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Addressing health equity by screening for neurodevelopmental concerns in primary healthcare

Evaluating the effect of the Tracking Cube on identification of neurodevelopmental concerns in primary healthcare

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001116516
Acronym
Nil
Enrollment
48
Registered
2024-09-17
Start date
2025-05-09
Completion date
2028-02-29
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Screening children and adolescents at-risk of neurodevelopmental concerns in primary healthcare starts them on early pathways of support and catches those who might otherwise fall through service gaps. To assist health care decisions and help plan treatment pathways, we spent 5 years co-designing the Tracking Cube: a culturally responsive, tiered neurodevelopmental screening approach integrated with child well-health checks. After pilot implementation at an Indigenous remote primary health service, neurodevelopmental concerns were 4 times more likely to be identified using the Tracking Cube compared to usual care. Promisingly, specialist referral numbers did not significantly increase, and specialists reported receiving more appropriate referrals. This project will use a stepped wedge cluster randomised trial to measure the effectiveness of the Tracking Cube at diverse primary healthcare partner sites. The primary hypothesis is that use of the Tracking Cube will increase the identification of neurodevelopmental concerns. Secondary hypotheses are that the Tracking Cube will increase identification of children at-risk of neurodevelopmental disorders, increase follow-up of these chidren in primary care, and increase the appropriateness of referrals to specialists. Outcomes from this project will inform best practice around child and adolescent screening and also drive the Indigenous health equity agenda nationwide.

Interventions

The Tracking Cube is a 6 tiered process. It is considered to be the intervention for this project. The six tiers are: Informed consent (Tier 1), history (Tier 2), the Rapid Neurodevelopmental Assessment (RNDA; Tier 3); collaborative information from carers and teachers (Tier 4); feedback and support (Tier 5), and comprehensive assessment (Tier 6). Tiers are woven into usual care medical components. This project evaluates the implementation of the first 4 tiers. Tiers 5 and 6 are completed at the

The Tracking Cube is a 6 tiered process. It is considered to be the intervention for this project. The six tiers are: Informed consent (Tier 1), history (Tier 2), the Rapid Neurodevelopmental Assessment (RNDA; Tier 3); collaborative information from carers and teachers (Tier 4); feedback and support (Tier 5), and comprehensive assessment (Tier 6). Tiers are woven into usual care medical components. This project evaluates the implementation of the first 4 tiers. Tiers 5 and 6 are completed at the discretion of the health service. The occasions of service for Tiers 5 and 6 will be documented as ‘follow-up’, but outcomes from these occasions of service will not be evaluated, as this is not the research question. Tier 1 takes around 10 minutes. Tier 2 takes around 30 minutes. Tier 3 takes around 30 minutes. Tier 4 takes around 30 minutes. However, the Health Care Providers (HCP), carer and child work together through each Tier of the Tracking Cube - there is no time limit. Children and carers can take breaks as needed. Therefore, eligible participants will progress with the Tracking Cube at their own pace. For example, in Tier 1 the HCP discusses participation with carers and patients. Participation can be discussed over multiple appointments as needed. The health service determines the most appropriate time to start the Tracking Cube. For example, at child well-health checks or at any appointment with the HCP. HCPs enter information into a digital platform, allowing site-based data control. Each primary healthcare site has a license to use this platform. This previously developed digital infrastructure was co-designed for research purposes. Examples of factors/data that will be entered into the digital platform are: historical factors (e.g. family history, maternal birth complications if known, developmental milestones); neurodevelopmental assessment results (e.g., cognitive, speech, attention, vision and hearing) and caregiver concerns about the child (e.g. behavioural and sleep patterns). The digital platform is hosted securely and meets all national compliance and security standards. Providing an intuitive user experience, aggregated data is presented in dashboards, which summarise risk and protective factors, screening results and carer concerns for HCPs to view at a glance. This helps practitioners augment real-time clinical decisions. This is a point of difference with usual care. Built-in e-consent has the potential for data exchange with other organisations involved in the child's care. An editable summary, recommendations and referral can be generated as needed for HCP review. Using a stepped-wedge randomised design, each site will commence 3 months after each other. Each site will progress through 4 phases: exploration (3 months), preparation (3 months), intervention (2 years), and sustainability (6 months). Exploration is about understanding the workflow at each site to ensure the Tracking Cube can fit into existing workflows, and co-designing the localisation of the Tracking Cube where needed. Each HCP is trained to a standard during the preparation phase. The training protocol involves online modules (6 hours) that include video examples, follow-up tele-mentoring (Microsoft Teams) by the research team, and an online competency assessment at the end of training. During this time, the research team also works with the health service to integrate the Tracking Cube into usual care workflows. Weekly online tele-mentoring occurs to adjust organisational flow, and address barriers to incorporating the Tracking Cube. The intervention phase continues tele-mentoring from project staff with allied health backgrounds as needed to ensure fidelity with the protocol. Monthly audits of the digital platform will highlight drift from protocol and feedback will be provided to HCPs. Fidelity checklists will be collected every 6 months to support HCPs in identifying where they may have drifted from protocol. This will provide insights about adherence to the Tiers. In the sustainability phase, clinicians will continue to use the Tracking Cube, but without support from the research team.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for primary healthcare sites: (1) provide accredited primary healthcare service; (2) a consenting HCP providing <18-year-old health checks; (3) no systematic neurodevelopmental screening for <18-year-olds; (4) no standardised triage to specialists for <18-year-olds at-risk of neurodevelopmental concerns; (5) consent of health service management to participate. Inclusion criteria for families: All consenting families receiving a health check at an eligible site will be included; no exclusion criteria.

Exclusion criteria

No specific additional exclusion criteria, must meet inclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026