Yildiz Ayse, Yildiz Ramazan, Apaydin Umut, Efkere Pelin Atalan, Gücüyener Kivilcim, Hirfanoglu Ibrahim Murat, Elbasan Bulent
Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Erzurum Technical University, Erzurum, Turkey.
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Karadeniz Technical University, Trabzon, Turkey.
Child Care Health Dev. 2025 Jul;51(4):e70107. doi: 10.1111/cch.70107.
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.
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.
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).
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.
NCT06361134.
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、家庭协作和环境丰富化）对出生后前3个月婴儿的运动、认知、语言发展及感觉处理技能的影响。
26名矫正年龄为42周的婴儿纳入本研究，这些婴儿被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。本研究纳入的所有婴儿在干预前的矫正42周和干预后的矫正12周由对治疗不知情的评估者进行评估。采用贝利婴幼儿发展量表第三版（Bayley-III）评估认知和运动发展；采用婴儿运动表现测试（TIMP）评估神经运动发展；采用婴幼儿感觉概况2（ITSP 2）评估感觉处理。采用婴幼儿家庭环境量表评估家庭环境。
交互效应（时间×组）显示SAFE早期干预组具有显著优势，贝利-III运动综合得分、TIMP诱发得分和家庭环境总分更高，证明了这一点（p<0.05）。然而，交互效应（时间×组）显示两组在贝利-III认知和语言综合得分以及TIMP观察得分和TIMP总分方面没有差异（p>0.05）。时间的主效应在所有参数中均显著（p<0.05）。同样，除贝利-III语言综合得分和TIMP观察得分外，组的主要影响在所有评估参数中均显著（p<0.05）。交互效应（时间×组）表明，SAFE早期干预组在ITSP 2的总体处理得分、听觉处理得分、触觉处理得分和总分方面存在显著差异（p<0.05）。
SAFE早期干预方法比基于神经发育治疗的家庭方案能改善运动和感觉结果，并提供更丰富的家庭环境。得出结论，在高危婴儿早期采用SAFE早期干预方法可实现神经发育改善。
NCT06361134。
