Evaluate the effect of home-based safety educational intervention package on unintentional childhood injuries of under-five children among primary caregivers in selected rural areas of Belagavi, North Karnataka. A Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi.
研究概览
简要总结
My study aims to “ evaluate the effect of home-based safety educational intervention package on unintentional childhood injuries of under-five children among primary caregivers in selected rural areas of Belagavi, North Karnataka. A Cluster Randomized Control Trial”. The objectives of the study are to evaluate the effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi. To estimate the prevalence of unintentional childhood injuries of under-five children in rural areas of Belagavi. To assess the hazards posed by the home environment and their association with unintentional childhood injury patterns among under-five children.Quantitative Evaluative approach. The study will be planned in two phases. Phase I is to identify the prevalence of unintentional childhood injury among under-five children between 1 year to 5 years of 1000 house hold children. Phase II of the study will be a randomized controlled trial.In Phase IMultistage Cluster randomization technique. PHC will be considered as clusters and houses in the village as cluster units. In Phase II A random allocation will be carried out at the level of selection of villages by simple random sampling by lottery method to the intervention and control group of 120 house hold children.The outcome of the study: The primary outcome of the study was to assess the prevalence of unintentional childhood injuries in the previous three months. The Environmental Home Hazard Assessment form to observe the home hazards in the house and will be categorized by Low risk, Medium risk, and High risk. Primary Caregiver Knowledge and attitudes (PCA) towards child safety. Unintentional childhood injuries during 3 months follow up.Statistical analysis by descriptive statistics (mean, SD, frequency, and %), Chi-square test for association. Repeated measures of ANOVA followed by Tukeys multiple posthoc procedures. Independent t test or Mann-Whitney U test for inter group comparison. Dependent t test or Wilcoxon matched pairs test intra group comparison. A significance will be set at 5% level of significance (p<0.05)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between one to five years of age.
- •Families residing in the study area for more than six months preceding the study.
- •In case of more than one eligible child in the household, the youngest child will be included.
- •Caregivers of children who can read, write, and understand the local language.
排除标准
- •Critically ill children will be excluded from the study.
结局指标
主要结局
effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi.
时间窗: 1 year
次要结局
- Estimate the prevalence of unintentional childhood injuries of under-five children in rural areas of Belagavi.(Assess the hazards posed by the home environment and their association with unintentional childhood injury patterns among under-five children.)
研究者
Jagadeesh Hubballi
KAHER. Belagavi