Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000498796
Ethics application status
Approved
Date submitted
11/03/2022
Date registered
29/03/2022
Date last updated
10/07/2023
Date data sharing statement initially provided
29/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic Accuracy and economic value of a Tiered Assessment (DATA) for Fetal Alcohol Spectrum Disorder (FASD)
Scientific title
Diagnostic Accuracy and economic value of a Tiered Assessment (DATA) for Fetal Alcohol Spectrum Disorder (FASD) in urban, rural, and remote Australia
Secondary ID [1] 306643 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DATAforFASD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Alcohol Spectrum Disorder 325586 0
Condition category
Condition code
Neurological 322951 322951 0 0
Other neurological disorders
Mental Health 322952 322952 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Each participant will receive both a rapid and a comprehensive assessment of 9 neurodevelopmental domains: (motor, cognition, language, academic achievement, memory, attention, executive function, affect regulation, and adaptive function). Assessments will be delivered by appropriately trained health practitioners (e.g., speech pathologists, psychologists, paediatricians, general practitioners). Assessments will be delivered face-to-face where possible; tele-health appointments will be used when face-to-face appointments are not possible. Assessments for all domains will not be completed during one sitting. Participants will attend multiple sessions to complete all index and reference tests. All tests will be completed within 6 months of the first administered test. Assessments will be conducted at specialist clinics and primary care clinics in both urban and rural/remote settings. The anticipated duration of testing for all rapid tests will be about 1 hr. The anticipated duration of testing for all comprehensive tests will be about 8-10 hours.
Intervention code [1] 323095 0
Diagnosis / Prognosis
Intervention code [2] 323096 0
Early Detection / Screening
Comparator / control treatment
No control group is used. Rapid assessments (index tests) for each child will be compared to standardised, reliable and valid comprehensive assessments (reference tests) administered to the same child for nine neurodevelopmental domains. Index and reference tests will be compared to determine the accuracy of index tests in: (1) identifying impairment in each domain; and (2) diagnosing FASD.

Index tests:
Rapid Neurodevelopmental Assessment: Australian Edition (RNDA ): motor, cognition, language, memory, attention, affect regulation, adaptive behavior
Behavior Assessment System for Children, 3rd Edition (BASC-3 ): academic achievement, attention, affect regulation, executive function, adaptive behaviour

Reference tests:
- Movement Assessment Battery for Children: 2nd Edition (M-ABC 2 ) or Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2): motor
- Wechsler Intelligence Scale for Children, Version 5 (WISC-V), Australian and New Zealand Standardised Edition: cognition
- Clinical Evaluation of Language Fundamentals, Version 5 (CELF-5) or equivalent language assessment validated for an Aboriginal and Torres Strait Islander population: language
- Wechsler Individual Achievement Test, 3rd Edition (WIAT-III) or Wide Range Achievement Test, 5th Edition (WRAT-5 ) or Woodcock-Johnson Achievement Test, 4th Edition, Australasian Adaptation: academic achievement
- Children’s Memory Scale (CMS): memory
- Connors, 3rd Edition: attention
- Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF–2): executive function
- Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) or Vineland Adaptive Behavior Scales, Third Edition (Vineland-3): adaptive behavior
Control group
Active

