Annunziata Silvia, Purpura Giulia, Piazza Elena, Meriggi Paolo, Fassina Gabriele, Santos Laura, Ambrosini Emilia, Marchetti Antonella, Manzi Federico, Massaro Davide, Tacci Andrea Luna, Bolognesi Elisabetta, Agostini Simone, La Rosa Francesca, Pedrocchi Alessandra Paola Giulia, Molina Paola, Cavallini Anna
IRCCS Fondazione Don Carlo Gnocchi, Milano, Italy.
School of Medicine and Surgery, University of Milano Bicocca, Monza, Italy.
Front Pediatr. 2025 Jan 6;12:1467783. doi: 10.3389/fped.2024.1467783. eCollection 2024.
It has been widely demonstrated that siblings of children with autism spectrum disorder (ASD) have an increased risk of abnormal developmental trajectories. In response to this, early recognition protocols have been developed worldwide, aiming to promote early interventions that can positively impact the neurodevelopment of this population. This paper presents the protocol of a controlled trial: ERI-SIBS (Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders) is an innovative and ecological early recognition and intervention program designed specifically for siblings of children with ASD.
We aim to recruit siblings at low risk and high risk of neurodevelopmental disorders. Based on clinical evaluation at T0, we will allocate the infants into three groups: Group 1, infants at low risk without any signs of neurodevelopmental disorders; Group 2, infants at high risk without any signs of neurodevelopmental disorders; Group 3: infants at low or high risk with signs suggestive of neurodevelopmental disorders. Children of Group 2 will undergo Active Monitoring (one 90 min session once a month for 6 months), while children of Group 3 will undergo Early Intervention (one 90 min session once a week for 6 months). In both cases, the ERI-SIBS contents are based on a multidimensional and naturalistic approach and always involve caregivers. All recruited children will be evaluated at three different time points (T0 within the 8 months of life of the child, T1 after 6 months and T2 after 12 months) using behavioural, technological, and biological techniques to assess infants' neurodevelopmental functions, parent-infant interaction, and early ASD markers.
The ERI-SIBS study will expand knowledge regarding the impact of early intervention on families of infants at risk of neurodevelopmental disorders for the presence of a child with a diagnosis of ASD. The study will have the potential to significantly contribute to future research and the scientific and clinical debate on the best way to implement early intervention in at-risk populations.
Clinicaltrials.gov identifier (NCT06512649).
大量研究表明，自闭症谱系障碍（ASD）患儿的兄弟姐妹出现异常发育轨迹的风险增加。对此，全球范围内已制定了早期识别方案，旨在推动早期干预，以对这一人群的神经发育产生积极影响。本文介绍了一项对照试验的方案：ERI-SIBS（神经发育障碍高危兄弟姐妹的早期识别与干预）是一项专门为ASD患儿的兄弟姐妹设计的创新型生态早期识别与干预项目。
我们旨在招募神经发育障碍低风险和高风险的兄弟姐妹。根据T0时的临床评估，我们将婴儿分为三组：第1组，无任何神经发育障碍迹象的低风险婴儿；第2组，无任何神经发育障碍迹象的高风险婴儿；第3组：有神经发育障碍迹象的低风险或高风险婴儿。第2组的儿童将接受主动监测（每月一次，每次90分钟，共6个月），而第3组的儿童将接受早期干预（每周一次，每次90分钟，共6个月）。在这两种情况下，ERI-SIBS的内容均基于多维度和自然主义的方法，并且始终涉及照顾者。所有招募的儿童将在三个不同的时间点（儿童出生8个月内的T0、6个月后的T1和12个月后的T2）接受评估，使用行为、技术和生物学技术来评估婴儿的神经发育功能、亲子互动和早期ASD标志物。
ERI-SIBS研究将扩展关于早期干预对因家中有一名被诊断为ASD的儿童而面临神经发育障碍风险的婴儿家庭的影响的知识。该研究有可能对未来的研究以及关于在高危人群中实施早期干预的最佳方式的科学和临床辩论做出重大贡献。
Clinicaltrials.gov标识符（NCT06512649）。
