Testing Means to Scale Early Childhood Development Interventions in Rural Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,152
- 试验地点
- 2
- 主要终点
- Child Developmental Outcomes
研究概览
简要总结
This study aims to experimentally test the effectiveness and cost-effectiveness of competing models of delivery of an Early Childhood Development (ECD) intervention in rural Kenya to determine how to maximize their reach to improve child cognitive, language and relevant psychosocial outcomes. The study will also include a longer-term evaluation of sustained impacts; an examination of the pathways of change leading to intervention impacts to inform policy; and examination of the role of paternal involvement on child development. Findings will provide policy makers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings to improve child developmental outcomes for both the short-and longer-term.
详细描述
Recent neurobiological and psychological research has established that vital development occurs in language, cognitive, motor and socio-emotional development during the first few years of life, and early life outcomes are key determinants of adult outcomes such as educational achievement, labor market outcomes, and health. Yet more than 200 million children under age five in low and middle income countries (LMICs) will fail to reach their developmental potential as adults, predominantly due to poverty, poor health and nutrition, and inadequate cognitive and psychosocial stimulation. Early childhood development (ECD) interventions that integrate nutrition and child stimulation activities have been proposed as a powerful policy tool for the remediation of early disadvantages in poor settings, and numerous field studies have shown they can be effective in improving children's developmental and health outcomes, at least in the short-term. Key questions remain on what models of delivery are the most effective and cost-effective that can be potentially scalable in LMICs, as well as how to sustain parental behavioral changes over time, which can lead to long-term improvements in child development and the possibility of positive spillovers to benefit younger siblings. Having a better understanding of the underlying behavioral pathways leading from intervention, to parental behavior changes, to child impacts, is also key to inform policy about the optimal design of interventions to maximize their scalability and sustainability. This study will conduct a multi-arm clustered randomized controlled trial across 60 villages and 1200 households in rural Western Kenya that tests different potentially cost-effective delivery models for an ECD intervention with a curriculum that integrates child psychosocial stimulation and nutrition education. Selected households will undergo baseline and follow-up surveys to measure short-term impacts in parental behaviors and children's developmental outcomes, and the study will collect data on potential mediators of parental behavioral change to uncover the pathways leading to impacts. Two follow-up surveys, one immediately after the end of the planned intervention and a second two years later, will enable testing of the short term and midterm sustainability of impacts, as well as the presence of any spillovers onto younger siblings. In collaboration with a local non-governmental organization (NGO), the Safe Water and AIDS Project (SWAP), community health volunteers (CHVs) will be trained to implement the intervention by introducing the ECD curriculum in their villages.
The goal of this study is to provide policymakers with rigorous evidence of how best to expand ECD interventions in low-resource rural settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study will have separate teams for collection of surveys and program implementation. Due to the nature of the intervention, the participants and delivery agents will not be blinded to their study allocation as part of the program implementation team. Data collectors of surveys for the research team will, however, be blinded to the intervention allocation status of participants and villages. (Baseline surveys will be collected prior to randomization.) Likewise, data analysis will be blinded to the intervention status of participants and villages.
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Kenyan mothers or equivalent female primary caretakers aged 15 and over with children aged 6-24 months (classified as mature minors)
- •Kenyan fathers aged 18 and older with children aged 6-24 months with a mother present
- •The unit of observation for the study is the household or family, within which the primary focus is mother-child dyads and household eligibility hinges on the age of the child. For those households with a father present, the study will additionally include him in some analyses and surveys.
排除标准
- •Households without children
- •Households with children that are outside the age range of 6-24 months at baseline
- •Households with a mother younger than 15 or one aged 15-18 still living with her parents
- •Single fathers
- •Selection criteria for fathers are based on the mother-child eligibility criteria. Fathers will be included if and when appropriate per the details surrounding the mother-child dyads.
结局指标
主要结局
Child Developmental Outcomes
时间窗: Month 35-37/Follow-Up survey (Arms 3, A and B), two years after end of Phase 1's 16 biweekly sessions
Block-design subtest of the Wechsler Preschool and Primary Scale of Intelligence - 4th Edition (WPPSI-IV) to measure cognitive non-verbal reasoning. This subtest produces an age-standardized scaled score that can range from 1 to 19, with higher scores denoting better outcomes. For expressive and receptive language we used Dholuo and Kiswahili versions of the British Picture Vocabulary Scale - III (BPVS III), which includes 168 items for use with ages 3-17 years old. Knowledge of receptive vocabulary is measured by asking the respondent to point to one of four pictures that corresponds to a word (object, person, or action) spoken by the assessor; for expressive vocabulary the assessor pointed to a picture and the child named it. Pictures were adapted to the Kenyan context previously. Raw language scale ranges 0-25 with higher values denoting better outcomes.
Parenting Practices (HOME Observation for Measurement of the Environment - HOME)
时间窗: Month 35-37 Follow-up Survey (Arms 3, A and B).
At follow-up surveys, the study will collect the Home Observation for Measurement of the Environment (HOME)- Short Form (SF) inventory. The HOME-SF includes items grouped into two sub-scales: emotional support and cognitive stimulation. It has four parts: one for children under age three; a second for children between the ages of three and five; a third for children ages six through nine; and a fourth version for children ten and over. The total raw score for the HOME-SF is a simple summation of the recorded individual item scores and it varies by age group, as the number of individual items varies according to the age of the child. At the month 35-37/follow-up survey the HOME score ranged 0-55 with higher scores denoting better outcomes.
次要结局
- Changes in Nutritional Practices(Month 11/endline survey (Arms 1, 2 with and without fathers, and Arm 3), and follow-up 2/month 35-37 survey (Arms 3, A and B).)
- Child Height(Month 11/endline survey.)
研究者
Jill Luoto
Research Scientist
University of Southern California
