跳至主要内容
临床试验/NCT06345170
NCT06345170已完成不适用

Investigation the Effect of the Social-Communication Area Developmental Screening Test for Infants and Young Children Training Program Applied in Addition to the DIR/Floortime™ Therapy Program in Children with Developmental Risk

Biruni University2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2022年10月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)

研究概览

简要总结

The term "developmental risk" is used as a general term for developmental delays observed in infancy and early childhood. Developmental delay refers to the delay in children reaching developmental milestones compared to their peers. The DIR/Floortime™ therapy program is an approach that uses play as a therapeutic tool, emphasising the importance of interaction involving affect and excitement in a child's development. DIR/Floortime™ therapy program aims to support the child's development with a family-centred perspective by evaluating the child and the family together. DIR/Floortime™ therapy program is known to contribute to the functional and emotional development of children and the development of parenting skills of caregivers. The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI) is a parent-reported developmental screening test that aims to identify 'delays' in the social communication area skills of infants and children. The SCASI training program is a training program for children and parents developed on the basis of this screening test, which includes targeted activities to support the development process according to the child's developmental level. To the best of our knowledge, there is no study investigating the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. The aim of the study is to examine the effect of the SCASI training program applied in addition to the DIR/Floortime™ therapy program in children with risky development. A total of 34 children with developmental risk between the ages of 1 and 3 will included in the study. Participants will randomly divided into two groups: control group (n=17) in which the DIR/Floortime™ therapy program will be applied and intervention group (n=17) in which the SCASI training program will be applied in addition to the DIR/Floortime™ therapy program. The DIR/Floortime™ therapy program will be applied by the therapist in the clinic for 50 minutes, 2 days a week for 12 weeks, and the SCASI training program will be applied by the parents at home, 2 days a week, for an average of 30 minutes a day, for 12 weeks. Demographic and clinic informations, SCASI test, Age and Stages Questionnarie (ASQ), Age and Stages Questionnaires: Social-Emotional (ASQ-SE) and Brief Infant and Toddler Social Emotional Assessment (BITSEA) will be used as outcome measures in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The child is between 1-3 years old
  • The language of the parents and the child is Turkish
  • Assessment of SİATT pre-test result as "developmental risk"
  • Parents' willingness to participate in the study

排除标准

  • xclusion Criteria:
  • Any cognitive impairment in the parents that may interfere with communication
  • Illiteracy of parents
  • The child has orthopedic, neurological disability(s) other than developmental risk

结局指标

主要结局

The Social-Communication Area Developmental Screening Test for Infants and Young Children (SCASI)

时间窗: 12 weeks

Age and Stages Questionnaires: Social-Emotional (ASQ-SE)

时间窗: 12 weeks

Brief Infant and Toddler Social Emotional Assessment (BITSEA)

时间窗: 12 weeks

Age and Stages Questionnarie (ASQ)

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hikmet Ucgun

Assistant Professor

Biruni University

研究点 (2)

Loading locations...

相似试验