309133 0
Country [1] 309133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308296 0
South Western Sydney Local Health District Research Ethics Committee
Ethics committee address [1] 308296 0
Ethics committee country [1] 308296 0
Australia
Date submitted for ethics approval [1] 308296 0
Approval date [1] 308296 0
12/02/2021
Ethics approval number [1] 308296 0
2020/PID01565

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

Contacts
Principal investigator
Name 110218 0
Prof Valsamma Eapen
Address 110218 0
Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170
Country 110218 0
Australia
Phone 110218 0
+61 0296164205
Fax 110218 0
Email 110218 0
[email protected]
Contact person for public queries
Name 110219 0
Valsamma Eapen
Address 110219 0
Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170
Country 110219 0
Australia
Phone 110219 0
+61 0296164205
Fax 110219 0
Email 110219 0
[email protected]
Contact person for scientific queries
Name 110220 0
Valsamma Eapen
Address 110220 0
Level 1, Mental Health Centre, Liverpool Hospital, 75 Elizabeth Street Liverpool, NSW, 2170
Country 110220 0
Australia
Phone 110220 0
+61 0296164205
Fax 110220 0
Email 110220 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 381790-(Uploaded-23-05-2022-10-02-10)-Basic results summary.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
Embase"Watch Me Grow- Electronic (WMG-E)" surveillance approach to identify and address child development, parental mental health, and psychosocial needs: study protocol.2021https://dx.doi.org/10.1186/s12913-021-07243-0
N.B. These documents automatically identified may not have been verified by the study sponsor.