ANZCTR - Registration

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

ACTRN12625000363482p

Ethics application status

Submitted, not yet approved

Date submitted

3/04/2025

Date registered

24/04/2025

Date last updated

24/04/2025

Date data sharing statement initially provided

24/04/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Kids Connect Integrated Hybrid program: a tiered care approach to optimise access to screening and support for child’s developmental, parental mental health, and family psychosocial needs for ALL families (including priority populations).

Scientific title

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Child developmental delays

Uptake and utilisation of health services for families

Anxiety

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Kids Connect hybrid program will be used as a universal digital screening and ongoing monitoring tool with pathways to universal and targeted tiered care services. The Watch Me Grow-Electronic (WMG-E) platform will provide a digital front door to systematically identify the child’s developmental, parental mental health, and family social care needs through relevant measures on REDCap.

Families will be recruited at the postnatal checks through child and family health clinics, GP practices or community groups, when a child is 0-10 weeks (BASELINE). After completing the baseline WMG-E survey, participants will be randomised into intervention and control groups. Both groups will be followed up every 6 months post randomisation up till 24 months, with the link being sent via email or SMS automatically through REDCap. The survey takes 20-30 mins to complete.

The Kids Connect Tiered service approach:
-Universal services (Tier 1): both intervention and control groups will get enhanced usual care including anticipatory guidance on general health and developmental literacy resources and tips.

Intervention group will further receive:
- Additional resources (Tier 2): Parents/carers with mild concerns will be provided with guidance on locally accessible services for child development and parental mental health. These will be sent via automated REDCap email when families have certain scores on relevant measures. Uptake and adherence will be assessed through survey-specific measure at following time-points.

- Targeted services (Tier 3): Parents/carers with moderate child developmental concerns, or mental health issues will be connected via digital navigation to online/in-person services (e.g., Parent groups, Karitane, Tresillian, etc). Digital navigation means that a service navigator will contact the family through email/SMS to provide customised resources/links for family to access based on their scores on the WMG-E. Uptake and adherence will be assessed via a follow-up email/SMS 1-2 weeks after initial contact as well as through survey-specific measures at the next timepoint.

- Service Navigation (Tier 4): Parents/carers with complex health and family psychosocial needs will be linked with a Service Navigator through a 15-30 minutes check-in call, Based on survey responses and initial call, service navigator will connect them with relevant and appropriate health (developmental assessments and interventions); and social care providers (e.g., place-based hubs, intensive parenting interventions, programs to improve family and community connectedness) so that the families receive wraparound care with ‘warm handover’ to referred services and ‘continuity of care’ to ensure the referral needs are met. Uptake and adherence will be assessed via a follow-up calls once a month for 3 months after initial contact as well as through survey-specific measures at the next timepoint.

Controls: Participants in the control group will complete the baseline measure and receive enhanced care (Tier 1), and will then be followed up every 6 months till 24 months through a study specific survey assessing the completion of child developmental checks, parental mental health and family psychosocial needs without the provision of further support (tiers 2,3 and 4). The baseline and endpoint survey for intervention group and control group will be the same, but the control group will only be monitored (through study-specific survey) for issues in the domains of child development, parental mental health and family psychosocial needs in the follow-up time points post randomisation.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

Comparator / control treatment

Parents/carers and children in the control group will receive enhanced usual care via WMG-E universal screening (Tier 1)

Control group

Active

Outcomes

Primary outcome [1]

Breastfeeding practice and support needs

Timepoint [1]

Baseline, 6, 12 (primary timepoint), 18, and 24 months post randomisation

Primary outcome [2]

Parental mental health

Timepoint [2]

Baseline, 6, 12 18, and 24 months (primary endpoint) post randomisation

Primary outcome [3]

Completion of child developmental checks

Timepoint [3]

Baseline, 6 months, 12 months, 18 months and 24 months (primary endpoint) post-randomisation

Secondary outcome [1]

Monitoring of child development, parental mental health and family psychosocial needs for control group

Timepoint [1]

At 6, 12 and 18 months post randomisation

Secondary outcome [2]

Health service satisfaction

Timepoint [2]

Baseline, 6, 12, 18 and 24 months post-randomisation

Secondary outcome [3]

Maternal depression

Timepoint [3]

Baseline, 6 and 12 months post-randomisation

Secondary outcome [4]

Child developmental delays

Timepoint [4]

Baseline, 6, 12, 18 and 24 months post-randomisation

Secondary outcome [5]

Healthcare service utilisation

Timepoint [5]

Baseline, 6,12,18, and 24 months post randomisation

Secondary outcome [6]

