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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Jagadeesh GHubballi
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi.
Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •Critically ill children will be excluded from the study.
Outcomes
Primary Outcomes
effect of home-based safety educational intervention package among primary caregivers of under-five children in rural areas of Belagavi.
Time Frame: 1 year
Secondary Outcomes
- 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.)
Investigators
Jagadeesh Hubballi
KAHER. Belagavi