跳至主要内容
临床试验/NCT05197985
NCT05197985终止不适用

A Stepped Wedge Cluster Randomized-control Trial to Improve Child Outcomes Through Caregiving in Cambodia

RTI International2 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3,500
试验地点
2
主要终点
Caregiver Report of Early Development Index (CREDI Instrument) - Child Development

研究概览

简要总结

This study is a longitudinal, randomized-controlled study with a stepped-wedge research design. The Integrated Early Childhood Development Activity (IECD) will implement interventions in three cohorts of villages sequentially across two provinces of Cambodia, Kampong Thom and Preah Vihear. IECD will collect data from all three cohorts together, four times, at 12-month intervals: a baseline prior to any program intervention, a Cohort 1 end line, a Cohort 2 end line and a Cohort 3 end line. IECD's Theory of Change is that by changing caregivers' practices in rearing their children under age 5, those children will demonstrate improvements in child development outcomes. The investigators will use 6 instruments to collect this data, including well-established internationally validated measures. The IECD team enrolled 1,790 households in Preah Vihear and Kampong Thom in June and July 2021. The study will be competed in 2025.

详细描述

IECD's approach is based on the Nurturing Care Framework, which is a globally adopted conceptual framework for inclusive, integrated early childhood development (ECD). The Nurturing Care Framework describes five indivisible elements of support young children need to thrive: nutrition, health, responsive caregiving, early learning, and protection. IECD addresses these five elements cohesively within the broader ecosystem of families, communities, service providers, and the policy environment to achieve optimal child outcomes (Exhibit 1). Through Objective 1 activities, IECD will create optimal conditions for all children's development by building the skills of families, health providers, and community leaders to provide and promote Nurturing Care. Through Objective 2, IECD will address children's physical development by improving families' abilities to produce or procure nutritious foods; by helping families generate income to support livelihoods; by promoting consumption of nutritious diets; and by strengthening the integration hygiene, health services, and ECD services. Under Objective 3, IECD will leverage existing screening tools to identify children at risk for developmental delays and disabilities, increase referrals, and strengthen local capacity to provide specialized care.

At the end of IECD, more Cambodian children will be thriving and meeting key growth and developmental milestones. Households will have made substantive changes in their behavior in providing responsive caregiving, nutritious diets, and a hygienic environment for young children, as well as in increasing their incomes through market-led agriculture. Caregivers of children with developmental delays and disabilities will have increased access to early identification and quality intervention services. Service providers from across sectors will be actively supporting families of young children with and without disabilities to provide nurturing care. Civil society partners and other stakeholders will have a common understanding of nurturing care priorities and will be aligning their activities in support of improved child outcomes. The ecosystem in which families and service providers interact with each other, with the private sector, and with the Royal Government of Cambodia (RGC) will have shifted toward an enabling environment in which all actors prioritize and operationalize quality, integrated ECD services for all young children.

A. IECD will sustainably change caregivers' practices in Nurturing Care by delivering an IECD Nurturing Care curriculum, which targets caregivers' Key Behaviors with respect to nutrition, health and water sanitation and hygiene (WASH), responsive care and early learning, safety and security, and gender equity in the household. For each of these domains, IECD has identified Key Behaviors of caregivers that when implemented consistently have been shown to improve child outcomes. Messages, examples, modeling and practice are all strategies incorporated into the IECD Nurturing Care curriculum to promote behavior change. This Nurturing Care curriculum will be delivered through:

  • Group sessions for caregivers that cover the curriculum in bi-weekly groups (not exceeding 15 people) at the village level, facilitated by Village Health Support Groups (VHSGs), according to session scripts provided by IECD
  • Individualized home visits for most vulnerable households, aligned to the same IECD Nurturing Care curriculum, conducted by VHSGs and tailored to the needs of each household
  • Cross-cutting Social Behavior Change Communication: mass media and interpersonal communication aimed at changing knowledge, attitudes and practices at the community level to support Nurturing Care.

B. IECD will increase access to healthy and nutritious food by building families' capacity to grow and raise healthy food to consume themselves, and by connecting families to agricultural markets so they can generate income. The specific approaches to achieve these outcomes are:

研究设计

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

盲法说明

Data collectors will not know which families have received treatments. The investigators will be masked during analysis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (age 18+) caregivers of one or more child(ren) under the age of 5 years old
  • Adult (age 18+) pregnant women

排除标准

  • 未提供

结局指标

主要结局

Caregiver Report of Early Development Index (CREDI Instrument) - Child Development

时间窗: 12 months

This instrument is used to measure the primary outcome of child development. It is a caregiver-reported questionnaire to measure of developmental status of children aged 6-23 months across developmental domains. The developmental domains are: 1. Motor Skills (fine and gross) 2. Language (receptive and expressive) 3. Cognition (executive function, problem solving \& reasoning, and pre-academic knowledge) 4. Social-Emotional (emotional \& behavioral self-regulation, emotional knowledge, social competence) 5. Mental Health (internalizing, externalizing) The scale score is from 0-20. Higher score is optimal. Developed by Harvard. For more information, see https://sites.sph.harvard.edu/credi/.

Early Childhood Development Indicators (ECDI Instrument) - Child Development

时间窗: 12 months

This instrument is used to measure the primary outcome of child development. It is a caregiver-reported questionnaire to measure of developmental status of children aged 24-59 months across domains of learning, psychological well-being, and health, and 12 sub-domains. The scale score is from 0-20. Higher score is optimal. Developed by UNICEF. For more information, see https://data.unicef.org/resources/early-childhood-development-index-2030-ecdi2030/.

次要结局

  • Integrated Early Childhood Development Caregiving Key Behaviors (ECDI Instrument)(12 months)
  • WHO Minimum Dietary Diversity-Women (MDD-W) Instrument(12 months)
  • World Health Organization Minimum Acceptable Diet Instrument (children aged 6-23 months)(12 months)
  • WHO Prevalence of Exclusive Breastfeeding Instrument (children aged 0-6 months)(12 months)

研究者

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

Katherine Merseth King

Director, Early Childhood Development

RTI International

研究点 (2)

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