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Trial registered on ANZCTR


Registration number
ACTRN12624000806561p
Ethics application status
Submitted, not yet approved
Date submitted
18/06/2024
Date registered
29/06/2024
Date last updated
29/06/2024
Date data sharing statement initially provided
29/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Strengths-based, tiered, accessible, resources and supports (STARS for Kids) program
Scientific title
Strengths-based, tiered, accessible, resources and supports (STARS for Kids): Effect of a co-designed blended service delivery framework to identify and support child development, parental mental health, and psychosocial needs among parents/carers of children aged 6 months to 3 years
Secondary ID [1] 312356 0
None
Universal Trial Number (UTN)
Trial acronym
STARS for Kids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child Developmental delay 334135 0
Parental mental illness 334201 0
Condition category
Condition code
Public Health 330808 330808 0 0
Health service research
Mental Health 330809 330809 0 0
Other mental health disorders
Public Health 330810 330810 0 0
Health promotion/education
Mental Health 330865 330865 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the co-designed STARS for Kids tiered care model. This model was co-designed with parents/carers as well as service providers in all three sites (South Western Sydney, Taree, and Wannerroo). Participants were presented with example case scenarios about tier models and invited to provide feedback using interviews (30-40 minutes), workshops, and focus groups up to 3 hours. Additionally, other elements such as the barriers to access (digital literacy level, role of service navigators, etc) were also considered in the co-design activities. The co-design process will be ongoing to ensure that the research considers the specific needs of each population throughout the phase of the project.

This comprises universal and tiered care services as detailed below.

Universal service: The universal service comprises the Watch Me Grow – Electronic (WMG-E) as a universal digital screening tool that has been found to be effective and acceptable to families (including translations and supported by multicultural, out-of-home care, refugee, or other support workers, as needed) for the early identification of child developmental, parental mental health, and family psychosocial needs (Findings from clinical trial - ACTRN12621000766819). The innovative web-based screening and monitoring program provides unique opportunities to reach vulnerable families at their homes and communities. WMG-E uses opportunistic contacts that the family has with trusted service providers, such as immunisation visits or routine service contact with General Practitioners (GPs), playgroups, social care agencies, government, and non-governmental organizations (NGOs) in order to empower parents to engage with child developmental checks. The program aims to identify child development needs while also ascertaining and de-stigmatising mental health and psychosocial screening, and provide urgent targeted interventions, particularly using digital technology.

WMG-E contains in-built logic to identify children at developmental risk at the point of care to aid shared decision-making using several primary and secondary assessments (see primary and secondary outcomes). This can be accessed via QR code via poster/flyers or weblink via email. It will take approximately 30-40 minutes for parents/carers to self-complete the assessments. Based on the WMG-E screening results, resources and supports are provided as per the level of risk. Further, the results are automatically transmitted to parent/carer and the service provider who will conduct further clinical review as needed. Once engaged, the platform issues automated reminders to the family, prompting them to take the developmental checks again at the next recommended ages and stages (e.g., 6, 12, 18, 24, 36, 48, and 60 months of age) derived from guidelines as per Personal Health Record Blue Book program in NSW or Purple Book in WA.

Tiered service approach: Based on complexity and needs.

Additional resources (Tier 1): Parent/carers with mild concerns will be provided with anticipatory guidance, such as mental health literacy, sign posting for resources, awareness, etc will be administered via email and text messages to parents/carers by the digital navigator. Given the nature of risk in Tier 1, no further consultations will be provided in this tier. However, the digital service navigator and the research team will follow up parents/carers at 6-monthly timeperiod to reassess based on their next 6-monthly completion of assessments.

Targeted services (Tier 2): Parent/carers with child developmental concerns or a mild to moderate mental health issue will be connected via digital navigation with online/in-person services (e.g., Triple P online, STEPs program, etc). The digital navigator will either contact the parents/carers via text, email or telephone to connect them to appropriate services. The number of sessions in the in-person/online services and any further review will depend on the specific needs of the family. For example, this tier will include, but not limited, to group based parenting supports of up to 2 hours, free triple P resources, etc. Similar to tier 1, the digital service navigator and the research team will follow up parents/carers in this tier 2 at 6-monthly time period to reassess based on their next 6-monthly completion of assessments.

