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临床试验/NCT06052410
NCT06052410已完成不适用

The Effect of Early Intervention on Sensory, Cognitive and Motor Outcomes in Children at Risk of Developmental Delay: A Randomized Controlled Study

Hacettepe University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Infants/Toddler Sensory Profile 2 (ITSP 2)

研究概览

简要总结

Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. For this reason, the study examined the effects of an early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, an evidence-based early intervention program, on the sensory, cognitive and motor skills of babies at risk of developmental delay for 24-36 months.

详细描述

Children with developmental delays benefit from early intervention. Therefore, it is very important to detect developmental delays as early as possible. In recent years, there has been increasing interest in designing and providing early intervention programs to improve developmental outcomes for infants at risk for developmental delay for neurodevelopmental disorders. Early intervention includes services provided to children from birth to age five to promote the child's health and well-being, develop emerging skills, minimize developmental delays, correct existing or emerging disabilities, prevent functional impairment, and promote parental compliance. When the literature is examined, it is seen that early intervention approaches are mostly implemented in preterm babies and focus on motor skills. An example of studies carried out with this attitude is Neurodevelopmental Treatment (NGT), which is frequently used in early intervention approaches in Turkey. Another early intervention approach that includes intensive motor training is Goal, Activity and Motor Enrichment (GAME). GAME early intervention approach is also used in extremely preterm babies with a high risk of developmental delay; It has been used in studies as an intervention approach that includes goal-oriented motor training, environmental enrichment and family education. Another early intervention approach that addresses parent education and environmental enrichment principles is the Supporting Play, Exploration and Early Development Intervention (SPEEDI). The SPEEDI program was applied to preterm babies in a similar way to the GAME program. Other approaches used by occupational therapists for children at risk of developmental delay in the literature are home-based and routine-based approaches.

When the literature is examined, it is seen that early intervention programs are mostly carried out with premature babies and/or for the diagnosis of cerebral palsy (CP). Early intervention approaches in the literature include intensive motor training, parent training, environmental enrichment, participation support and home visits. Although it is stated in the literature that development should be considered as a whole and sensory, cognitive and motor outcomes are interrelated, it is seen that interventions for sensory and cognitive skills are not included in early intervention studies. Therefore, the aim of our study is to improve the sensory, cognitive and motor skills of the early occupational therapy intervention program, which includes sensory, cognitive and motor strategies based on the principles of Goal, Activity and Motor Enrichment-GAME, which is an evidence-based early intervention program, in babies at risk of developmental delay of 24-36 months. to examine its effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
24 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Being at risk of developmental delay between 24 and 36 months
  • Not having received any neurological, psychiatric or orthopedic diagnosis,
  • The family is willing to participate in the study and agrees to participate regularly in the intervention program and evaluations.

排除标准

  • Babies staying in institutional care,
  • Having any neurological, psychiatric or orthopedic diagnosis

结局指标

主要结局

Infants/Toddler Sensory Profile 2 (ITSP 2)

时间窗: 10 minutes

It is a 5-point Likert type scale filled out by families that evaluates the sensory processing skills of children aged 7-35 months.

次要结局

  • Bayley Scales of Infant and Toddler Development III (Bayley III),(40 minutes)
  • Ages and Stages Questionnaire (ASQ) and Ages and Stages Questionnaire- Social Emotional (ASQ-SE).(45 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezginur Gündoğmuş

Occupational Therapist

Hacettepe University

研究点 (2)

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