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Abstract Background Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn—Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility. Methods EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent–child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is “school readiness”, assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders’ perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Discussion This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities. Trial registration The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).

Background Maternal post-natal depression is a global public health problem. Parenting interventions targeting children’s development may also bring benefits to mothers, but few parenting interventions have been studied thoroughly. Objectives The study aimed to measure the effect of a parenting intervention using culturally appropriate and locally made toys, along with nutrition education and unconditional cash, on maternal depressive symptoms (MDS) and quality of life (QoL). Methods The study was a cluster randomised controlled trial with two arms: i) intervention: parenting with nutrition education and unconditional cash and ii) comparison: unconditional cash in an urban setting in Bangladesh. Twenty clusters were randomised to either the intervention or control group. Community Health Workers (CHWs) delivered parenting and nutrition education sessions fortnightly in households for one year. The participants were mother-child (6–16 months) dyads. The MDS and QoL were measured using the Self-Reporting Questionnaire-20 and a brief version of the QoL questionnaire. Linear regression analysis was used to assess the treatment effects. Results After one year of intervention, 547 mothers (93%) completed the study. The mothers in the intervention group had lower MDS [Regression coefficient (β)=-1.53, Confidence interval (95% CI)=-2.28, −0.80] and higher QoL scores in physical health [β = 4.21 (95% CI = 1.71, 6.73)], psychological health [β = 3.14 (95% CI = 1.10, 5.19)], social relationships [β = 3.21 (95% CI = 0.76, 5.66)] and environment [β = 3.40 (95% CI = 1.37, 5.44)] compared with the comparison group. Conclusion Parenting interventions including nutrition education and unconditional cash, aimed at improving children’s development, resulted in a reduction in maternal depressive symptoms and improvement in quality of life.

Summary: Background: Although sustainable development goals mandate for quality early childhood development (ECD) interventions for children

BackgroundThe aim of this study is to assess if peer counseling of women improves breastfeeding, complementary feeding practices, and child growth, and thus reduces the prevalence of undernutrition in children up to 4 years of age. ObjectiveLack of exclusive breastfeeding and inappropriate complementary feeding are critical factors in reducing child undernutrition, morbidity, and mortality. There are reported trials of peer counseling to improve breastfeeding; however, they did not examine the efficacy of peer counseling to improve complementary feeding or the long-term impacts on child growth and development. MethodsThis study has used a community-based, cluster-randomized controlled trial with a superiority design and 2 parallel treatment arms. It is assessing the impact of peer counseling, starting in late pregnancy up to 1 year after delivery, on child feeding practices, growth, and development with follow-up until 48 months of age. The study site was Mirpur, a densely populated area in Dhaka. Using satellite maps and geographic information system mapping, we constructed 36 clusters with an average population of 5000 people. We recruited pregnant women in the third trimester aged 16-40 years, with no more than 3 living children. Trained peer counselors visited women at home twice before delivery, 4 times in the first month, monthly from 2 to 6 months, and again at 9 and 12 months. Trained research assistants collected anthropometric measurements. The primary outcome will be differences in child stunting and mean length for age at 6, 12, 15, and 18 months. Secondary outcomes will be differences in the percentage of women exclusively breastfeeding in the mean duration of any breastfeeding and in the percentage of children at 6 and 9 months of age who receive solid, semisolid, or soft foods; and the percentage of children consuming foods from 4 or more food groups at 9, 12, 15, and 18 months. We will assess the mean cognitive function scores from the Ages and Stages Questionnaire (9 and 18 months) and Bayley tests (24 and 36 months). ResultsWe identified 65,535 people in mapped residences, from which we defined 36 clusters and randomly allocated them equally to intervention or control groups stratified by cluster socioeconomic status. From July 2011 to May 2013, we identified 1056 pregnant women and 993 births in the intervention group and 994 pregnancies and 890 births in the control group. At 18 months, 692 children remained in the intervention group and 551 in the control group. From January 2015 to February 2017, we conducted the long-term follow-up of the cohort. We have now completed the data collection and processing and have started analyses. ConclusionsThis study will help fill the evidence gap about the short- and long-term impact of peer counseling on improving infant feeding, preventing childhood undernutrition, and enhancing child cognitive development. Trial RegistrationClinicalTrials.gov NCT01333995; https://clinicaltrials.gov/ct2/show/NCT01333995 International Registered Report Identifier (IRRID)DERR1-10.2196/31475

