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.

Introduction: Cerebral 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 Analysis: This 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 Dissemination: Ethics 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 Number: ACTRN12619000969167p.