Early intervention program by ICF model for babies of 4-18 months frequenting daycare center: protocol for clinical trial

Abstract Introduction: A daycare center is a long-term place for infants, which means that early intervention programs should be thought of in this environment. There are still many gaps regarding the best way of stimulation/intervention, duration and description of effects and controlled outcomes. Aim: The objective of this clinical trial is to propose an early physical activity intervention program performed in infants of 4-18 months with risk/delay and with typical development at infant’s daycare. Method: The protocol of this study is indicated for a controlled trial, in a crossover format, to be applied in 4 groups composed by in 4-18 month-old infants who attend daycare: Intervention group 1 Typical, Intervention group 1 Risk/delay, group Intervention 2 Typical, group Intervention 2 Risk/delay, in 4-18 month old infants who attend daycare. The ICF criteria about functions and structure (through evaluation questionnaire) are considered, as well as activities and participation (AIMS, Denver II, and PedsQl™ evaluation), personal characteristics (questionnaire, ABEP and AHEMD-IS) and environmental factors (AHEMD-IS). Conclusion: This original proposal can highlight a low-cost intervention program performed in a daycare environment verifying the infant's NMD in a systematized way using theoretical basis.

摘要 引言：日托中心是婴幼儿长期照护的核心场所，这意味着理应在此类场景中开展早期干预方案。但目前在最优刺激/干预方案制定、干预时长把控、效应与对照结局的规范描述等方面仍存在诸多研究空白。
研究目的：本临床试验旨在为日托中心内的4~18月龄婴幼儿（涵盖存在发育风险/迟缓者与典型发育者）提出一套标准化早期体能活动干预方案。
研究方法：本研究采用交叉设计的对照试验方案，受试对象为入托的4~18月龄婴幼儿，共分为4组：典型发育干预组1、发育风险/迟缓干预组1、典型发育干预组2、发育风险/迟缓干预组2。本研究纳入基于ICF（国际功能、残疾和健康分类，International Classification of Functioning, Disability and Health）的功能与结构标准（通过评估问卷采集数据），同时覆盖活动与参与维度（采用AIMS、Denver II及PedsQl™评估工具）、个体特征（通过问卷、ABEP与AHEMD-IS采集）以及环境因素（通过AHEMD-IS采集）。
研究结论：本原创方案可凸显一种在日托中心环境中开展的低成本干预方案，能够依托理论基础以系统化方式对婴幼儿的NMD进行评估验证。