The accuracy of haemoglobin concentration measurements is crucial for deriving global anaemia prevalence estimates and monitoring anaemia reduction strategies. In this analysis, we examined and quantified the factors affecting preanalytic and analytic variation in haemoglobin concentrations. Using cross-sectional data from three field studies (in children, pregnant and nonpregnant women), we examined the difference in haemoglobin concentration between venous-drawn and capillary-drawn blood measured by HemoCue (ie, preanalytic) and modelled how the bias observed may affect anaemia prevalence estimates in population surveys and anaemia public health severity classification across countries. Using data from an international quality assurance programme, we examined differences due to instrumentation from 16 different haematology analyzers (ie, analytic). Results indicated that capillary and venous haemoglobin concentrations are not in agreement (bias +5.7 g/L (limits of agreement (LoA) −11.2, 22.6) in preschool age children; range from −28 g/L to +20 g/L in pregnant women; bias +8.8 g/L (LoA −5.2, 22.9) in non-pregnant women). The bias observed could introduce changes in population survey estimates of anaemia of up to −20.7 percentage points in children and −28.2 percentage points in non-pregnant women after venous adjustment. Analytic variation was minimal and unlikely to influence the diagnosis of anaemia. These findings suggest that global estimates of anaemia prevalence derived from capillary haemoglobin, as they often are, may be inaccurate and lead to erroneous public health severity classification, but that point-of-care, or other, instruments should not introduce variation if properly used.

Objective: Community day-care centers (or crèches) are gaining popularity; access to these centers can reduce cognitive gaps. This paper describes the sustained impact of enrollment in day-cares on cognitive gains. Methods: As part of a larger study, a census of all children was conducted in 2012–2013 to identify children between 9 and 17 months of age in rural Bangladesh. A sub-sample of children (n = ~1000) were assigned to receive either a day-care or playpen. Children from two sub-districts were randomly selected and assessed at 9–17 months of age for cognitive and behavioral domains using the Ages and Stages Questionnaire-III. The same children were then followed-up with after one year to see if the scores obtained by the children in the day-care intervention were different from those enrolled in the playpen intervention using a difference-in-difference estimator. Results: Children enrolled in the day-care intervention performed better (in communication, gross-motor, personal-social, and problem-solving domains) than children enrolled in the playpens when followed up with after a one-year period. Total scores were 0.31 (95% CI 0.141–0.472) higher (p value < 0.001) among children in the day-cares. Family care indicators as well as the child’s and mother’s weight were significantly associated with sustained and increased cognitive gains. Conclusion and relevance: The cognitive and psychosocial improvements seen with short-term exposure to structured ECD programs (day-care) were observed to be sustained over time with continued exposure. Home stimulation and parental involvement add to the long-term benefits of ECD.

Background: Our studies of children in a rural Bangladeshi area, with varying concentrations of arsenic in well-water, indicated modest impact on child verbal cognitive function at 5 years of age. Objectives: Follow-up of arsenic exposure and children’s cognitive abilities at school-age. Methods: In a nested sub-cohort of the MINIMat supplementation trial, we assessed cognitive abilities at 10 years of age (n = 1523), using Wechsler Intelligence Scale for Children (WISC-IV). Arsenic in maternal urine and erythrocytes in early pregnancy, in child urine at 5 and 10 years, and in hair at 10 years, was measured using Inductively Coupled Plasma Mass Spectrometry. Results: Median urinary arsenic at 10 years was 58 µg/L (range 7.3–940 µg/L). Multivariable-adjusted regression analysis showed that, compared to the first urinary arsenic quintile at 10 years (

Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database. Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.

Introduction Early childhood development can be described by an underlying latent construct. Global comparisons of children’s development are hindered by the lack of a validated metric that is comparable across cultures and contexts, especially for children under age 3 years. We constructed and validated a new metric, the Developmental Score (D-score), using existing data from 16 longitudinal studies.Methods Studies had item-level developmental assessment data for children 0–48 months and longitudinal outcomes at ages >4–18 years, including measures of IQ and receptive vocabulary. Existing data from 11 low-income, middle-income and high-income countries were merged for >36 000 children. Item mapping produced 95 ‘equate groups’ of same-skill items across 12 different assessment instruments. A statistical model was built using the Rasch model with item difficulties constrained to be equal in a subset of equate groups, linking instruments to a common scale, the D-score, a continuous metric with interval-scale properties. D-score-for-age z-scores (DAZ) were evaluated for discriminant, concurrent and predictive validity to outcomes in middle childhood to adolescence.Results Concurrent validity of DAZ with original instruments was strong (average r=0.71), with few exceptions. In approximately 70% of data rounds collected across studies, DAZ discriminated between children above/below cut-points for low birth weight (

