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临床试验/CTRI/2025/07/091314
CTRI/2025/07/091314尚未招募不适用

Effectiveness of Group counselling and home visits for Early Childhood Development among children aged 0-3 years in urban slums of Bhubaneswar: A cluster Randomised trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
176
试验地点
1
主要终点
1. Children’s development as per their age (Gross Motor, Fine Motor, Communication/social, cognitive development),

研究概览

简要总结

This cluster-randomised trial aims to evaluate the effectiveness of structured group counselling and regular home visits by trained frontline workers (AWWs, ASHAs, ANMs) in promoting early childhood development (ECD) among children aged 0–3 years living in urban slums of Bhubaneswar. Sixteen Anganwadi Centres (AWCs) will be randomly assigned to either the intervention or control arm. The intervention includes training FLWs and MAS members on ECD modules, followed by monthly group counselling sessions of parents and home visits over a 9-month period. Developmental milestones, anthropometric growth, will be measured at 3rd, 6th and 9 the month of the baseline survey and morbidity of children will be assessed at baseline and endline. Additionally, knowledge and attitudes of FLWs and caregivers toward ECD will be evaluated. This study uses existing health infrastructure and workforce, making it scalable and policy-relevant for similar low-resource urban settings.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 36.00 Month(s)(—)
性别
All

入选标准

  • All the children aged 0-3 years whose family is residing in the particular slum for more than 1 year and the child/ mother is being enrolled in the respective AWC who will give consent to participate in the study will be included.

排除标准

  • Children with physical and mental disability Mothers/ caregivers with terminally ill and not able to comprehend.

结局指标

主要结局

1. Children’s development as per their age (Gross Motor, Fine Motor, Communication/social, cognitive development),

时间窗: 3 months | 6 months | 9 months

2. Growth of children (Anthropometric measurements), and

时间窗: 3 months | 6 months | 9 months

3. Morbidity pattern among children in last 9 moths

时间窗: 3 months | 6 months | 9 months

次要结局

  • Secondary outcome:(1. Difference in knowledge and attitude of ASHA, AWW, ANM and MAS members towards ECD)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Prajna Paramita Giri

All India Institute of Medical Sciences Bhubaneswar Odisha

研究点 (1)

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