ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001200178

Ethics application status

Approved

Date submitted

19/07/2019

Date registered

27/08/2019

Date last updated

19/03/2021

Date data sharing statement initially provided

27/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Early detection of autism in toddlers within General Practice in Australia

Scientific title

A multistate trial of an early surveillance program for autism within General Practices in Australia

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

GPSfA

Linked study record

Health condition

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

Autism

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: ASD (Autism Spectrum Disorder) surveillance pathway

Initially a parent of the participant aged between approximately 18 and 24 months will complete the following ‘surveillance’ instruments in the General Practice waiting room using either an online link on a tablet or on paper based questionnaires (if internet is not available): Participant Information and Consent form, brief demographics, Learn The Signs. Act Early (LTSAE) developmental check from Centres for Disease Control and Prevention (CDC), The Parents’ Evaluation of Developmental Status (PEDS) and the Quantitative Checklist for Autism in Toddlers-10 item (Q-CHAT-10). These questionnaires will take approximately 10-15 minutes.

Then during a consultation on the same day, the General Practitioner (GP) or Practice Nurse (PN) will complete a face to face observational ‘surveillance’ instrument: the Social Attention and Communication Surveillance – online (SACS Online), which takes approximately 3-5 minutes. The assessor completing the SACS Online (GP or PN) will be noted.

Parents of participants who are identified as 'at developmental risk' on both the LTSAE and PEDS or 'at risk' of autism using the SACS Online or Q-CHAT-10 will then complete the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE-2) which will take approximately 10 minutes to complete (there will be the option to complete this at home).

Participants identified 'at risk' on the ASQ:SE-2 or 'at risk' of autism on the SACS Online or Q-CHAT and 10% of those determined 'not at risk' (randomly selected) will be invited to undergo a “Gold Standard” diagnostic confirmation assessment at approximately 24 months of age. This assessment will take approximately 3-4 hours and will occur at the local university by research staff trained in the administration of the assessment, or at another approved location such as a community health centre. This assessment will include the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), the Autism Diagnostic Interview-Revised (ADI-R), Mullen Scales of Early Learning (MSEL) and the Vineland Adaptive Behavior Scales, Third Edition (VABS-3) (Parent/Caregiver form).
At 30 months of age the parents of all trial participants in both arms will complete the Social Responsiveness Scale (SRS-2) at home.

All components of the intervention will be provided individually.

GPs and PNs will undergo professional training on the surveillance program and the National Autism Guideline implementation. An eLearning program is available as an online educational resource designed to provide online training for GPs and PNs to carry out health and developmental screening and ongoing surveillance. The GP training will be available through RANZGP website as a 6 hour CPD for the full Personal Health Record checks from birth to start of school and a stand alone developmental surveillance module as a 1 hour CPD. The participating practices will be informed about the availability of the module.
As the training is delivered in an online format it can be freely accessed by the GPs and broken down into the intensity or dose that suits their schedule.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

Control: Surveillance as usual

General Practitioners will be asked to log the methods and tools by which they assessed children to be 'at developmental risk', and note referrals, using a standard template developed for the project.

Participants identified as 'at developmental risk' and 10% of those determined 'not at risk' (randomly selected) will be invited to undergo a “Gold Standard” diagnostic confirmation assessment at approximately 24 months of age. This assessment will take approximately 3-4 hours and will occur at the local university by research staff trained in the administration of the assessment, or at another approved location such as a community health centre. This assessment will include the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), the Autism Diagnostic Interview-Revised (ADI-R), Mullen Scales of Early Learning (MSEL) and the Vineland Adaptive Behavior Scales, Third Edition (VABS-3) (Parent/Caregiver form).
At 30 months of age the parents of all trial participants in both arms will complete the Social Responsiveness Scale (SRS-2) at home.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of children between 18 and 24 months identified as ‘at risk’ of developmental concerns or autism using the developmental surveillance assessments. The surveillance assessments included as a composite screen are Parents’ Evaluation of Developmental Status (PEDS), Learn The Signs. Act Early (LTSAE), Quantitative Checklist for Autism in Toddlers-10 item (Q-CHAT-10), Social Attention and Communication Surveillance – online (SACS Online), Ages and Stages Questionnaire: Social-Emotional, Second Edition (ASQ:SE-2).

