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Trial registered on ANZCTR


Registration number
ACTRN12618001574235
Ethics application status
Approved
Date submitted
16/09/2018
Date registered
20/09/2018
Date last updated
22/08/2019
Date data sharing statement initially provided
22/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The 'Watch Me Grow’ App (WMG) for identification of developmental and mental health problems in 1-2 year old children: a validation study
Scientific title
The 'Watch Me Grow’ App (WMG) for identification of developmental and mental health problems in 1-2 year old children: a validation study
Secondary ID [1] 296097 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood developmental delay 309676 0
Autism 309677 0
Condition category
Condition code
Mental Health 308478 308478 0 0
Autistic spectrum disorders
Mental Health 308500 308500 0 0
Other mental health disorders
Mental Health 308501 308501 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A cohort of parents and children aged approximately 18 months of age will complete the 'Watch Me Grow' (WMG) App on an ipad while in the waiting room before an immunisation/ Personal Health Record (PHR) appointment with a General Practitioner (GP) or Child and Family Health Nurse (CFHN).

The WMG app assessment consists of 8 questions to assess overall development (taken from the CDC ‘Learn the Signs Act Early’ items) and a 10-item Quick Checklist for Autism in Toddlers (QCHAT). In total, the WMG app takes approximately 5 minutes to complete. Immediately on completing the WMG app, the GP/CFHN will receive an email summary of the screening results, referral recommendations/pathways to inform the family’s management plan.

All children identified through the WMG app as being at developmental risk together with 10% of those who screen negative (to cover for any false negative results), will complete a comprehensive gold-standard developmental assessment protocol at 2 years of age. Follow up will also involve questions to ascertain the uptake of referral recommendations made by the GP/CFHN during the 18-month consultation.
Intervention code [1] 312437 0
Early detection / Screening
Comparator / control treatment
A gold-standard developmental assessment protocol is being used as the comparator/control at 2 years of age. The assessment protocol will include the following validated measures:
• Autism Diagnostic Observation Schedule Toddler Module (ADOS; Luyster et al.,
2009), the only tool that provides a semi-structured direct assessment of the child‘s social and communication skills and behaviour. It is considered to be a gold-standard measurement tool for ASD. Vineland Social-Emotional Early Childhood Scales (Cicchette & Sparrow, 1998)
• Ages and Stages Questionnaire - Social Emotional scale (ASQ-SE; Squires et al, 2009), a parent-report screening tool designed to identify children who may be at risk for social or emotional difficulties.
• Mullen Scale of Early Learning (MSEL; Mullen, 1995) a standardised measure of nonverbal and verbal development in children from birth through to 68 months of age. Five developmental domains are assessed, including gross motor, fine motor, visual reception, receptive language, and expressive language, and standard scores and age equivalents are provided. The test takes 15 minutes to complete and has sound reliability and validity.
• Vineland Social-Emotional Early Childhood Scales (VSEECS; Cicchette & Sparrow, 1998), a standardised, norm-referenced evaluation tool for children from birth to age six. Parental interview assesses a young child's social and emotional function, such as ability to pay attention, to enter into intentional social interactions, and to develop self-regulating behaviours. It is widely used to ascertain functional level.
• Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP; Johnson et al., 1999), a parent-report interview designed to diagnose DSM disorders in children and adolescents.
Control group
Active

Outcomes
Primary outcome [1] 307458 0
Autism diagnosis, as assessed using the Autism Diagnostic Observation Schedule Toddler Module (ADOS; Luyster et al., 2009).
Timepoint [1] 307458 0
Child age 18 months, child age 24 months (primary outcome time point)
Primary outcome [2] 307459 0
Child developmental status as assessed via the Mullen Scale of Early Learning (MSEL; Mullen, 1995)
Timepoint [2] 307459 0
Child age 18 months, child age 24 months (primary outcome time point)
Primary outcome [3] 307460 0
Child behavioural issues as assessed using the Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP)
Timepoint [3] 307460 0
Child age 18 months, child age 24 months (primary outcome time point)
Secondary outcome [1] 351971 0
Child adaptive functioning as assessed using the Vineland Social-Emotional Early Childhood Scales (Cicchette & Sparrow, 1998)
Timepoint [1] 351971 0
Child age 18 months, child age 24 months

Eligibility
Key inclusion criteria
Child aged 18 months, presenting with their parent for an appointment at a participating GP or CFHN clinic; Parent literate in the English language
Minimum age
18 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent not proficient in the English language

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All children identified at 18-months through the WMG app as being at developmental risk together with 10% of those who screen negative (to cover for any false negative results), will complete the comprehensive gold-standard developmental/behavioural assessment protocol at 2 years of age.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sensitivity, specificity, negative and positive predictive values, misclassification rates and optimal cut-offs for accuracy using the WMG app will be determined by examining Receiver Operating Characteristics (utilizing a 95% CI and assuming a sensitivity of 80%). The sample size will be powered to detect impairment rates of at least 10% in the study population with accuracy (power = 80%, alpha = 0.05).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
24/09/2018
Actual
5/09/2018
Date of last participant enrolment
Anticipated
1/07/2019
Actual
14/08/2019
Date of last data collection
Anticipated
27/01/2020
Actual
Sample size
Target
240
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27631 0
2567 - Narellan
Recruitment postcode(s) [2] 27632 0
2570 - Oran Park

Funding & Sponsors
Funding source category [1] 300684 0
Charities/Societies/Foundations
Name [1] 300684 0
Clive and Vera Ramaciotti Foundations
Country [1] 300684 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 300213 0
None
Name [1] 300213 0
Address [1] 300213 0
Country [1] 300213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301466 0
South Western Sydney Local Health District Human Research Ethics Committee (EC00136)
Ethics committee address [1] 301466 0
Ethics committee country [1] 301466 0
Australia
Date submitted for ethics approval [1] 301466 0
31/03/2017
Approval date [1] 301466 0
01/06/2017
Ethics approval number [1] 301466 0
HREC/17/LPOOL/150; HE17/081

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

Contacts
Principal investigator
Name 87106 0
Dr Jane Kohlhoff
Address 87106 0
University of New South Wales
C/O Karitane
P.O. Box 241, Villawood
NSW 2163
Country 87106 0
Australia
Phone 87106 0
+61 02 9794 2344
Fax 87106 0
Email 87106 0
Jane.Kohlhoff@unsw.edu.au
Contact person for public queries
Name 87107 0
Jane Kohlhoff
Address 87107 0
University of New South Wales
C/O Karitane
P.O. Box 241, Villawood
NSW 2163
Country 87107 0
Australia
Phone 87107 0
+61 02 9794 2344
Fax 87107 0
Email 87107 0
Jane.Kohlhoff@unsw.edu.au
Contact person for scientific queries
Name 87108 0
Jane Kohlhoff
Address 87108 0
University of New South Wales
C/O Karitane
P.O. Box 241, Villawood
NSW 2163
Country 87108 0
Australia
Phone 87108 0
+61 02 9794 2344
Fax 87108 0
Email 87108 0
Jane.Kohlhoff@unsw.edu.au

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.