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临床试验/NCT03764436
NCT03764436已完成不适用

Youth Leaders for Early Childhood Assuring Children Are Prepared for School - National Commission for Human Development (LEAPS-NCHD) Program Evaluation

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 3,858 人开始时间: 2019年1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
3,858
试验地点
1
主要终点
School readiness

研究概览

简要总结

An estimated 88 million children drop out of primary school each year worldwide, and the highest number of dropouts are in the first and second grade. A proven strategy to reduce dropout from primary school is participation in early childhood care and education (ECCE) services that bolster young children's health, development and readiness for school. Access to quality ECCE services remains highly limited in Pakistan: less than 50% of four-year-olds are estimated to attend ECCE services, and skilled ECCE workers remain scarce.

To address these challenges, LEAPS (Youth Leaders for Early Childhood Assuring Children are Prepared for School) was developed as a cross-generational strategy to support the learning and development of young children (3.5- to 5.5-year-olds) and female youth (18- to 24-year-olds). The program provides vocational training to female youth, referred to as Community Youth Leaders (CYLs), to deliver a community-based preschool program in rural Sindh, Pakistan. The LEAPS program was previously developed in partnership with Pakistan's National Commission for Human Development (NCHD), a government entity charged with supporting community health, education, and vocational training programs. Efficacy and feasibility of the LEAPS strategy were demonstrated through a prior pilot evaluated in a cluster-randomized controlled trial in 2015 (NCT02645162).

The NCHD is now seeking to integrate the LEAPS program within their full suite of services and to scale the program across 99 villages in rural Sindh under the technical guidance and support of a local implementation support team led by the Aga Khan University. This intervention utilizes two strategies: i) the first is the implementation of the LEAPS program, led by NCHD; and ii) the second is the technical support of the NCHD, to ensure the system is able to support program expansion and sustainability.

This study uses a cluster-randomized stepped-wedge design with three steps to assess program impact on school readiness and child and youth development outcomes across the 99 villages ("clusters"). All clusters will begin in the control state (i.e. access to standard community services). Prior to the start of the trial, clusters will be randomized to 'cross-over' to the intervention state (i.e. introduction of the LEAPS-NCHD program) during one of three sequential steps. Each step will be approximately 9-11 months. By the end of the trial, all clusters will have been exposed to the intervention. Measurement is assessed across all clusters at each step. The total duration of the trial will be 31 months. A process evaluation will also be conducted to examine the large-scale implementation of the LEAPS-NCHD Program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
54 Months 至 66 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Resides in the targeted villages
  • Aged 54 - 66 months
  • Child's primary caregiver must provide both i) informed consent for the caregiver's own participation in the study and ii) permission for the child's participation in the study.
  • Child must provide assent for participation in the study.

排除标准

  • Child shows signs of severe clinical health condition or disability.

结局指标

主要结局

School readiness

时间窗: Up to 31 months

School readiness of children aged 54 - 66 months assessed using the International Development \& Early Learning Assessment (IDELA). IDELA includes domains for emergent math (7 items), socio-emotional development (5 items), self-regulation (1 item), emergent literacy (6 items), fine motor skills (3 items), and gross motor skills (1 item). Total scores are calculated for each domain, and a total IDELA score for school readiness is generated from the domain scores. Higher scores reflect better outcomes.

次要结局

  • Child general executive functioning skills(Up to 31 months)
  • Child executive functioning skills: working memory(Up to 31 months)
  • Child executive functioning skills: cognitive flexibility(Up to 31 months)
  • Classroom structural and process quality(Assessed after program has been running for a minimum of 2 months)
  • Youth executive functioning skills: inhibitory control(Up to 31 months)
  • Youth personal and professional development(Up to 31 months)
  • Youth executive functioning skills: cognitive flexibility(Up to 31 months)
  • Youth self-reported depressive symptoms(Up to 31 months)
  • Child executive functioning skills: inhibitory control(Up to 31 months)
  • Youth executive functioning skills: working memory(Up to 31 months)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aisha K Yousafzai

Associate Professor of Global Health

Harvard School of Public Health (HSPH)

研究点 (1)

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