Effects of SAFE Early Intervention Approach in the First Months of Life in Infants at Risk: A Randomized Controlled Study

IF 1.8 4区医学 Q2 PEDIATRICS

Child Care Health and Development Pub Date : 2025-05-28 DOI:10.1111/cch.70107

Ayse Yildiz, Ramazan Yildiz, Umut Apaydin, Pelin Atalan Efkere, Kivilcim Gücüyener, Ibrahim Murat Hirfanoglu, Bulent Elbasan

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引用次数: 0

Abstract

Background

This study aimed to examine the effects of the SAFE early intervention approach (Sensory strategies, Activity-based motor training, Family collaboration, and Environmental Enrichment), developed for at-risk infants, on motor, cognitive, language development, and sensory processing skills in the first 3 months of life.

Methods

Twenty-six infants with a corrected age of 42 weeks were included in the study, and the infants were randomly distributed to the treatment and control groups. The SAFE early intervention approach was applied to 14 infants in the treatment group, and the Neurodevelopmental Treatment-based home programme was applied to 12 infants in the control group. All infants included in the study were evaluated at the corrected 42nd week before the intervention and at the corrected 12th week after the intervention by an evaluator blinded to the treatment. Bayley Scales of Infant and Toddler Development III (Bayley-III) to evaluate cognitive and motor development; Test of Infant Motor Performance (TIMP) to evaluate neuromotor development; Infant/Toddler Sensory Profile 2 (ITSP 2) to assess sensory processing t was used. The Infant/Toddler HOME Inventory was used to evaluate the home environment.

Results

The interaction effects (time × group) revealed significant advantages for the SAFE early intervention group, evidenced by higher scores in the Bayley-III motor composite, TIMP elicited and HOME total assessments (p < 0.05). However, the interaction effects (time × group) showed no differences between the groups in the Bayley-III cognitive and language composite scores, as well as the TIMP observed and TIMP total scores (p > 0.05). The main effect for time was significant in all parameters (p < 0.05). Similarly, the main impact for groups was substantial in all evaluation parameters except the Bayley-III language composite score and TIMP observed score (p < 0.05). The interaction effects (time × group) demonstrated significant differences in favour of the SAFE early intervention group for the general processing score, auditory processing score, tactile processing score and total score of the ITSP 2 (p < 0.05).

Conclusions

The SAFE early intervention approach enhanced motor and sensory outcomes and provided a more enriched home environment than the NDT-based home programme. It was concluded that neurodevelopmental improvement will be achieved with the SAFE early intervention approach in the early period in at-risk infants.

Trial Registration: NCT06361134

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一项随机对照研究：安全早期干预方法对高危婴儿生命最初几个月的影响

本研究旨在探讨为高危婴儿开发的SAFE早期干预方法（感觉策略、基于活动的运动训练、家庭合作和环境丰富）对出生后头3个月的运动、认知、语言发展和感觉处理技能的影响。方法选取校正年龄为42周龄的婴儿26例，随机分为治疗组和对照组。治疗组的14名婴儿采用SAFE早期干预方法，对照组的12名婴儿采用基于神经发育治疗的家庭方案。所有纳入研究的婴儿在干预前的第42周和干预后的第12周由一名对治疗不知情的评估者进行评估。贝利婴幼儿发展量表III （Bayley-III）评估认知和运动发展；婴儿运动表现测试（TIMP）评价神经运动发育使用婴儿/幼儿感觉档案2 （ITSP 2）来评估感觉处理。使用婴幼儿家庭问卷来评估家庭环境。结果交互效应（时间×组）显示SAFE早期干预组显著优势，Bayley-III运动综合评分、TIMP诱导评分和HOME总评分均较高（p < 0.05）。然而，交互效应（时间×组）各组在Bayley-III认知和语言综合得分、TIMP观察得分和TIMP总分上均无差异（p > 0.05）。时间对各参数的主效应均显著（p < 0.05）。同样，除Bayley-III语言综合评分和TIMP观察评分外，各组间的主要影响均显著（p < 0.05）。交互效应（时间×组）显示，SAFE早期干预组在ITSP 2的一般加工评分、听觉加工评分、触觉加工评分和总分上均有显著差异（p < 0.05）。结论：SAFE早期干预方法提高了运动和感觉结果，并提供了比基于ndt的家庭方案更丰富的家庭环境。结论是，在高危婴儿早期采用SAFE早期干预方法可以实现神经发育的改善。试验注册：NCT06361134

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来源期刊

Child Care Health and Development 医学-小儿科

CiteScore

3.40

自引率

5.30%

发文量

136

审稿时长

4-8 weeks

期刊介绍： Child: care, health and development is an international, peer-reviewed journal which publishes papers dealing with all aspects of the health and development of children and young people. We aim to attract quantitative and qualitative research papers relevant to people from all disciplines working in child health. We welcome studies which examine the effects of social and environmental factors on health and development as well as those dealing with clinical issues, the organization of services and health policy. We particularly encourage the submission of studies related to those who are disadvantaged by physical, developmental, emotional and social problems. The journal also aims to collate important research findings and to provide a forum for discussion of global child health issues.