RecruitingACTRN12622000498796

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


Sponsor

Griffith University

Enrollment

200 participants

Start Date

Apr 11, 2022

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 6 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Fetal Alcohol Spectrum Disorder, or FASD, is a lifelong condition caused by alcohol exposure before birth. It affects how the brain develops and can lead to difficulties with learning, behaviour, memory, and daily life. FASD affects at least one in a hundred people, and in some remote communities the rate is much higher. Despite this, many children go undiagnosed for years because the current assessment process is lengthy and requires expensive specialist teams located mainly in cities. This study is testing a faster, more flexible way to assess children for FASD. A culturally sensitive, tiered approach developed in partnership with remote Indigenous communities will be compared to the full specialist clinic assessment used in Queensland. The tiered method is designed to be carried out in everyday primary care settings, making diagnosis more accessible to families everywhere. Your child may be eligible if they are between 6 and 16 years old, speak English, and are suspected to have had prenatal alcohol exposure. There are no other exclusion criteria — all children with suspected exposure are welcome regardless of other diagnoses they may have.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, aff

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.


Locations(1)

NT,QLD,VIC, Australia

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ACTRN12622000498796