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临床试验/NCT02545491
NCT02545491已完成不适用

Implementation of Care for Child Development and Implications on Early Childhood Development: A Pilot Study in Lebanon

American University of Beirut Medical Center2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
2
主要终点
Enhancing child development. (developmental scores by BSID-III )

研究概览

简要总结

Background: Responsive stimulation and/or enhanced nutrition interventions delivered to children through health programs shows improved cognitive, language, and motor, and the social-emotional status. This could benefit young children in Lebanon and worldwide to improve their developmental potential.

Aim: This study aims to implement Care for Child Development (CCD) intervention for children aged 0-3 years within a supportive environment in Day Care Centers and to investigate its effectiveness on early child development.

Methodology: CCD program will be implemented in 10 randomly selected daycare centers in Lebanon where three providers in each center will be trained (CCD-group). Another group of 10 day care centers will serve as controls (WV-group). 228 Children in each group will receive either early stimulation based on CCD and education from the World Vision Infant and Young Child Feeding (WV-IYCF) project (CCD-group) or education from the WV-IYCF project (WV-group). Caregivers' knowledge and behaviors will be assessed before and after the intervention using a predetermined questionnaire and behavioral checklist. Early child development will be assessed using Ages and Stages Questionnaire-3 (ASQ-3) and Bayley Scale for infant Development (BSID-III).

Expected Outcome: Implementation of CCD program in day care centers will be feasible and will lead to enhanced early child development. This study will serve as a prototype for program implementation throughout the country and the region.

详细描述

This study aims at testing the implementation and effectiveness of the CCD program on early child development in selected day care centers in Beirut. It is being conducted in collaboration with World Vision and the Lebanese Ministry of Public Health.

Day Care centers are invited by the ministry of health to participate in this proposed study.

After securing the approval of the Center's director, caregivers working at those day care centers are being invited to participate in this study.

Those caregivers who agree to participate will receive either training on the CCD program AND early child nutrition from World Vision (Infant & Young Child Feeding Project WV-IYCFP) (Intervention group) or training on early child nutrition from WV-IYCFP only (control group).

The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides caregivers with recommendations for stimulating child development through play and communication activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Children aged 0 to 3 years registered in the selected daycare centers.

排除标准

  • Children diagnosed with medical conditions that might affect developmental assessment, or who are older than the specified ages will not be included in the study.

研究组 & 干预措施

Care for Child Development group

Experimental

Training of caregivers on the Care for Child Development (CCD) program, in addition to the training on Infant and Young Child feeding program by World Vision.

干预措施: Care for Child Development (CCD) program (Behavioral)

Care for Child Development group

Experimental

Training of caregivers on the Care for Child Development (CCD) program, in addition to the training on Infant and Young Child feeding program by World Vision.

干预措施: Infant and Young Child feeding training by World Vision (Behavioral)

World Vision Lebanon training group

Active Comparator

caregivers will receive training in Infant and Young Child Feeding (WV-IYCF) offered by World Vision.

干预措施: Infant and Young Child feeding training by World Vision (Behavioral)

结局指标

主要结局

Enhancing child development. (developmental scores by BSID-III )

时间窗: one year

Children in the CCD-group will have better developmental scores by BSID-III compared to those in the WV- group.

次要结局

  • Caregivers' behavior (measured by behavioral observation using predetermined checklist)(one year)
  • Caregivers' knowledge (measured by pre and post assessement test)(one year)

研究者

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

Lama Charafeddine

Assistant Professor in Clinical Pediatrics, MD FAAP

American University of Beirut Medical Center

研究点 (2)

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