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临床试验/NCT06140017
NCT06140017进行中(未招募)不适用

Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

University of Southern California2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2023年10月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,200
试验地点
2
主要终点
Child Cognitive Development - Bayley

研究概览

简要总结

An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term.

The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
4 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mothers or other primary caretakers aged 18 years or older
  • able to read English or Swahili at a level sufficient to understand the SMS messages
  • with a child aged 6-18 months at recruitment without signs of severe mental or physical impairments (youngest child if more than one eligible for a given mother)

排除标准

  • mothers/households without children
  • households with children that are outside the age range of 6-18 months at baseline
  • mothers who lack basic literacy so as not to understand SMS messages

研究组 & 干预措施

In-Person Group Delivery

Active Comparator

A total of 30 villages will receive a traditional in-person group-based delivery for Msingi Bora, an ECD parenting intervention featuring 16 biweekly village sessions over 8 months, followed by monthly "booster" meetings for 16 additional months. Sessions will be delivered within by existing village Community Health Volunteers (CHVs). Mothers and children will be invited to attend a total of 32 in-person sessions of roughly 1.5-2 hours apiece over 24 months.

干预措施: Msingi Bora responsive parenting and family wellbeing program (Behavioral)

Hybrid mHealth/In-Person Group Delivery

Experimental

30 CHVs will deliver a hybrid intervention that combines in-person meetings with remote delivery for Msingi Bora, an ECD parenting intervention. Mother-child dyads will be invited to participate in roughly 10 in-person group sessions in the first 8 months, followed by 5 in-person group sessions over the next 16 months. For those sessions delivered remotely, mothers will receive videos demonstrating the practices, SMS messages, be invited to participate in group SMS/WhatsApp chats with the CHV and other village mothers, and periodic phone calls. The project will provide smartphones to all mothers assigned to this arm for facilitation.

干预措施: Msingi Bora responsive parenting and family wellbeing program (Behavioral)

Control Group

No Intervention

Mothers and children in 30 villages will not receive any intervention beyond information about child feeding during a baseline survey.

结局指标

主要结局

Child Cognitive Development - Bayley

时间窗: Midline/8-month survey, Endline/24-month survey

The Bayley Scales of Infant Development 3rd edition (Bayley's III) is validated in African settings and provides measures for all dimensions of child development up to 42 months of age. The official age-standardized cognitive scale has a 0-19 range with higher values denoting better scores.

次要结局

  • Parenting Behaviors(Midline/8-month survey, Endline/24-month survey)

研究者

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

Italo Lopez Garcia

Principal Investigator

University of Southern California

研究点 (2)

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