Outcomes
Primary outcome [1] 330724 0
Rapid assessments (index tests) will be compared to standardised, reliable and valid comprehensive assessments (reference tests), across nine neurodevelopmental domains. Index and reference tests will be compared to determine the accuracy of index tests in diagnosing FASD. All index and reference test scores will be assessed in combination to determine the diagnostic status of FASD. Index tests: Rapid Neurodevelopmental Assessment: Australian Edition (RNDA ) Behavior Assessment System for Children, 3rd Edition (BASC-3 ) Reference tests: - Movement Assessment Battery for Children: 2nd Edition (M-ABC 2 ) or Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2) - Wechsler Intelligence Scale for Children, Version 5 (WISC-V), Australian and New Zealand Standardised Edition - Clinical Evaluation of Language Fundamentals, Version 5 (CELF-5) or equivalent language assessment validated for an Aboriginal and Torres Strait Islander population - Wechsler Individual Achievement Test, 3rd Edition (WIAT-III) or Wide Range Achievement Test, 5th Edition (WRAT-5 ) or Woodcock-Johnson Achievement Test, 4th Edition, Australasian Adaptation - Children’s Memory Scale (CMS) - Connors, 3rd Edition - Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF – 2) - Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) or Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Timepoint [1] 330724 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Primary outcome [2] 330725 0
Index tests (RNDA gross and fine motor subscale) will be compared to standardised, reliable and valid reference tests [Movement Assessment Battery for Children: 2nd Edition (M-ABC 2 ) or Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2)] to determine the accuracy of index tests in identifying impairment in the motor domain of neurodevelopment. The gross and fine motor index subscales will be analysed as a composite for motor impairment.
Timepoint [2] 330725 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Primary outcome [3] 330773 0
Index tests (RNDA cognition subscale) will be compared to standardised, reliable and valid reference tests [Wechsler Intelligence Scale for Children, Version 5 (WISC-V), Australian and New Zealand Standardised Edition] to determine the accuracy of index tests in identifying impairment in the cognition domain of neurodevelopment.
Timepoint [3] 330773 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [1] 407323 0
Primary Outcome 4:
Index tests (RNDA language subscale) will be compared to standardised, reliable and valid reference tests [Clinical Evaluation of Language Fundamentals, Version 5 (CELF-5) or equivalent language assessment validated for an Aboriginal and Torres Strait Islander population] to determine the accuracy of index tests in identifying impairment in the language domain of neurodevelopment.
Timepoint [1] 407323 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [2] 407343 0
Primary Outcome 5:
Index tests (BASC-3 learning problems scale) will be compared to standardised, reliable and valid reference tests [Wechsler Individual Achievement Test, 3rd Edition (WIAT-III) or Wide Range Achievement Test, 5th Edition (WRAT-5 ) or Woodcock-Johnson Achievement Test, 4th Edition, Australasian Adaptation ] to determine the accuracy of index tests in identifying impairment in the academic achievement domain of neurodevelopment.
Timepoint [2] 407343 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [3] 407344 0
Primary Outcome 6:
Index tests (RNDA: memory subscale) will be compared to standardised, reliable and valid reference tests [Children’s Memory Scale (CMS)] to determine the accuracy of index tests in identifying impairment in the memory domain of neurodevelopment.
Timepoint [3] 407344 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [4] 407345 0
Primary Outcome 7:
Index tests (BASC-3: Attention Problems clinical scale] will be compared to standardised, reliable and valid reference tests (Connors, 3rd Edition) to determine the accuracy of index tests in identifying impairment in the attention domain of neurodevelopment.
Timepoint [4] 407345 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [5] 407346 0
Primary Outcome 8:
Index tests (BASC-3: Executive Functioning Index score) will be compared to standardised, reliable and valid reference tests [Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF – 2)] to determine the accuracy of index tests in identifying impairment in the executive function domain of neurodevelopment.
Timepoint [5] 407346 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [6] 407519 0
Primary Outcome 9:
Index tests (BASC-3: Anxiety and Depression clinical scale] will be compared to standardised, reliable and valid reference tests [Previous diagnostic status (depression / anxiety)] to determine the accuracy of index tests in identifying impairment in the affect regulation domain of neurodevelopment.
Timepoint [6] 407519 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [7] 407520 0
Primary Outcome 10: Index tests (RNDA: Self care subscale) will be compared to standardised, reliable and valid reference tests [Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) or Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)] to determine the accuracy of index tests in identifying impairment in the Adaptive Behavior domain of neurodevelopment.
Timepoint [7] 407520 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [8] 407521 0
Secondary Outcome 1: Diagnostic accuracy of index tests in diagnosing other neurodevelopmental disorders of childhood that can either co-occur with FASD, or occur independently, such as attention-deficit hyperactivity disorders and autism spectrum disorders. All index and reference test scores will be assessed in combination to determine the diagnostic status of other disorders. Index tests: Rapid Neurodevelopmental Assessment: Australian Edition (RNDA ) Behavior Assessment System for Children, 3rd Edition (BASC-3 ) Reference tests: - Movement Assessment Battery for Children: 2nd Edition (M-ABC 2 ) or Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2) - Wechsler Intelligence Scale for Children, Version 5 (WISC-V), Australian and New Zealand Standardised Edition - Clinical Evaluation of Language Fundamentals, Version 5 (CELF-5) or equivalent language assessment validated for an Aboriginal and Torres Strait Islander population - Wechsler Individual Achievement Test, 3rd Edition (WIAT-III) or Wide Range Achievement Test, 5th Edition (WRAT-5 ) or Woodcock-Johnson Achievement Test, 4th Edition, Australasian Adaptation - Children’s Memory Scale (CMS) - Connors, 3rd Edition - Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF – 2) - Adaptive Behavior Assessment System, 3rd Edition (ABAS-3) or Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Timepoint [8] 407521 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [9] 407522 0
Secondary Outcome 2:
The direct healthcare costs of index tests will be compared to reference tests.
Timepoint [9] 407522 0
Healthcare costs will be collected by survey at the conclusion of index and reference tests. This survey was designed specifically for the study.
Secondary outcome [10] 407523 0
Secondary Outcome 3:
The indirect cost savings associated with diagnosing FASD using index tests will be compared to reference tests.
Timepoint [10] 407523 0
Healthcare costs will be collected by survey at the conclusion of index and reference tests. This survey was designed specifically for the study.
Secondary outcome [11] 407524 0
Secondary Outcome 4:
The direct healthcare costs for index tests and reference tests being delivered in primary healthcare settings will be compared to specialist clinic settings.
Timepoint [11] 407524 0
Healthcare costs will be collected by survey at the conclusion of index and reference tests. This survey was designed specifically for the study.
Secondary outcome [12] 407525 0
Secondary Outcome 5:
The indirect cost savings of completing index tests and reference tests in primary healthcare settings will be compared to specialist clinic settings.
Timepoint [12] 407525 0
Healthcare costs will be collected by survey at the conclusion of index and reference tests. This survey was designed specifically for the study.
Secondary outcome [13] 407967 0
Index tests (BASC-3: Adaptive Skills composite) will be compared to standardised, reliable and valid reference tests [Adaptive Behavior Assessment System, 3rd Edition (ABAS-3)] to determine the accuracy of index tests in identifying impairment in the Adaptive Behavior, social skills and social communication domain of neurodevelopment.
Timepoint [13] 407967 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [14] 407968 0
Index tests [RNDA: Behavior subscale (attention items)] will be compared to standardised, reliable and valid reference tests (Connors, 3rd Edition) to determine the accuracy of index tests in identifying impairment in the attention domain of neurodevelopment.
Timepoint [14] 407968 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.
Secondary outcome [15] 407969 0
Index tests [RNDA: Behavior subscale (affective items)] will be compared to standardised, reliable and valid reference tests [Previous diagnostic status (depression / anxiety)] to determine the accuracy of index tests in identifying impairment in the affect regulation domain of neurodevelopment.
Timepoint [15] 407969 0
Assessments will be collected within 6 months of recruitment. The time between the first and last test within the assessment battery will not exceed 6 months.

