Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000680864
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
3/06/2021
Date last updated
1/09/2024
Date data sharing statement initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
"Watch Me Grow Integrated approach - WMG- I”: A web-based developmental surveillance approach for uptake of childhood screening and intervention
Scientific title
“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
Secondary ID [1] 303104 0
None
Universal Trial Number (UTN)
Trial acronym
WMG-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child developmental disorders 320196 0
Underused child health services 320267 0
Condition category
Condition code
Public Health 318141 318141 0 0
Health service research
Public Health 318142 318142 0 0
Health promotion/education
Mental Health 318199 318199 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319408 0
Early detection / Screening
Intervention code [2] 320481 0
Treatment: Other
Comparator / control treatment
Control: Surveillance as Usual (SaU) Cluster, routine developmental surveillance as indicated by State-based recommendations conducted by the GP practice.

Parents/caregivers of 18-month old children (range 16 to 35-months) will receive the “care as usual” developmental surveillance provided by their GP service. GPs will be asked to record their surveillance procedure (screens and results, referrals or recommendations provided to families) using a standard template developed for the project.

Children that GPs identify at the 18-month as having a "developmental concern" and a 10% random sample with "no developmental concern" will be invited to undergo a diagnostic assessment 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. Following the same procedure as the WMG-I Group 2-year assessment, children will be assessed using the 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.
Control group
Active

Outcomes
Primary outcome [1] 326119 0
Developmental surveillance completion rates at 18 months. Website analytics will be used to define the proportion of children completing the developmental surveillance check using the WMG-I weblink (PEDS, LTSAE, Q-CHAT-10 and or, ASQ-3 and uptake of any referral) or SaU GP screening routine (any screens and referral uptake).
Timepoint [1] 326119 0
18-months of age (16 to 35-months)
Primary outcome [2] 326120 0
Developmental surveillance completion rates at 3 and 4 years of age. Website analytics will be used to define the proportion of children completing the developmental surveillance checks using the WMG-I weblink (developmental surveillance questionnaire and uptake of any referral) or SaU GP screening routine (any screens and referral uptake).
Timepoint [2] 326120 0
3 and 4 years
Secondary outcome [1] 390194 0
Diagnostic accuracy (sensitivity, specificity, PPV, NPV, PLR and NLR all with 95% CI) of the WMG-I and the SaU screening procedures to discriminate between Global Developmental Disability and Behavioural Disability (Autism) at 2 years (in all 18-months screen positives and a 10% sample of screen negatives). Disability defined as -2SD below the mean on any measure for Developmental Global Disability using the MSEL and VABS and Behavioural disability-specifically autism ADOS-2 using standard cut-offs of -2SD below the mean. Screening disability defined as “failed scores" according to standardised scores/manuals reported for Developmental Global Disability using PEDS or LTASE or ASQ-3 and for Behavioural Disability (Autism) using QCHAT and ASQ-3
Timepoint [1] 390194 0
2 years of age
Secondary outcome [2] 390195 0
Proportion of parents with high score satisfaction with child surveillance.

Defined as the proportion of "yes" vs. "no" or "unsure" on a study specific questionnaire.
Timepoint [2] 390195 0
4 years of age
Secondary outcome [3] 390196 0
Proportion of parents with highly scored child development health literacy.

Defined as the proportion of ‘strongly agree’, ‘agree’, vs. ‘disagree’ or ‘strongly disagree’ Measured by the HLQ for each of the nine domains.
Timepoint [3] 390196 0
4 years of age
Secondary outcome [4] 390197 0
Proportion of GPs that demonstrate high satisfaction themes assessed in focus groups/interviews with GPs regarding program uptake and referral recommendations in WMG-I vs. SaU.
Timepoint [4] 390197 0
4 years of age
Secondary outcome [5] 390198 0
Proportion of children diagnosed with behavioural disorders based on DISCAP results.

