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.

IntroductionCerebral palsy (CP) is the most common childhood physical disability with rates approximately 50% higher in First Nations Australian children. This study aims to evaluate a culturally-adapted parent-delivered early intervention programme for First Nations Australian infants at high risk of CP (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP).Methods and analysisThis study is a randomised assessor masked controlled trial. Infants with birth/postnatal risk factors will be eligible for screening. Infants at high risk of CP (‘absent fidgety’ on General Movements Assessment, and/or ‘suboptimal score’ on the Hammersmith Infant Neurological Examination) aged 12–52 weeks corrected age will be recruited. Infants and their caregivers will be randomised to receive LEAP-CP (intervention) or health advice (comparator). LEAP-CP is a culturally-adapted programme of 30 home visits delivered by a peer trainer (First Nations Community Health Worker); and includes goal-directed active motor/cognitive strategies, CP learning games and caregiver educational modules. The control arm receives a monthly health advice visit, based on the Key Family Practices, WHO. All infants continue to receive standard (mainstream) Care as Usual. Dual child primary outcomes are Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III. The primary caregiver outcome is the Depression, Anxiety and Stress Scale. Secondary outcomes include function, goal attainment, vision, nutritional status and emotional availability. Sample size: total of 86 children (43/group) will enable an effect size of 0.65 on the PDMS-2 to be detected (80% power, α=0.05; 10% attrition).Ethics and disseminationEthics approval through Queensland ethics committees and Aboriginal Controlled Community Health Organisation Research Governance Groups, with families providing written informed consent. Findings will be disseminated with guidance from the Participatory Action Research, in collaboration with First Nations communities; peer-reviewed journal publications and national/international conference presentations.Trial registration numberACTRN12619000969167p.