Timepoint [1]

Baseline

Primary outcome [2]

The proportion of children previously identified as ‘at risk’ of developmental concerns or autism using the developmental surveillance assessments who are later diagnosed with autism using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).

Timepoint [2]

24 months of age

Secondary outcome [1]

The proportion of children aged 18-24 months attending a participating primary health care General Practice clinic during the study duration who complete the developmental surveillance assessments ('uptake').

This outcome will be assessed using General Practice records to identify the number of children between 18 and 24 months attending the practice during the study and the number of children who undergo the developmental surveillance assessments.

Timepoint [1]

Duration of study

Secondary outcome [2]

Timepoint [2]

24 months of age.

Secondary outcome [3]

The proportion assigned as 'at probable risk' of autism using the Social Responsiveness Scale, Second Edition (SRS-2), Preschool form (2.5 to 4.5 years) compared with the proportion of children who were diagnosed with autism using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).

Timepoint [3]

30 months of age

Secondary outcome [4]

To compare the intervention arm who received assessments and recommendations using the National Autism Guideline with those in the comparator arm who received routine care. This composite outcome will be assessed using a study-specific, written semi structured questionnaire to evaluate the uptake of recommendations from doctors at the baseline visit, experience of assessment/service use including National Disability Insurance Scheme (NDIS), disability supports, early intervention received and parental satisfaction with the services.

Timepoint [4]

30 months of age

Secondary outcome [5]

The proportion of children previously identified as ‘at risk’ of developmental concerns using the screening assessments who are later confirmed as being developmentally delayed using the Mullen Scales of Early Learning (MSEL)

Timepoint [5]

24 months of age

Secondary outcome [6]

The proportion of children previously identified as ‘at risk’ of developmental concerns using the screening assessments who are later confirmed as having developmental delays using the Vineland Adaptive Behavior Scales, Third Edition (VABS-3) (Parent/Caregiver form)

Timepoint [6]

24 months of age

Secondary outcome [7]

The proportion of children who received referrals following identification of at risk of developmental concerns or autism. GP Practice records will be used to determine those who received referrals.

Timepoint [7]

Baseline

Eligibility

Key inclusion criteria

Any toddler between the ages of approximately 18-24 months taken to their General Practitioner for any reason, including for an immunisation, will be part of the trial (a “universal approach”).
Parents of participating toddlers are also included for the purpose of completing screening instruments and questionnaires about their toddler, and an evaluation survey at follow-up when toddler is 30 months of age.

Minimum age

18 Months

Maximum age

No limit

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)

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

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

Recruiting

Date of first participant enrolment

Anticipated

29/08/2019

Actual

11/11/2019

Date of last participant enrolment

Anticipated

14/08/2021

Actual

Date of last data collection

Anticipated

14/08/2021

Actual

Sample size

Target

2400

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Autism Cooperative Research Centre (Autism CRC)

Address [1]

The University of Queensland
Long Pocket Precinct, Level 3, Foxtail Building
80 Meiers Road,
Indooroopilly Qld 4068

Country [1]

Australia

Primary sponsor type

Other

Name

Autism Cooperative Research Centre (Autism CRC)

Address

The University of Queensland
Long Pocket Precinct, Level 3, Foxtail Building
80 Meiers Road,
Indooroopilly Qld 4068

Country

Australia

Secondary sponsor category [1]

University

Name [1]

UNSW Sydney

Address [1]

Sydney NSW 2052

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

La Trobe University

Address [2]

Melbourne
Victoria 3086

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee B

Ethics committee address [1]

