RecruitingACTRN12621000680864

"Watch Me Grow Integrated approach - WMG- I”: A web-based developmental surveillance approach for uptake of childhood screening and intervention

“Watch Me Grow Integrated approach - WMG- I”: The effect of a web-based developmental surveillance approach on uptake of childhood screening and intervention in a primary care setting


Sponsor

University of New South Wales, Sydney (UNSW)

Enrollment

2,000 participants

Start Date

Apr 26, 2022

Study Type

Interventional

Conditions

Summary

Delayed identification of childhood developmental and behavioural problems and its impact on school readiness have been consistently reported. Whilst Australia has an excellent State-based Child Health and Developmental Screening and Surveillance program its utilisation in children under 5-years is < 20%. Poor uptake is due, in part, to parental access issues, perceived usefulness and the clinical complexities of referrals and managements. At present there is no proven system to improve surveillance attendance and its impact on costs and school readiness. In this study we hope to test the efficacy of integrating a web-based comprehensive developmental surveillance and child health nurse triage supported system in primary care to determine if it effectively engages parents improving long-term attendance, early intervention and school readiness.


Eligibility

Sex: Both males and femalesMin Age: 16 MonthssMax Age: 5 Yearss

Plain Language Summary

Simplified for easier understanding

Regular developmental check-ups in early childhood are one of the most effective ways to catch developmental or behavioural concerns before they affect a child's school readiness and long-term wellbeing. Yet in Australia, fewer than 1 in 5 children under 5 complete the recommended surveillance visits. This study tests whether a web-based system — where parents complete developmental screening online before their visit, supported by a child health nurse — can improve attendance, early identification of problems, and timely referrals to support services. The study is run through general practices in trial sites, targeting families who bring their toddlers in for the 18-month immunisation visit. The hope is that by making the process more convenient, engaging, and accessible for parents, more children will get the developmental support they need earlier. The study is open to children aged 16 to 35 months whose families attend a participating GP practice for immunisation or other health needs. There are no exclusion criteria — all families presenting during the study period are eligible to participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This study aims to assess the effectiveness of integrating a web-based developmental surveillance (screening, referral and follow-up) approach in primary health care settings to improve uptake of chil

This study aims to assess the effectiveness of integrating a web-based developmental surveillance (screening, referral and follow-up) approach in primary health care settings to improve uptake of childhood screening and intervention, parental education, school readiness, child behaviour and resource costs when children attend General Practice visits. This is a cluster randomised controlled trial. Forty General Practices (GPs) (20 each in Brisbane, Queensland and Sydney, New South Wales) who routinely see children for immunisation or other health concerns will be randomised to use the web based surveillance tool "Watch Me Grow-Integrated" (WMG-I) or receive Surveillance as Usual (SaU) in their practice. The study will recruit 2000 children (1000 WMG-I and 1000 SaU) across practices. Intervention: WMG-I Group, a web-based integrated-service approach to child developmental screening and surveillance will be provided when children (aged 18-months of age; age range 16 to 35-months) attend a GP appointment. Parents/caregivers of children will: (1a) complete; consent, trial entry questions (socio-demographics, birth/health information) and standardised developmental screens using the WMG-I weblink on a device of their choice (mobile phone/tablet) whilst in the GP waiting room at Time 1. The developmental screens include: Parent Evaluation of Developmental Status (PEDS), Quantitative Checklist for Autism in Toddlers – 10-item (Q-CHAT-10), Learn the Signs Act Early (LTSAE), and for those children with failed primary screens, parents will complete the Ages and Stages Questionnaire-Third Edition (ASQ-3) online. Parents will also complete the Kessler Psychological Distress Scale – 6 (K6). These questionnaires will take approximately 15 minutes to complete. Automated scoring according to screening manuals will be emailed to the parent and sent via secure message to the GP prior to consultation to facilitate point-of-care consultation. (1b) Time 1 surveys are reviewed by a Child and Family Health Nurse (CFHN) and/or ‘Triage and Review Team’. Those who are identified to be at risk of developmental concerns following Time 1 screening are invited to complete a standardised psychometric assessment to recommend, implement and follow-up referral pathways with GPs and parents. (1c) automated email prompts will commence once the child reaches the appropriate age, to advise participants to complete ongoing WMG-I screens (aligned to the Personal Health Record schedule, aged 3, and 4). Step 1b above is repeated annually until the child reaches 4 years of age. Uptake of referrals will be logged by the GPs on a standard template and audited fortnightly by the research team. Online survey analytics will be used to ensure questionnaires are complete and send follow up emails for incomplete surveys. (2) At 2 years of age: all children who screen positive and a 10% random sample of screen negative cases identified from the initial screening process will be diagnostically assessed for developmental and behavioural outcomes by blinded assessors; in a face-to-face appointment at a local university site, or approved health care site such as a community health centre. Measures include Mullen Scale of Early Learning (MSEL), Vineland Adaptive Behavior Scales Third Edition (Vineland-3), and the Autism Diagnostic Observation Schedule Toddler Module (ADOS-2). The assessments will take 2-3 hours to complete. (3) At 3 years of age: all parents will receive an email alert to complete an online surveillance questionnaire about ongoing developmental surveillance, uptake on recommendations, service utilisation and parent satisfaction with services. This will take approximately 5 minutes to complete. (4) At 4 years of age: Step 3 will be repeated. All children will be assessed for Anxiety, Mood, and Disruptive Disorders via an email notification to complete the Strengths and Difficulties Questionnaire (SDQ) online, which takes approximately 10 minutes. In addition, parents of children who screened positive, as well as 10% of children who screened negative, in step 2 will receive an email alert to complete additional online questionnaires including the: Health Literacy Questionnaire (HLQ), K6, EQ5D5L and the Institute for Medical Technology Productivity Cost Questionnaire (iPCQ). Questionnaire completion will take approximately 30 minutes. The trial will take 5 years, with recruitment in the General Practice occurring during the first 12 months of the trial.


Locations(1)

NSW,QLD, Australia

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ACTRN12621000680864