Early detection of Australian Aboriginal and Torres Strait Islander infants at high risk of adverse neurodevelopmental outcomes at 12 months corrected age: LEAP-CP prospective cohort study protocol

Abstract

IntroductionNeurodevelopmental disorders (NDD), including cerebral palsy (CP), autism spectrum disorder (ASD) and foetal alcohol spectrum disorder (FASD), are characterised by impaired development of the early central nervous system, impacting cognitive and/or physical function. Early detection of NDD enables infants to be fast-tracked to early intervention services, optimising outcomes. Aboriginal and Torres Strait Islander infants may experience early life factors increasing their risk of neurodevelopmental vulnerability, which persist into later childhood, further compounding the health inequities experienced by First Nations peoples in Australia. The LEAP-CP prospective cohort study will investigate the efficacy of early screening programmes, implemented in Queensland, Australia to earlier identify Aboriginal and Torres Strait Islander infants who are ‘at risk’ of adverse neurodevelopmental outcomes (NDO) or NDD. Diagnostic accuracy and feasibility of early detection tools for identifying infants ‘at risk’ of a later diagnosis of adverse NDO or NDD will be determined.Methods and analysisAboriginal and/or Torres Strait Islander infants born in Queensland, Australia (birth years 2020–2022) will be invited to participate. Infants aged <9 months corrected age (CA) will undergo screening using the (1) General Movements Assessment (GMA); (2) Hammersmith Infant Neurological Examination (HINE); (3) Rapid Neurodevelopmental Assessment (RNDA) and (4) Ages and Stages Questionnaire-Aboriginal adaptation (ASQ-TRAK). Developmental outcomes at 12 months CA will be determined for: (1) neurological (HINE); (2) motor (Peabody Developmental Motor Scales 2); (3) cognitive and communication (Bayley Scales of Infant Development III); (4) functional capabilities (Paediatric Evaluation of Disability Inventory-Computer Adaptive Test) and (5) behaviour (Infant Toddler Social and Emotional Assessment). Infants will be classified as typically developing or ‘at risk’ of an adverse NDO and/or specific NDD based on symptomology using developmental and diagnostic outcomes for (1) CP (2) ASD and (3) FASD. The effects of perinatal, social and environmental factors, caregiver mental health and clinical neuroimaging on NDOs will be investigated.Ethics and disseminationEthics approval has been granted by appropriate Queensland ethics committees; Far North Queensland Health Research Ethics Committee (HREC/2019/QCH/50533 (Sep ver 2)-1370), the Townsville HHS Human Research Ethics Committee (HREC/QTHS/56008), the University of Queensland Medical Research Ethics Committee (2020000185/HREC/2019/QCH/50533) and the Children’s Health Queensland HHS Human Research Ethics Committee (HREC/20/QCHQ/63906) with governance and support from local First Nations communities. Findings from this study will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberACTRN12619000969167.

Study protocol: peer delivered early intervention (Learning through Everyday Activities with Parents for Infants at risk of Cerebral Palsy: LEAP-CP) for First Nation Australian infants at high risk of cerebral palsy – an RCT study

“…The overarching study consists of two component studies: (1) Early intervention study, testing the effectiveness of a novel peer-delivered multidomain intervention (LEAP-CP) a randomised assessor masked controlled multisite trial; and (2) Detection study, exploring the validity of an early detection programme for identifying First Nations Australian infants at high risk of CP and/or neurodevelopmental disability (NDD) 17. The intervention study, informed by the Consolidated Standards of Reporting Trials guidelines, will be described in detail in this protocol (see figure 1).…”

“…Questions include infant preterm status, birth complications, presence of seizures and use of medications. Questions will also assess maternal risk factors including socioeconomic risks (contributing with the perinatal data to scoring of the Social Risk Index 66 on a 12-point scale) and maternal alcohol use via the Alcohol Use Disorders Identification Test ( AUDIT-C ) questionnaire 17 67…”

“…Perinatal data (T0): The following data will be collected from the infant’s medical records (for full detail see Luke, et al 17);…”

“…In order to determine a diagnosis of CP or another NDD (autism spectrum disorder (ASD), fetal alcohol spectrum disorder (FASD) or developmental delay) (confirmed or suspected) the Medical Assessment for Differential Diagnosis 17 will be completed by a qualified paediatrician according to published guidelines, (1) blinded; and (2) based on clinical history (on the Medical Checklist), brain imaging as available, and videoed HINE and Gross Motor Function Classification System semi-structured play session at 24 months C.A. Differential diagnosis will be based on the following guidelines:…”

“…Assessments will be conducted by a trained practitioner/researcher (medical/allied health/community health worker) in conjunction with an Aboriginal Health Worker/liaison officer at baseline (T0), post-intervention (T1) and at 2 years CA (T2). If any of the assessment points are within 1 month of another assessment point (including those in the LEAP-CP detection study 17 ), the two assessments will be combined. All questionnaires will be translated into Aboriginal English (as approved by test authors) and introduced using a culturally-adapted script.…”