Background & Aim: Intimate partner violence (IPV) is highly prevalent in Bangladesh especially in lower socioeconomic groups. The aim of this research was to identify the prevalence and nature of IPV and determine its association with young children‟s behavior in urban slums. Methods & Materials: This cross-sectional survey was conducted on married women with at least one child aged 4-5 years and living with the father of that child (n = 182). The socioeconomic status (SES) questionnaire, the Strengths and Difficulties Questionnaire (SDQ), and IPV questionnaire were used to collect data. The SDQ consists of 4 subscales of difficulties and 1 prosocial subscale. Bivariate correlations and multiple regression analysis were conducted to determine the association of SDQ with IPV. Results: Almost 90% of women had at least once experienced any type of IPV. Some married women had experienced all types of physical, emotional, and sexual violence by their husband throughout their married life. Children, whose mothers experienced IPV, had higher scores of total difficulties on SDQ as well as emotional symptoms and conduct problems compared to those whose mothers did not experience IPV. The study showed that 1 unit increase in emotional violence by the intimate partner independently led to the increase of the total difficulties score by 0.60 units and the emotional symptom problems by 0.28 units (P ≤ 0.05). The regression models showed the 1 unit increase in physical violence by the intimate partner predicted an increase of 0.59 units in the child‟s total difficulties scores (P ≤ 0.05). Conclusion: IPV is widely prevalent in Bangladesh and affects children‟s behavior. The implications for developing policy to educate and intervene are immense and emphasis must be placed on the age appropriate development of exposed children.

BACKGROUND: Elevated exposure to the essential element manganese (Mn) can be toxic. Manganese concentrations in ground water vary considerably, and reported associations between Mn and early-life mortality and impaired development have raised concern. We assessed the effects of drinking water Mn exposure during pregnancy upon fetal and infant survival. METHODS: In this population-based cohort study, we identified the outcomes of pregnancies registered between February 2002 and April 2003 in Matlab, Bangladesh. Using inductively coupled plasma mass spectrometry, we measured the concentrations of Mn and other elements in the pregnant women's drinking water. RESULTS: A total of 1,875 women were included in the analysis of spontaneous abortions (n=158) and 1,887 women in the perinatal mortality analysis (n=70). Water Mn ranged from 3.0-6,550 µg/L (median=217 µg/L). The adjusted odds ratio (OR) for spontaneous abortion was 0.65 (95% CI 0.43-0.99) in the highest water Mn tertile (median=1,292 µg/L) as compared to the lowest tertile (median=56 µg/L). The corresponding OR for perinatal mortality was 0.69 (95% CI 0.28-1.71), which increased to 0.78 (95% CI 0.29-2.08) after adjustment for BMI and place of delivery (home/health facility; n=1,648). CONCLUSIONS: Elevated water Mn concentrations during pregnancy appear protective for the fetus, particularly in undernourished women. This effect may be due to the element's role in antioxidant defense.

Background: The Benefits and Risks of Iron interventionS in Children (BRISC) trial will evaluate the impact of universal supplementation with iron supplements or iron-containing multiple micronutrient powders (MNPs) compared with placebo given for 3 months on child development, growth, morbidity, laboratory indices of anaemia, iron deficiency, and inflammation at end of intervention and after a further 9 months post intervention in children aged 8 months living in rural Bangladesh. This paper describes the statistical analysis plan. Methods: BRISC is a multi-site, three-arm, double-dummy blinded, parallel group, randomised control superiority trial in 3300 children. The statistical analysis plan was developed by the trial statistician in consultation with the trial steering committee and trial management committee based on the protocol, data collection forms, and study outcomes available in the blinded study database. Conclusion: This detailed statistical analysis plan published prior to unblinding the allocated treatments will support the statistical analyses and reporting of the BRISC trial to be undertaken after unblinding. It allows for transparency as well as reproducibility of statistical analyses and reporting. Registration: Australian New Zealand Clinical Trials Registry ACTRN12617000660381 (registered on 8 May 2017); World Health Organization Universal Trial Number U1111-1196-1125.