Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
BMJ Open. 2023 Mar 13;13(3):e059531. doi: 10.1136/bmjopen-2021-059531.
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).
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.
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 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.
ACTRN12619000969167p.
脑瘫（CP）是最常见的儿童身体残疾，在澳大利亚原住民儿童中的发病率约高 50%。本研究旨在评估一种针对有脑瘫高风险的澳大利亚原住民婴儿的文化适应型父母主导的早期干预方案（通过日常活动与父母一起学习以促进脑瘫患儿发展；LEAP-CP）。
这是一项随机评估员盲法对照试验。有出生/产后危险因素的婴儿将有资格进行筛查。有脑瘫高风险的婴儿（GMs 评估中“缺乏烦躁不安”，或 Hammersmith 婴儿神经检查中“得分不佳”），校正年龄 12-52 周，将被招募。婴儿及其照顾者将被随机分配接受 LEAP-CP（干预）或健康咨询（对照）。LEAP-CP 是一项由同伴培训师（原住民社区卫生工作者）提供的 30 次家访的文化适应方案；包括有针对性的主动运动/认知策略、脑瘫学习游戏和照顾者教育模块。对照组每月接受一次基于关键家庭实践的健康咨询，来自世卫组织。所有婴儿继续接受标准（主流）常规护理。双重儿童主要结局是 Peabody 发育运动量表-2（PDMS-2）和贝利婴幼儿发育量表-III。主要照顾者结局是抑郁、焦虑和压力量表。次要结局包括功能、目标实现、视力、营养状况和情感可及性。
总共 86 名儿童（每组 43 名）将能够检测到 PDMS-2 上 0.65 的效应量（80%的效力，α=0.05；10%的失访率）。
昆士兰州伦理委员会和原住民控制社区卫生组织研究治理小组的伦理批准，并获得家庭的书面知情同意。研究结果将在参与式行动研究的指导下传播，与原住民社区合作；同行评议期刊出版物和国家/国际会议演讲。
ACTRN12619000969167p。
