RESULTS
SE
From November 10, 2017 to March 7, 2018, 804 children aged 12 months (±15 days) were recruited in 22 public health facilities. The last follow-up was completed on February 26, 2019. There was a similar loss to follow-up in both arms: 14 (3.5%) mother-child pairs in the intervention arm and 12 (3%) mother-child pairs in the control arm. Baseline Characteristics of Clusters and Participants in the Integrated Early Childhood Development Care Intervention, Punjab, PakistanAbbreviations: PKR, Pakistan rupee; SD, standard deviation.The primary outcome analysis shows that the intervention arm had a significantly lower proportion of global (2 or more) development delays in children aged 24 months compared to the control arm (difference: 28 percentage points; The primary outcome analysis shows that the intervention arm had a significantly lower proportion of global development delays in children aged 24 months compared to the control arm.The proportions of children with developmental delay in each of the 5 domains of child development measured by ASQ were significantly less in the intervention arm as compared to the control arm. The odds of children developing a developmental delay in any 1 of the 5 child development domains were also significantly lower in the intervention arm.Mean scores on 5 domains of child development were measured by ASQ and were individually above the cutoff scores for developmental delays in both arms at the endpoint. The mean scores were higher in the intervention arm, and the mean difference in scores across arms was significant. Intervention effects on the continuous outcomes of ASQ were significant for all domains of child development, indicating the effectiveness of the ECD intervention in improving child development. Monitoring of follow-up sessions indicated around 84% (95% CI=0.82, 0.86) of mothers attended all follow-up sessions, while only 62% (95% CI=0.55, 0.69) of mothers in the control arm attended all follow-up sessions (Primary Outcome Analyses of the Integrated Early Childhood Development Care Intervention in Punjab, PakistanAbbreviations: CI, confidence interval; PP, percentage point; SD, standard deviation; SE, standard error.Arm-specific proportions and their 95% CIs are based on cluster-level summary outcomes.Odds ratio are calculated using generalized estimating equations on 778 observations.The anthropometric measurements of children at the endpoint also indicated better physical child growth (i.e., z-scores for height-for-age, weight-for-age, and weight-for-height were significantly better in the intervention arm as compared to the control arm) (Secondary Outcome Analyses of the Integrated Early Childhood Development Care Intervention in Punjab, PakistanAbbreviations: CI, confidence interval; SE, standard error.Arm-specific proportions and their 95% CIs are based on cluster-level summary outcomes.Odds ratio are calculated using generalized estimating equations on 778 observations.The effect modification analysis by sex on the primary outcome (i.e., the proportion of children with 2 or more delays) showed an insignificant difference in results among both sexes, thus implying that the primary outcome does not differ significantly by the sex of the child.