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临床试验/NCT02988180
NCT02988180已完成不适用

Developmental and Growth Status of Children (6-60 Months of Age) in Extreme Poverty in Jimma Town of Ethiopia: Effects of Developmental Stimulation - RAI (Risk Analysis and Intervention)

Hasselt University2 个研究点 分布在 2 个国家目标入组 78 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
fine motor outcome

研究概览

简要总结

Children in extreme poverty lack adequate care and face increased health risks. The earlier poverty strikes in the developmental process, the more deleterious and long-lasting its effects. There is, however, growing evidence that early interventions can prevent the negative consequences. Such interventions are effective, particularly when they are of high quality, organized at home and parents are involved. Recently, baseline assessment of developmental and nutritional status of SOS children and children in extreme poverty in Jimma region of South-West Ethiopia revealed that these children have developmental problems in language, motor, social-emotional skills and nutritional status. The impact of play-oriented stimulation activities integrated into the existing SOS basic program, on developmental outcomes, has never been investigated in this context. The main objective of the study is, therefore, to evaluate the impact of play-oriented stimulation integrated into the basic SOS program on the developmental outcomes of children living with foster families. This was done by comparing the intervention children with their age-matched children (control), not receiving the stimulation package. It was hypothesized that this package would significantly improve the developmental skills of these children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

年龄范围
3 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children who were selected by the SOS children's village as lacking parental care and receive basic services;
  • Children living in Jimma town;
  • Children from 3 months to 59 months of age.

排除标准

  • Children with observable physical disabilities which hinders mobility;
  • Children with severe mental retardation;
  • Children with discernable hearing and visual impairments.

结局指标

主要结局

fine motor outcome

时间窗: 6 months

Denver II-Jimma was used to test fine motor outcome and performance ratio was calculated for analysis

language outcoome

时间窗: 6 months

Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis

Personal-social outcome

时间窗: month 6

Denver II-Jimma was used to test personal-social outcome and performance ratio was calculated for analysis

gross motor outcome

时间窗: 6 months

Denver II-Jimma was used to test gross motor outcome and performance ratio was calculated for analysis

Social-emotional outcome

时间窗: 6 months

Ages and Stages Questionnaires: Social Emotional (ASQ: SE) was used to measure social-emotional development of the children

language outcome

时间窗: 3 months

Denver II-Jimma was used to test language outcome and performance ratio was calculated for analysis

次要结局

  • weight(6 months)
  • Height(6 months)

研究者

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

prof. dr. Marita Granitzer

prof.dr.

Hasselt University

研究点 (2)

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