跳至主要内容
临床试验/NCT02234726
NCT02234726已完成不适用

Improving Early Childhood Development in Zambia

Zambia Center for Applied Health Research and Development2 个研究点 分布在 1 个国家目标入组 526 人开始时间: 2014年8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
526
试验地点
2
主要终点
Stunting

研究概览

简要总结

The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.

Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households.

详细描述

The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on child physical and cognitive development. Central to the ECD program is a cadre of community-based health workers called Child Development Agents (CDAs). CDAs have four main tasks and responsibilities: 1) Biweekly screening and management (including referral) of acute malnutrition in children; 2) Encouragement of caregivers to utilize routine care services for children (immunizations, growth monitoring, and vitamin A supplementation); 3) Screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) Organization and mentoring of weekly meetings for caregivers to discuss parenting issues and promote early childhood cognitive stimulation.

Protocols for the community-based evaluation and management of children with acute malnutrition are based on the draft Zambian Community Integrated Management of Acute Malnutrition (CIMAM) guidelines. Children with complicated severe acute malnutrition (SAM) are referred to the nearest health center for evaluation and, if SAM is confirmed based on mid-upper arm circumference (MUAC), then referred to an inpatient feeding center for management. All children with moderate acute malnutrition (MAM) and uncomplicated SAM are administered an appetite test at the health center. Children who pass the appetite test are managed locally as outpatients. Children with acute infectious diseases are treated following the Ministry of Health's adaptation of the Integrated Management of Childhood Illness (IMCI) guidelines and those with complicated SAM or feeding difficulties are referred to higher level facilities (feeding centers). As part of the ECD program, clinical staff members at study health centers receive a short training to improve their adherence to IMCI and CIMAM guidelines.

One aspect of the IECDZ program that is of particular interest from a policy and evaluation perspective is the explicit focus on improving communication between CDAs and clinical staff at facilities handling undernourished children. As part of the ECD program, CDAs meet with staff at referral health centers on a regular basis, and discuss strategies to improve nutritional outcomes of children falling behind.

In addition to these regular meetings, the ECD program strengthens the linkages between CDAs and health centers with a novel mHealth intervention. When a CDA refers a child to a health center for evaluation of acute malnutrition, danger signs, or signs/symptoms suggestive of malaria, pneumonia or diarrhea, the officer-in-charge at the health center receives an short message service (SMS) and a paper referral form to make them aware of the child and their provisional diagnosis. Once the referred child has been attended to at the facility, health center staff members will then send an SMS back to the CDA to make them aware of the final diagnosis and management plan. If the health center refers the child to a feeding center, an SMS is sent to the feeding center along with a paper referral form. All text messages within the proposed system are free of charge to the end users. The mobile health (mHealth) system is meant to improve communication between health workers operating at various levels of the health system. Caregivers themselves do not receive SMS updates. Rather, CDAs will communicate all updates on the health and nutritional status of children directly to caregivers.

The primary objectives of the ECD program are to:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
6 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child ages 6 to 12 months at the time of intervention launch residing in the catchment areas of the five study health facilities
  • Child's mother or main caregiver must be 15 years or older
  • Child's primary caregiver must be a female (because the participants in the caregiver groups may feel uncomfortable discussing certain issues if a man is present)

排除标准

  • Caregivers who are unwilling to provide informed consent
  • Families that plan to move from their health center catchment zone during the twelve month period of the study

结局指标

主要结局

Stunting

时间窗: One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline

Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard WHO criteria. Stunting will be defined as having a height-for-age z-score \< -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined.

Cognitive function

时间窗: End line (after one year); Amendment: BSID-III at year two (extension) endline

Study children will be assessed at end line using the INTERGROWTH 21st century instrument. Scores will be standardized within the study sample for analysis. Scores of children in intervention health zones will be compared with children in comparison areas to determine differences. Amendment: at year two (extension) endline, children are assessed using the Bayley Scale for Infant and Toddler Development (BSID-III). Scores are standardized within the study sample for analysis.

次要结局

  • Treatment of severe acute malnutrition (SAM)(Baseline and end line (one year))
  • Caregiver awareness of child development(Baseline and end line (one year))
  • Measles vaccine 2nd dose(End line (one year))

研究者

发起方
Zambia Center for Applied Health Research and Development
申办方类型
Other
责任方
Sponsor

研究点 (2)

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