UNSW Sydney
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/04/2019

Ethics approval number [1]

Summary

Brief summary

This project will synergise and build on existing State and Federal programs to identify barriers and develop mechanisms for accurate early detection of developmental problems including autism spectrum disorders (ASD) in Australia. The project will also evaluate an integrated model of care for ASD surveillance within the primary care setting of General Practice followed by standardised assessment and care pathways incorporating the national guideline for the assessment and diagnosis of ASD in Australia (National Guideline) for further assessment and early intervention. Developed and published by Autism CRC with the support of the National Disability Insurance Agency, the National Guideline aims to create greater consistency in diagnostic practices across Australia.

Aims of the project
1. To work with key stakeholders to: 
(a) develop a method for ‘universal’ surveillance of ASD in 18- to 24-month-olds across Australia, and
(b) carry out a “real life” evaluation of a care pathway for children at ‘high likelihood’ for ASD using the National Guideline. 
2. To examine the Autism Surveillance Pathway (ASP) with regard to uptake and completion of the surveillance program and the accurate diagnosis of ASD against the current program (Surveillance as Usual [SaU]). 
3. To determine acceptability, feasibility, and effectiveness of this surveillance protocol. 

A major outcome of this project will be the cooperation of various agencies and organisations, which will enable the embedding of the surveillance program within the existing health system and facilitate the long-term sustainability of the program. In addition, this project will allow the evaluation of the National Guideline. Currently, many children are missing early intervention opportunities. In this regard, it is noteworthy that the mean age of diagnosis for ASD in Australia is 49 months which urgently requires addressing. This is in part due to the extremely low uptake of the existing surveillance programs contributing to lack of access and opportunity for early detection with flow on effect on delay in intervention and consequent long-term effects. The significance of the project is highlighted by the fact that there is escalating economic impact of ASD both from health care and from a socio-economic perspective. Early identification and early intervention can provide significant buffers to assist children with ASD to reach their optimum potential and enhance school readiness in addition to preventing the cascade of a negative developmental trajectory and these difficulties becoming entrenched with secondary consequences such as academic failure, school absence, social dysfunction and forensic involvement. Long term, this work will undoubtedly be of enormous benefit to not only children with ASD and their families, but also to the wider society in terms of increasing human capital and reducing health, social and economic impacts.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Valsamma Eapen

Address

Chair, Infant Child and Adolescent Psychiatry, University of New South Wales
Head, Academic Unit of Child Psychiatry, South West Sydney (AUCS)
Stream Director, Early Life Determinants of Health, Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
Director, Program 1, Co-operative Research Centre for Autism (CRC)
Director, BestSTART-SW (Systems Transformation and Research Translation - South West Sydney) Academic Unit
Level 1, 30 Botany Street, Randwick,
UNSW Sydney 2052

Country

Australia

Phone

+61 02 9616 4205

Fax

v.eapen@unsw.edu.au

Contact person for public queries

Name

Josephine Barbaro

Address

Senior Research Fellow
Olga Tennison Autism Research Centre
School of Psychology and Public Health
College of Science, Health, and Engineering
La Trobe University
Melbourne, Victoria, 3083

Country

Australia

Phone

+61 03 94791283

Fax

J.Barbaro@latrobe.edu.au

Contact person for scientific queries

Name

Valsamma Eapen

Address

Country

Australia

Phone

+61 02 96164205

Fax

v.eapen@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3260	Ethical approval					377989-(Uploaded-19-07-2019-08-52-47)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A Multistate Trial of an Early Surveillance Program for Autism Within General Practices in Australia.	2021	https://dx.doi.org/10.3389/fped.2021.640359
Embase	Parental experience of an early developmental surveillance programme for autism within Australian general practice: A qualitative study.	2022	https://dx.doi.org/10.1136/bmjopen-2022-064375

N.B. These documents automatically identified may not have been verified by the study sponsor.

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