Defined by a two-step procedure where all children are screened with SDQ and those who fail are diagnostically assessed using the DISCAP and corresponding DSM V criteria.
Timepoint [5] 390198 0
4 years of age.
Secondary outcome [6] 390199 0
The impact of the intervention on health utility of parents/guardian measured using the EQ5D5L, a generic health-related quality of life questionnaire. This converts responses to five dimensions of health, each with five possible responses, into a single summary statistic of overall health.
Timepoint [6] 390199 0
When the child reaches 4 years of age.
Secondary outcome [7] 393511 0
Impact of the intervention on parental/guardian productivity and the associated costs, measured using the Institute for Medical Technology’s, Productivity Cost Questionnaire (iPCQ). This includes: absenteeism, presenteeism and unpaid work.
Timepoint [7] 393511 0
When the child reaches 4 years of age.

Eligibility
Key inclusion criteria
GP practices in the trial sites that offer child immunisation and have the capacity to recruit approximately 50 children in one year.
Children and their parents/caregivers presenting at participating GP practices for 18-months (range: 16 to35-months) child immunisation or other health care needs.
Minimum age
16 Months
Maximum age
5 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)
Once GPs provide written informed consent, a statistician will randomly allocate GP practices to either the intervention or control cluster using a computer-generated random number process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A minimisation randomisation procedure, stratified by location (NSW, QLD) and GP practice size (less than 4 GPs, 4 or more GPs) will randomise GP practices in a 1:1 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
Statistical methods / analysis
Based on our previous work we estimate that by 5 years of age 10% of children will have completed their state-based child developmental screening surveillance schedule. We have postulated that the WMG-I intervention may improve these rates to 50%.

A sample size of 2000 children from two clusters (40 GP Practices in total) with approximately 50 children per site, yielding 80% or greater power to detect an increase of 50% increase in completed surveillance at each of the 18-months, 3 and 4 year time points, with a 0.65 coefficient of variation, ICC of 0.01. The test statistic used is the two-sided Z test (pooled). The significance level of the test was 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/06/2021
Actual
26/04/2022
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
686
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 307508 0
Government body
Name [1] 307508 0
National Health and Medical Research Council
Country [1] 307508 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney (UNSW)
Address
UNSW Sydney Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 308188 0
University
Name [1] 308188 0
University of Queensland
Address [1] 308188 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 308188 0
Australia
Secondary sponsor category [2] 309671 0
Government body
Name [2] 309671 0
South Western Sydney Local Health District
Address [2] 309671 0
South Western Sydney Local Health District Executive Office
Locked Bag 7279, LIVERPOOL BC, NSW, 1871
Country [2] 309671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307581 0
South Western Sydney Local Health District Research Ethics Committee
Ethics committee address [1] 307581 0
Ethics committee country [1] 307581 0
Australia
Date submitted for ethics approval [1] 307581 0
12/11/2020
Approval date [1] 307581 0
18/11/2020
Ethics approval number [1] 307581 0
2020/ETH01625

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

Contacts
Principal investigator
Name 107750 0
Prof Valsamma Eapen
Address 107750 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital,
Elizabeth Street, Liverpool, NSW 2170
Country 107750 0
Australia
Phone 107750 0
+61 0296164205
Fax 107750 0
Email 107750 0
[email protected]
Contact person for public queries
Name 107751 0
Valsamma Eapen
Address 107751 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital,
Elizabeth Street, Liverpool, NSW 2170
Country 107751 0
Australia
Phone 107751 0
+61 0296164205
Fax 107751 0
Email 107751 0
[email protected]
Contact person for scientific queries
Name 107752 0
Valsamma Eapen
Address 107752 0
ICAMHS, L1 Mental Health Centre, Liverpool Hospital,
Elizabeth Street, Liverpool, NSW 2170
Country 107752 0
Australia
Phone 107752 0
+61 0296164205
Fax 107752 0
Email 107752 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
SourceTitleYear of PublicationDOI
EmbaseWatch me grow integrated (WMG-I): protocol for a cluster randomised controlled trial of a web-based surveillance approach for developmental screening in primary care settings.2022https://dx.doi.org/10.1136/bmjopen-2022-065823
N.B. These documents automatically identified may not have been verified by the study sponsor.