Unmet family psychosocial needs

Timepoint [6]

Baseline, 6, 12,18, and 24 months post-randomisation

Secondary outcome [7]

Family support needs

Timepoint [7]

Baseline, 6, 12,18, and 24 months post-randomisation

Secondary outcome [8]

Efficacy of Kids Connect tiered support

Timepoint [8]

6,12,18 and 24 months post-randomisation

Secondary outcome [9]

Economic evaluation

Timepoint [9]

Baseline, 6, 12 18 and 24 months post-randomisation

Eligibility

Key inclusion criteria

Participants will include parents/carers of babies recruited post birth (0-10 weeks) with follow-up to 24 months of age attending birthing wards, postnatal wards and/or CFHN clinics across SWSLHD, MLHD and SLHD
- All participants will possess the ability to provide informed consent

Minimum age

0 Weeks

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
- Do not reside in geographical area of study.

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)

Computerised randomisation using the Watch Me Grow weblink

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computerised randomisation

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2025

Actual

Date of last participant enrolment

Anticipated

15/12/2025

Actual

Date of last data collection

Anticipated

20/12/2027

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Ministry of Health Translational Research Grants Scheme

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council Grant

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

SouthWest Sydney Local Health District

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.swslhd.health.nsw.gov.au/ethics/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/09/2024

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The Kids Connect Integrated Program aims to increase the engagement of parents and families with the health services by optimising the uptake of child developmental checks through the WMG-E platform. Secondly, this program will include screeners for parental mental health and unmet family psychosocial needs. 
Intervention in this study is tiered care and support provided to families based on the survey responses. While both both groups receive universal resources (Tier 1), intervention group will receive targeted support for tiers 2, 3 and 4. Tier 2 will include general information of local support services via automated REDCap email. Tier 3 will include digital contact with Service navigator and recommendations of targeted support services, follow-up with email/SMS check-in in the next month. Tier 4 will include direct contact with service navigator over phone, with assistance to access services (warm hand-over), with regular follow-up calls over the next few months, as appropriate. 
Outcomes include the uptake of child developmental checks, utilisation of resources and services for child development, parental mental health, breastfeeding practices, and family psychosocial needs. 
We hypothesise that the provision of extra resources and service navigator support will increase the uptake of developmental checks and mental health screeners, will increase the utilisation of health services and improve outcomes of parental mental health, breastfeeding practices and family psychosocial needs.

Trial website

Trial related presentations / publications

Public notes

Every nine minutes in Australia a child is born who is at risk of developmental vulnerability. Every year, about 63,448 Australian children are starting school not ready to learn and thrive, with consequent lifelong morbidities, reduced economic opportunity, and intergenerational adversity. These rates are doubled in children from priority populations (e.g., Aboriginal, CALD/multicultural, regional/remote backgrounds). The 2020 Productivity Commission Report called for regular developmental checks in early childhood, and the recent National Children’s Mental Health and Wellbeing Strategy highlighted the need for service integration for optimal start to life. The National Action Plan for the Health of Children and Young People: 2020-2030; and the NSW First 2000 Days policy have called for better engagement with child developmental checks and support for priority populations. While the government policies and strategies have highlighted the need for improving access/engagement with CFH services, our research with priority populations has identified an ‘inverse care law’ with those from the most disadvantaged backgrounds with the highest developmental risk to be least likely to access health services early. They often present after the disorders have set in, but late intervention is estimated to cost $15.2 billion/year in education, health, and welfare costs. Research has shown early identification and intervention to reduce the rate of later diagnosis of autism by a third, with an estimated mean differential cost of $5131 per child. Thus, while the benefits are clear, currently, there is an evidence gap with no systematic mechanism to engage all children including “hard-to-reach” families. Further, our work with consumers have identified service fragmentation and the emphasis on risk rather than strengths as a barrier. Hence, a systems refresh is urgently needed for equitable service access, and effective integration of health with wrap around social care.

Contacts

Principal investigator

Name

Prof Valsamma Eapen

Address

Infant, Child, and Adolescent Mental Health Services (ICAMHS), L1 MHC, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170

Country

Australia

Phone

+61296164205

Fax

[email protected]

Contact person for public queries

Name

Valsamma Eapen

Address

ICAMHS, L1 MHC, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170

Country

Australia

Phone

+61296164205

Fax

[email protected]

Contact person for scientific queries

Name

Valsamma Eapen

Address

ICAMHS, L1 MHC, Liverpool Hospital, Elizabeth Street, Liverpool, NSW 2170

Country

Australia

Phone

+61296164205

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically