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Diagnostic Accuracy and economic value of a Tiered Assessment (DATA) for Fetal Alcohol Spectrum Disorder (FASD)

Diagnostic Accuracy and economic value of a Tiered Assessment (DATA) for Fetal Alcohol Spectrum Disorder (FASD) in urban, rural, and remote Australia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000498796
Acronym
DATAforFASD
Enrollment
148
Registered
2022-03-29
Start date
2022-04-11
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 whe

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.

Sponsors

Griffith University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No

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.

Exclusion criteria

There are no exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 17, 2026