Eligibility
Key inclusion criteria
Inclusion criteria will be English-speaking children with suspected prenatal alcohol exposure, between 6- to 16-years-old. Because children with suspected prenatal alcohol exposure are heterogeneous, FASD along with other comorbid diagnoses are possible outcomes of the assessment, so additional DSM-V neurodevelopmental diagnoses are expected and will not be exclusionary.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sites currently conduct between one to four FASD or neurodevelopmental assessments per month as part of usual care. Based on assessments completed in the past year, over the 3 year data collection period, a total recruitment sample of 288 children will be available. Allowing for a 30% drop-out, a final sample of 200 participantswill be possible. The final sample will aim to have 50% representation from rural and remote sites, and 50% representation of First Nations children.

The probability of FASD diagnosis in this sample will be moderate (estimated at 50-60% by our partners) because children are referred to the services for an assessment due to significant developmental delays and suspected prenatal alcohol exposure. Two hundred participants provide a large enough sample for precise estimates of sensitivity and specificity. For example, assuming 55% of the sample have FASD, we will be able to detect a difference of 7.5% from an expected sensitivity of 80%, and a difference of 6% from an expected specificity of 90%.

Standard statistical methods for estimating diagnostic accuracy will be used including: sensitivity, specificity, positive and negative predictive values, receiver operating curves, and likelihood ratios.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
40
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 310968 0
Government body
Name [1] 310968 0
National Health and Medical Research Council (NHMRC)
Country [1] 310968 0
Australia
Funding source category [2] 310986 0
Government body
Name [2] 310986 0
Aboriginal and Torres Strait Islander Health Division, Queensland Health
Country [2] 310986 0
Australia
Funding source category [3] 310987 0
Government body
Name [3] 310987 0
Health Workforce Queensland
Country [3] 310987 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 312297 0
None
Name [1] 312297 0
Address [1] 312297 0
Country [1] 312297 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310526 0
Children's Health QLD Hospital and Health Service HREC
Ethics committee address [1] 310526 0
Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 310526 0
Australia
Date submitted for ethics approval [1] 310526 0
20/05/2020
Approval date [1] 310526 0
15/09/2020
Ethics approval number [1] 310526 0
HREC/20/QCHQ/63173
Ethics committee name [2] 310549 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 310549 0
Griffith University, Gold Coast Campus, Parklands Drive, Southport Queensland, 4222
Ethics committee country [2] 310549 0
Australia
Date submitted for ethics approval [2] 310549 0
22/09/2020
Approval date [2] 310549 0
25/09/2020
Ethics approval number [2] 310549 0
2020/743

Summary
Brief summary
Fetal Alcohol Spectrum Disorder (FASD) is a chronic disability with costly impact on families, as well as educational, health, and justice services. The prevalence of FASD ranges from 1-10%, and is as high as 19% in some remote areas. However, many affected children go undetected. Better early detection systems are needed to deliver interventions that can effectively support structural and functional brain development. Current diagnostic practices involve a lengthy assessment process that extends to multiple days per child and requires specialist expertise. Capacity to identify FASD is restricted because specialist teams are expensive, have 2-year waitlists, and exist only in urban areas. Innovative, flexible solutions are needed to ensure that children in remote Indigenous communities have access to early diagnostic services. Through extensive pilot work and strong partnerships with remote Indigenous communities, our team has co-created an innovative, culturally sensitive, tiered neurodevelopmental assessment that can be conducted in routine primary care. The current project will compare the accuracy of a rapid, tiered assessment protocol to a comprehensive assessment protocol used in Queensland specialist FASD clinics. The cost effectiveness of the tiered assessment will be assessed to further extend translation. The outcome will be (i) an expedient, validated FASD screening and assessment protocol, (ii) a culturally-sensitive protocol that has widespread applicability to remote Indigenous communities, and (iii) reduced costs and economic net benefits for families and health services.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117962 0
A/Prof Dianne Shanley
Address 117962 0
G40, Level 7, Room 7.89
School of Applied Psychology
Griffith University Gold Coast campus
1 Parklands Drive
Southport QLD 4215
Country 117962 0
Australia
Phone 117962 0
+61 7 5678 8132
Fax 117962 0
Email 117962 0
[email protected]
Contact person for public queries
Name 117963 0
Dr Wei Liu
Address 117963 0
G40, Level 7, Room 7.50
Menzies Health Institute of Queensland
Griffith University Gold Coast Campus
1 Parklands Drive
Southport QLD 4215
Country 117963 0
Australia
Phone 117963 0
+61 7 5678 0367
Fax 117963 0
Email 117963 0
[email protected]
Contact person for scientific queries
Name 117964 0
A/Prof Dianne Shanley
Address 117964 0
G40, Level 7, Room 7.89
School of Applied Psychology
Griffith University Gold Coast campus
1 Parklands Drive
Southport QLD 4215
Country 117964 0
Australia
Phone 117964 0
+61 7 5678 8132
Fax 117964 0
Email 117964 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
Data will involve sensitive health information for children, and will involve sensitive health information about Aboriginal and Torres Strait Islander children.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15377Study protocol  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDiagnostic Accuracy and economic value of a Tiered Assessment for Fetal Alcohol Spectrum Disorder (DATAforFASD): Protocol.2023https://dx.doi.org/10.1136/bmjopen-2022-071004
N.B. These documents automatically identified may not have been verified by the study sponsor.