Silvia Annunziata, Giulia Purpura, Elena Piazza, Paolo Meriggi, Gabriele Fassina, Laura Santos, Emilia Ambrosini, Antonella Marchetti, Federico Manzi, Davide Massaro, Andrea Luna Tacci, Elisabetta Bolognesi, Simone Agostini, Francesca La Rosa, Alessandra Paola Giulia Pedrocchi, Paola Molina, Anna Cavallini
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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. 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引用次数: 0
摘要
背景：广泛的研究表明，自闭症谱系障碍（ASD）儿童的兄弟姐妹出现异常发育轨迹的风险增加。针对这一点，世界各地已经制定了早期识别协议，旨在促进早期干预，对这一人群的神经发育产生积极影响。ERI-SIBS （Early Recognition and Intervention in sibling at High Risk for neurodevelopmental Disorders）是一项专门为ASD患儿的兄弟姐妹设计的创新的生态早期识别和干预项目。方法：我们的目标是招募低风险和高风险神经发育障碍的兄弟姐妹。根据T0时的临床评估，我们将婴儿分为三组：第一组，无任何神经发育障碍迹象的低风险婴儿；第二组：无任何神经发育障碍迹象的高危婴儿；第三组：具有提示神经发育障碍迹象的低或高风险婴儿。第二组儿童将接受主动监测（每月一次，每次90分钟，持续6个月），第三组儿童将接受早期干预（每周一次，每次90分钟，持续6个月）。在这两种情况下，ERI-SIBS内容都基于多维和自然的方法，并且总是涉及到照顾者。所有招募的儿童将在三个不同的时间点进行评估（T0在儿童8个月内，T1在6个月后，T2在12个月后），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标记。讨论：ERI-SIBS研究将扩大早期干预对有ASD诊断的儿童存在神经发育障碍风险的婴儿家庭的影响的知识。这项研究将有可能对未来的研究以及对高危人群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。临床试验注册：Clinicaltrials.gov识别码（NCT06512649）。
Early Recognition and Intervention in SIBlingS at High Risk for Neurodevelopment Disorders (ERI-SIBS): a controlled trial of an innovative and ecological intervention for siblings of children with autism spectrum disorder.
Background: 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.
Methods: 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.
Discussion: 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.
期刊介绍：
Frontiers in Pediatrics (Impact Factor 2.33) publishes rigorously peer-reviewed research broadly across the field, from basic to clinical research that meets ongoing challenges in pediatric patient care and child health. Field Chief Editors Arjan Te Pas at Leiden University and Michael L. Moritz at the Children''s Hospital of Pittsburgh are supported by an outstanding Editorial Board of international experts. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
Frontiers in Pediatrics also features Research Topics, Frontiers special theme-focused issues managed by Guest Associate Editors, addressing important areas in pediatrics. In this fashion, Frontiers serves as an outlet to publish the broadest aspects of pediatrics in both basic and clinical research, including high-quality reviews, case reports, editorials and commentaries related to all aspects of pediatrics.
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