Integrating Early Stimulation and Play at Scale: "MAHAY Mikolo", a Multi-arm Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,150
- 试验地点
- 2
- 主要终点
- Caregiver-child attendance in ECD group sessions
研究概览
简要总结
The overall objective of the study is to examine the effects of integrating early child development group sessions into the existing, at-scale, community health and nutrition programs administered by the government in Madagascar.
详细描述
This research is a cluster-randomized trial that will assess the effects of integrating early child development activities on community health worker time use and caregiver time use and participation in the program. The evaluation will compare the addition of early child development sessions to the status quo health and nutrition program, with an additional intervention arm looking at the addition of toys to the program.
This study has four objectives, which will be measured at the community health worker level, and at the caregiver level for caregiver-child dyads (where children are between 6-30 months old at time of intervention launch):
- Measure how the integration of ECD activities with standard nutrition programming affects the time and task allocation of the community health workers
- Measure the extent, if any, that the addition of ECD activities crowds out community health worker health/nutrition tasks that are part of the standard community program
- Measure how the integration of ECD activities affects rates of caregiver participation in nutrition and health activities over time (e.g., during changes in seasonal activities).
- Measure the impact of enhanced availability and maintenance of age-appropriate play materials/activities on sustained caregiver participation rates in the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The investigators that are analyzing the data are blinded to treatment assignment during analysis.
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for communities:
- •No other ECD programs present in the community or neighboring communities;
- •At least 40 children monitored at the nutrition center in the target age range of 6-30 months (monitored is defined as attending at least one growth monitoring session between July 2019 to August 2020);
- •Stable supervisory presence. Local NGOs are contracted to monitor and supervise all community health workers and help to strengthen linkages with local structures such as the community health committees and primary care facilities. Each NGO supervisor is in charge to up to 9 communities, which they visit twice a month. The investigators defined stable presence as not having had NGO turnover within the last year.
- •Among the communities included, children 6-30 months were eligible to participate in the intervention. There was no inclusion criteria for community health workers.
排除标准
- 未提供
研究组 & 干预措施
Treatment + (T+): Enhanced play materials/activities package
干预措施: Treatment + (T+) (Behavioral)
Control (C): Status quo health and nutrition program
Treatment (T): adaption of Reach Up and Learn home visiting program to a group setting
干预措施: Treatment (T) (Behavioral)
结局指标
主要结局
Caregiver-child attendance in ECD group sessions
时间窗: Up to 12 months
Monthly attendance in ECD sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
Community health worker time use
时间窗: Up to 12 months
Proportion of working day spent on community health worker activities, measured through recall of hourly time use using monthly phone surveys
Caregiver-child attendance in health and nutrition sessions
时间窗: Up to 12 months
Monthly attendance in health and nutrition sessions, measured through session attendance records (0 = Did Not Attend, 1 = Attended)
次要结局
- Community health worker stress(Up to 12 months)
- Community health worker depressive symptoms(Up to 12 months)