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Trial registered on ANZCTR


Registration number
ACTRN12621001433897
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
25/10/2021
Date last updated
25/10/2021
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of Autism in Children (SOUND)
Scientific title
The effect of different service models on quality of care in the assessment of Autism Spectrum Disorder in children: a multi-centre randomised controlled trial.
Secondary ID [1] 305080 0
Nil
Universal Trial Number (UTN)
Trial acronym
SOUND study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323300 0
Condition category
Condition code
Mental Health 320865 320865 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Allied health first contact model. Children will be receive assessments from a team of allied health professionals before seeing a Paediatrician for confirmation of the presence/absence of an ASD diagnosis.

Assessments may include one or more of the following: Child Behaviour Checklist (Parent-Reported), Child Behaviour Checklist (Teacher-Reported, where possible). Vineland Adaptive Behaviour Scale, Ages and Stages Questionnaire, Pragmatics Profile for Everyday Communication, Childhood Autism Rating Scale, Autism Diagnostic Observation Scale (version 2), Sensory Profile 2, Clinical Evaluation of Language Fundamentals (5th Edition), Clinical Evaluation of Language Fundamentals (Preschool, 2nd Edition), Wechsler Preschool and Primary Scale of Intelligence (4th Edition), Wechsler Intelligence Scale for Children (5th Edition), Social Communication Questionnaire (SCQ).

The type and number of assessments completed will be based on clinician judgement based on the clinical presentation of each participant. Assessments may be 1:1 face to face standardised assessments and/or involve semi-structured interviews either face to face, over the phone or via telehealth. Assessment sessions are typically scheduled for 60 minutes and frequency of assessment sessions will be at least one or more weeks apart, dependent on clinician, participant and caregiver availability.

After the allied health assessments are completed, the Paediatrician appointment will be scheduled at the next available clinical slot, as determined by the children's outpatient clinic coordinator. Scheduling of the Paediatrician appointment will vary between facilities and are contingent on existing organisational priorities for urgent versus non-urgent care. Timing of the Paediatrician appointment, however, will always follow on from the completion of Allied Health appointments. Paediatricians will diagnose the presence/absence of ASD according to the DSM-V criteria with all relevant information collected at the time of face to face or telehealth consultation with the participant and/or caregiver.

The Research Officer will be responsible for the adherence of Allied Health versus Paediatrician appointment ordering throughout the trial via hospital based appointment systems. It is estimated that each participant will require multiple appointments with the Allied Health team for the completion of relevant assessments, ranging between 2 to 12 one hour long appointments.

Intervention code [1] 321475 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator group: Paediatrician first contact model. Children will be seeing a Paediatrician first, then referred to allied health professionals for assessments. Once all assessments by the allied health professionals are completed, children will see a Paediatrician for the confirmation of the presence/absence of an ASD diagnosis.

Paediatrician appointments will be between 30 to 60 minutes in duration and completed via face to face, telehealth or phone review depending on COVID-19 pandemic requirements for service delivery. Scheduling of the Paediatrician appointment will vary between facilities and are contingent on existing organisational priorities for urgent versus non-urgent care. Timing of the Paediatrician appointment, however, will always occur before any Allied Health appointments. Paediatricians will diagnose the presence/absence of ASD according to the DSM-V criteria with all relevant information collected at the time of face to face or telehealth consultation with the participant and/or caregiver. This may occur at the first initial appointment with the Paediatrician or at subsequent appointments with the Paediatrician, depending on the availability of enough information for the diagnosis of the presence of ASD according to the DSM-V criteria.

Scheduling of Allied Health appointments following the first Paediatrician appointment will occur, as per usual clinical processes across sites. Allied Health initial appointments relative to the first Paediatrician contact will vary between facilities and are contingent on existing organisational priorities for urgent versus non-urgent care.

The Research Officer will be responsible for the adherence of Allied Health versus Paediatrician appointment ordering throughout the trial via hospital based appointment systems. It is estimated that each participant will require multiple appointments with the Allied Health team for the completion of relevant assessments, ranging between 2 to 12 one hour long appointments. It is estimated that each participant will require between 1 to 3 separate appointments (overall between 30 to 120 minutes) with the Paediatrician over a period of 3-6 months, depending on the clinical presentation of each participant.

Control group
Active

Outcomes
Primary outcome [1] 328658 0
The child's quality of life assessed by the Pediatric Quality of Life Inventory (PedsQL)
Timepoint [1] 328658 0
Baseline and at final Paediatrician appointment (within 7 days of appointment where presence/absence of ASD diagnosis was made).
Primary outcome [2] 328899 0
The child's quality of life assessed by the European Quality of Life Five Dimension Youth Version (EQ-5D-Y).
Timepoint [2] 328899 0
Baseline and at final Paediatrician appointment (within 7 days of appointment where presence/absence of ASD diagnosis was made).
Primary outcome [3] 328900 0
The Autism Family Experience Questionnaire (AFEQ)
Timepoint [3] 328900 0
Baseline and at final Paediatrician appointment (within 7 days of appointment where presence/absence of ASD diagnosis was made).
Secondary outcome [1] 399850 0
Parent perceptions of health service assessed by the Measure of Processes of Care.

