Investigation of the Effectiveness of Family Collaborative Early Intervention Approach Based on Sensory Strategies, Activity Based Motor Training and Environmental Enrichment in Premature Infants: SAFE National Early Intervention Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
研究概览
简要总结
In this study, it was aimed to develop the SAFE treatment approach, which is a family collaborative early intervention approach based on sensory strategies, activity-based motor training and environmental enrichment, and to examine the effects of this approach on sensory, motor, cognitive and language development in premature infants.
详细描述
Early intervention practices in Turkey is widely based on the principle of neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach has minimal effect on the development of risky premature infants. For these reasons, it was necessary to develop an early intervention program that does not include passive interventions and includes sensory and motor strategies in our country.
Within the scope of this study, a new early intervention approach that can be applied to infants between 0-24 months has been developed based on the shortcomings in the literature. Sensory strategies, activity-based motor training, family collaboration and environmental enrichment constitute the basic principles of this early intervention program. The name of the early intervention program was formed from the English initials of these basic principles and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).
In this study, it was planned to establish the theoretical and practical foundations of the SAFE early intervention approach developed by the Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the effects of this approach on sensory, motor, cognitive and language development in preterm infants with corrected ages of 9-10 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being born before 37 weeks
- •A history of Neonatal Intensive Care Unit (NICU) for 15 days or more
- •Adjusted age to be between 9-10 months
- •Family's willingness to participate in the study
排除标准
- •Having a congenital anomaly or systemic disease
- •Having a high risk for the diagnosis of Cerebral Palsy (Intraventriculer hemorrhage (IVH) Stage 4 or periventricular leukomalacia (PVL) Stage 3-4, such as the absence of fidgety movements).
结局指标
主要结局
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
时间窗: 10 weeks
Bayley-III is a widely used test battery to assess cognitive, receptive and expressive language, gross and fine motor development in children aged 1 to 42 months. The items in each section are scored as 1 (can do the desired skill) and 0 (cannot do the desired skill). The raw scores obtained from all items are converted into scale points ranging from 1 to 19 points. Then, a composite score is obtained according to this scale score. It is the composite score commonly used in studies. Composite scores range from 40 to 160. The higher the score, the better the improvement.
次要结局
- Hammersmith Infant Neurological Examination (HINE)(10 weeks)
- The Test of Sensory Functions in Infants (TSFI)(10 weeks)
- Canadian Occupational Performance Measure (COPM)(10 weeks)
- Affordances in the Home Environment for Motor Development - Infant Scale (AHEMD-IS)(10 weeks)
- The Depression, Anxiety and Stress Scales-Short Form (DASS-21)(10 weeks)
研究者
Umut Apaydin
Research assistant, PhD, PT.
Gazi University