BMJ Open · 17 authors, 13 centres
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This protocol describes a randomized controlled trial testing a culturally adapted, peer-delivered early intervention (LEAP-CP) for First Nations Australian infants at high risk of cerebral palsy. The intervention, delivered by First Nations Community Health Workers, aims to improve motor and cognitive development compared to standard health advice. If effective, this model could reduce disparities in early intervention access and outcomes for this high-risk population.
**Background:** Cerebral palsy (CP) is the most common childhood physical disability, with rates approximately 50% higher in First Nations Australian children (4.01/1000 vs 2.72/1000 in 1996–2005). First Nations communities face increased exposure to infant risk factors for CP due to sociocultural determinants, yet often do not receive diagnosis or intervention until after the child's second birthday, missing a critical window for neuroplasticity. The Learning through Everyday Activities with Parents for infants at risk of Cerebral Palsy (LEAP-CP) programme aims to address this gap by providing a culturally adapted, peer-delivered early intervention for First Nations Australian infants at high risk of CP.
**Methods:** This is a randomized assessor-masked controlled multisite trial. Infants (aged 12–52 weeks corrected age) with one or both parents identifying as Aboriginal and/or Torres Strait Islander, who are at high risk of CP (determined by absent fidgety on General Movements Assessment and/or suboptimal Hammersmith Infant Neurological Examination score) will be recruited. Exclusion criteria include known chromosomal/neurodegenerative conditions or complex medical conditions requiring acute care. After baseline assessments, families will be block randomized (1:1 ratio, stratified by neurological severity) to receive either LEAP-CP plus care as usual or health advice plus care as usual. LEAP-CP consists of 30 weekly home visits (60 minutes each) delivered by a First Nations Community Health Worker (FNCHW), including goal-directed active motor/cognitive training, CP learning games, and caregiver educational modules. The control arm receives 7 monthly health advice visits based on WHO Key Family Practices. All infants continue standard care as usual. Dual primary child outcomes are the Peabody Developmental Motor Scales-2 (PDMS-2) and Bayley Scales of Infant Development-III (BSID-III). The primary caregiver outcome is the Depression, Anxiety and Stress Scale (DASS). Secondary outcomes include function (PEDI-CAT), goal attainment (COPM, ATOMIC), vision (PreViAS), nutritional status, emotional availability (EAS), and home environment (HOME). Sample size: 86 children (43 per group) will enable detection of an effect size of 0.65 on PDMS-2 (80% power, α=0.05, 10% attrition). Recruitment commenced July 2021; to date, 143 infants have been screened, with 8 recruited.
**Key Results:** This is a study protocol; no results are reported. The paper describes the rationale, design, interventions, outcome measures, and analysis plan in detail.
**Clinical Implications:** If effective, LEAP-CP could provide a scalable, culturally appropriate model for early detection and intervention for First Nations Australian infants at high risk of CP. By leveraging peer delivery through FNCHWs and telehealth support from allied health professionals, the programme aims to overcome barriers to access and improve developmental outcomes while supporting caregiver mental health and family functioning. The study is expected to inform policy and practice for early intervention in this underserved population.