Timepoint [1] 399850 0
Baseline and at final Paediatrician appointment (within 7 days of appointment where presence/absence of ASD diagnosis was made).
Secondary outcome [2] 400824 0
Healthcare service costs - assessed as a composite of hospital admission, allied health and specialist outpatient appointment costs
Timepoint [2] 400824 0
Extracted from hospital systems at the conclusion of the study (i.e. when the last participant completes study end point).
Secondary outcome [3] 400825 0
Consumer costs - assessed as a composite of patient (family) travel and time off work to attend appointments.
Timepoint [3] 400825 0
This data will be collected at each Allied Health or Paediatrician appointment from the caregiver (+/- 48 hours either side of the appointment).
Secondary outcome [4] 401638 0
Total number of days from GP referral date to medical appointment date where presence/absence of ASD diagnosis is made.
Timepoint [4] 401638 0
Extracted from hospital systems at the conclusion of the study (i.e. when the last participant completes the study end point).

Eligibility
Key inclusion criteria
• Referred for cognitive, behavioural, learning or developmental assessment; and
• Triaging team determine assessment of ASD is warranted as part of differential diagnosis.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Children with >2 allied health assessments completed in past 12 months
• Children in out of home care
• Previous diagnosis of ASD
• Acute functional deterioration requiring medical review

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)
Model of care allocation (allied health versus medical first pathway) will be concealed in sequentially numbered opaque envelopes and assigned to enrolled children by a clinic nurse independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list, created by an independent biostatistician will be used. Block size permutation of n=5 will be utilized to ensure equal distribution of participants into each pathway.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and statistical power
Accepting an alpha risk of <0.05, a beta risk of < 0.2 and assuming a 10% risk of dropout during follow-up, n=26 patients in each group is required to identify a statistically significant reduction of at least one medical appointment between groups.

Statistical methods
The economic evaluation will take the form of a cost-consequence analysis, where descriptive statistics will be used to summarise differences across a number of resource use and cost items between the two treatment groups. This type of economic evaluation design was chosen to reflect the nature of this intervention where improvements are expected to be seen across a range of cost and patient outcomes (including patient out of pocket cost, health system cost, patient satisfaction and patient QoL). The cost-consequence analysis design allows for these to be reported clearly and transparently so that decision makers can come to their own conclusions about the value of this service change. Specific cost categories will include allied health and specialist outpatient appointment costs, as well as hospital admissions costs and costs of patient (family) travel and time off work to attend appointments.

To account for clustering at the hospital level and repeated measures over time, multivariable mixed-effects regression models will be built to estimate the interventional effect between and within groups. For each model building process, variables found to be significantly associated with the outcome measure in the univariable analysis at the 10% level will be retained in the final model. As the primary predictor of interest, intervention effect will be forced into the multivariable model. Continuous outcome measures will be analysed using linear regression models. For dichotomous measures, the analysis will be by binary logistic regression, while multinomial logistic regression will be used to analyse nominal measures. Model diagnostics will be conducted on all models to ascertain their appropriateness. Each model will be tested for violations of model assumptions, the existence of influential points and goodness of fit. Tests for all outcomes will be two-tailed, with levels of statistical significance set at 5%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20298 0
Caboolture Hospital - Caboolture
Recruitment hospital [2] 20299 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 35039 0
4510 - Caboolture
Recruitment postcode(s) [2] 35040 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 309479 0
Government body
Name [1] 309479 0
Allied Health Professions' Office of Queensland, Queensland Health
Country [1] 309479 0
Australia
Primary sponsor type
Individual
Name
Dr Thuy Frakking
Address
7 Morayfield Rd,
Riverside Offices
Caboolture Hospital
Caboolture, QLD, 4510.
Country
Australia
Secondary sponsor category [1] 310451 0
None
Name [1] 310451 0
Address [1] 310451 0
Country [1] 310451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309266 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309266 0
Ethics committee country [1] 309266 0
Australia
Date submitted for ethics approval [1] 309266 0
Approval date [1] 309266 0
18/08/2021
Ethics approval number [1] 309266 0
HREC/21/QCHQ/77040

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

Contacts
Principal investigator
Name 113554 0
Dr Thuy Frakking
Address 113554 0
7 Morayfield Rd
Riverside Offices
Caboolture Hospital
Caboolture, QLD, 4510
Country 113554 0
Australia
Phone 113554 0
+61 422060947
Fax 113554 0
Email 113554 0
thuy.frakking@health.qld.gov.au
Contact person for public queries
Name 113555 0
Thuy Frakking
Address 113555 0
7 Morayfield Rd
Riverside Offices
Caboolture Hospital
Caboolture, QLD, 4510
Country 113555 0
Australia
Phone 113555 0
+61 422060947
Fax 113555 0
Email 113555 0
thuy.frakking@health.qld.gov.au
Contact person for scientific queries
Name 113556 0
Thuy Frakking
Address 113556 0
7 Morayfield Rd
Riverside Offices
Caboolture Hospital
Caboolture, QLD, 4510
Country 113556 0
Australia
Phone 113556 0
+61 422060947
Fax 113556 0
Email 113556 0
thuy.frakking@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data sharing not included in approved ethics submission for the study.


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
EmbaseThe effect of different service models on quality of care in the assessment of autism spectrum disorder in children: study protocol for a multi-centre randomised controlled trial.2022https://dx.doi.org/10.1186/s12887-022-03244-y
N.B. These documents automatically identified may not have been verified by the study sponsor.