Service Navigation (Tier 3): Parents/carers with complex health and family psychosocial needs will be linked with an In-person Service Navigator who will connect them with relevant health (e.g. developmental assessments and intervention) and social care providers (e.g., place-based hubs, intensive parenting interventions, strengths-based approaches to increase family and community connectedness etc.) so that the families receive wraparound care with ‘warm handover’ to referred services and ‘continuity of care’ to ensure the referral needs are met. The number of sessions in the tier 3 services and any further review will depend on the specific needs of the family.

Data collection will be monitored via REDCap, a secure web application for building and managing online surveys and databases. Where needed, a research staff will send reminders to those participants who have not completed all the baseline assessments and may help those with issues of digital literacy to guide them through completion.
Intervention code [1] 328851 0
Early detection / Screening
Intervention code [2] 328852 0
Treatment: Other
Comparator / control treatment
Parents/carers in the control group will receive enhanced usual care via WMG-E universal screening as well as additional resources (Tier 1).
Control group
Active

Outcomes
Primary outcome [1] 338570 0
Parent/carer-reported completion of child developmental checks (as outlined in the Personal Health Record Blue Book in NSW and Purple Book in Western Australia) between the intervention and control group.
Timepoint [1] 338570 0
Baseline, 6-, 12-(primary endpoint), 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [1] 436482 0
Changes in the proportion of children identified as at developmental risk via Learn the Signs Act Early (LTSAE) between the intervention and control group.
Timepoint [1] 436482 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [2] 436484 0
Changes in the proportion of children with concerns for autism via the Quantitative Checklist for Autism in Toddlers (Q-CHAT-10) between the intervention and control group.
Timepoint [2] 436484 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [3] 436485 0
Changes in the child's behaviour via the Survey of Well-being of Young Children (SWYC) Paediatric Symptoms Checklist between the intervention and control group.
Timepoint [3] 436485 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [4] 436486 0
Changes in the proportion of parents/carers identified as experiencing psychological distress and at risk of depression and anxiety symptoms, measured using the Kessler Psychological Distress Scale (K10) questionnaire between the intervention and control group.
Timepoint [4] 436486 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups.
Secondary outcome [5] 436487 0
Changes in the proportion of parents/carers identified as having more than one unmet social need via the Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education (WE CARE) questionnaire between the intervention and control group.
Timepoint [5] 436487 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [6] 436696 0
Health service use by the families (self-reported and by service providers)
Timepoint [6] 436696 0
Baseline, 6-, 12-, 18-, and 24-months follow-up timepoints in both groups
Secondary outcome [7] 436697 0
Satisfaction with the service
Timepoint [7] 436697 0
6-, 12-, 18-, and 24-months follow-up timepoints in the intervention group only.
Secondary outcome [8] 436714 0
Understand parents/carers’ experiences of accessing the STARS for Kids program
Timepoint [8] 436714 0
Data will be collected at 12 and 24 months post-baseline in both groups.
Secondary outcome [9] 436715 0
Understand service providers’ experiences of accessing the STARS for Kids program
Timepoint [9] 436715 0
Data will be collected at 12 and 24 months post-baseline in both groups.
Secondary outcome [10] 436717 0
Economic analysis and dynamic simulation modelling
Timepoint [10] 436717 0
Economic analysis will consider data from primary and above listed secondary outcomes at baseline, 6-, 12-, 18-, and 24-months follow-up timepoints.

Eligibility
Key inclusion criteria
Parents/Carers
- Participants will include parents/carers of children aged 6 months to 3 years at the three sites (South Western Sydney and Taree in NSW, Wannerro in WA) attending GP, child and family or other health services, supported playgroups, and other social care groups, etc.
- Ability to provide informed consent.

Service Providers (For the implementation evaluation phase only)
- Service providers aged over 18 years providing care at relevant sites
- Ability to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Parents/carers who do not have a child within the age range in the inclusion criteria
- Cannot be contacted via telephone or email
- Does not reside in geographical area of study.
- Less than 18 years of age at enrolment

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)
Upon completion of the consent forms, participants will be randomised to either the intervention or enhanced care group via the WMG-E platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized randomisation software will be used to create a randomisation table via REDCap (a secure web application for building and managing online surveys and databases). Participants will be assigned randomly to each arm ensuring a 50:50 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Impact evaluation: To compare outcomes between the intervention and control group, we will use an intention to treat analysis: the Fisher’s test for binary outcomes; Chi-square method for categorical outcomes; non-parametric method (e.g., Wilcoxon rank-sum test); and parametric methods (e.g., t-test) for continuous variables and ordinal variables. As the outcomes will be measured repeatedly, multilevel regression analysis will be undertaken to examine impact of the tiered care model on outcomes over time, controlling for the plausible confounders (e.g., sociodemographic characteristics). The generalised estimating equations method will be used in the regression analysis considering potential clustering effect by site. Additionally, descriptive analysis will be undertaken with frequencies and proportions, by the research team using R software.

Implementation evaluation: Interviews will be recorded digitally and following transcription will be analysed via an iterative thematic analysis framework using NVivo Pro 12 software.

Economic analysis and dynamic simulation modelling phase: The economic analysis will be conducted in three stages. First, to assess the cost of implementing the STARS model to accurately identify and address needs, and the expected increase in parental engagement/uptake of services. Second, the assessment of economic value will be undertaken from both: (i) a health sector perspective and include child developmental outcomes, service costs, health utilities (using the K10) and changes in acute service use (e.g. ED presentations), (ii) a societal perspective will then widen the potential benefits to include, for example, productivity changes and avoidance of other acute services (e.g. homelessness) over time. This will rely on secondary literature regarding known relationships between study outcomes e.g. between K10 categories and economic participation. A return-on-investment analysis will evaluate the overall net benefit (inclusive of savings). Third, longer term costs and benefits will be modelled using a system dynamics model. This will create a digital representation of STARS, the wider service system and outcomes of interest to project life course impacts. To inform model parameters (trajectories, outcomes, and costs) evidence will be synthesised from several sources, including the trial results, other longitudinal datasets relating to the life-course and estimates from the literature. The model will enable ‘what-if’ policy analyses to identify opportunities to further improve outcomes by, for example, investing in scaling-up STARS, synergistic interventions (e.g. greater availability of referral services) and wider structural drivers of needs (e.g. opportunities for employment) to ensure the needs of children and guardian needs are more fully met.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA

Funding & Sponsors
Funding source category [1] 316751 0
Government body
Name [1] 316751 0
National Health and Medical Research Council - Medical Research Future Fund
Country [1] 316751 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney (UNSW)
Address
Country
Australia
Secondary sponsor category [1] 318977 0
None
Name [1] 318977 0
Address [1] 318977 0
Country [1] 318977 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315523 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315523 0
Ethics committee country [1] 315523 0
Australia
Date submitted for ethics approval [1] 315523 0
28/06/2024
Approval date [1] 315523 0
Ethics approval number [1] 315523 0

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

Contacts
Principal investigator
Name 134962 0
Prof Valsamma Eapen
Address 134962 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170
Country 134962 0
Australia
Phone 134962 0
+61 0296164205
Fax 134962 0
Email 134962 0
[email protected]
Contact person for public queries
Name 134963 0
Valsamma Eapen
Address 134963 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170
Country 134963 0
Australia
Phone 134963 0
+61 0296164205
Fax 134963 0
Email 134963 0
[email protected]
Contact person for scientific queries
Name 134964 0
Valsamma Eapen
Address 134964 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170
Country 134964 0
Australia
Phone 134964 0
+61 0296164205
Fax 134964 0
Email 134964 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.