Using Implementation Research to Inform Scaling of Parenting Programs: Independently Conducted Case Studies from Zambia and Bhutan.

Two case studies of parenting programs for parents of children 0 to 36 months of age, developed and implemented by Save the Children/Ministry of Health/Khesar Gyalpo University in Bhutan and UNICEF Zambia, were conducted by an independent research group. The focus was on how program delivery and scale-up were revised on the basis of feedback from implementation research. Feedback on workforce delivery quality was based on observations of deliveries using a monitoring form, as well as survey and interview data collected from the workforce. In-depth interviews with the resource team during the fourth year of implementation revealed how the feedback was used to address horizontal and vertical scaling. Delivery quality was improved in some cases by revising the delivery manual, offering refresher courses, and instituting regular monitoring. Scaling challenges in Zambia included slow progress with regard to reaching families in the two districts, which they addressed by trialing group sessions, and stemming workforce attrition. The challenges in Bhutan were low attendance and reducing the workload of providers. Vertical scaling challenges for both countries concerned maintaining demand through continuous advocacy at community and government levels to sustain financing and to show effectiveness in outcomes.

Workforce preparation for delivery of nurturing care in low- and middle-income countries: Expert consensus on critical multisectoral training needs.

BACKGROUND: Services to support nurturing care through early childhood development (ECD) in low- and middle-income countries are hampered by significant workforce challenges. The global early childhood workforce is both diverse and complex, and it supports the delivery of a wide range of services in extremely diverse geographical and social settings. In the context of contemporary global goals for the universal provision of quality early childhood provision, there is an urgent need to build appropriate platforms for strengthening and supporting this workforce. However, the evidence base to support this work is severely limited. METHODS: To contribute to evidence on how to strengthen the ECD workforce in low- and middle-income countries, this study used a Delphi methodology involving three rounds of data collection with 14 global experts, to reach consensus on the most critical training needs of three key early childhood workforce groups: (i) health; (ii) community-based paraprofessionals, and (iii) educational professionals working across ECD programmes. RESULTS: The study identified a comprehensive set of shared, as well as distinct, training needs across the three groups. Shared training needs include the following: (i) nurturing dispositions that facilitate work with children and families in complex settings; (ii) knowledge and skills to support responsive, adaptable delivery of ECD programmes; and (iii) systems for ECD training and professional pathways that prioritise ongoing mentoring and support. CONCLUSIONS: The study's detailed findings help to address a critical gap in the evidence on training needs for ECD workers in low-resource contexts. They provide insights into how to strengthen content, systems, and methods of training to support intersectoral ECD work in resource-constrained contexts.

A Tale of Two Programs for Parents of Young Children: Independently-Conducted Case Studies of Workforce Contributions to Scale in Bhutan and Rwanda.

Two case studies of parenting programs, aiming to improve parenting practices and child development outcomes, and implemented by Save the Children/Ministry of Health/Khesar Gyalpo University in Bhutan and Boston College/University of Rwanda/FXB in Rwanda, respectively called Prescription to Play and Sugira Muryango, were conducted by an independent research and learning group. Implementation research focused on the workforce, a crucial but little-studied element determining the success of programs going to scale. Mixed methods were used to examine their training, workload, challenges, and quality of delivery. Health assistants in Bhutan and volunteers in Rwanda were trained for 10-11 days using demonstrations, role plays, and manuals outlining activities to deliver to groups of parents (Bhutan) or during home visits (Rwanda). Workers' own assessments of their delivery quality, their confidence, and their motivations revealed that duty, confidence, and community respect were strong motivators. According to independent observations, the quality of their delivery was generally good, with an overall mean rating on 10 items of 2.36 (Bhutan) and 2.44 (Rwanda) out of 3. The facilitators of scaling for Bhutan included institutionalizing training and a knowledgeable workforce; the barrier was an overworked workforce. The facilitators of scaling for Rwanda included strong follow-up supervision; the barriers included high attrition among a volunteer workforce.

Implementation of UNICEF and WHO's care for child development package: Lessons from a global review and key informant interviews.

Introduction: In the last decade, there has been increased global policy and program momentum to promote early childhood development. The Care for Child Development (CCD) package, developed by UNICEF and the WHO, is a key tool responding to the global demand. The CCD package comprises two age-specific evidence-based recommendations for caregivers to 1) play and communicate and 2) responsively interact with their children (0-5 years) and was designed to be integrated within existing services to strengthen nurturing care for child development. The aim of this report was to provide an up-to-date global review of the implementation and evaluation of the CCD package. Methods: In addition to a systematic review of 55 reports, we interviewed 23 key informants (including UNICEF and WHO personnel) to better understand the implementation of CCD. Results: The CCD package has been or is being implemented in 54 low- and middle-income countries and territories, and it has been integrated into government services across the health, social, and education sectors in 26 countries. Across these contexts, CCD has been adapted in three primary ways: 1) translations of CCD materials (mostly counseling cards) into local language(s), 2) adaptations of CCD materials for the local context, vulnerable children, or a humanitarian/emergency setting (e.g., including local play activities, using activities that are better suited to children with visual impairments), and 3) substantive modifications to the content of CCD materials (e.g., expansion of play and communication activities, addition of new themes, creation of a structured curriculum). While there is promising evidence and examples of good implementation practice, there has been mixed experience about implementation of CCD with respect to adaptation, training, supervision, integration into existing services, and monitoring implementation fidelity and quality. For example, many users of CCD found difficulties with training the workforce, garnering buy-in from governments, and ensuring benefits for families, among others. Discussion: Additional knowledge on how to improve the effectiveness, implementation fidelity and quality, and acceptance of CCD is needed. Based on the findings of the review we make recommendations for future efforts to implement CCD at-scale.

Father involvement and early child development in a low-resource setting.

Evidence on the role of father involvement in children's development from low-resource settings is very limited and historically has only relied on maternal reports of father's direct engagement activities such as reading to the child. However, fathers can also potentially influence their children's development via greater positive involvement with the mother, such as by offering interpersonal support or sharing decision-making duties. Such positive intrahousehold interactions can benefit maternal mental health and wellbeing, and ultimately children's development. We use data collected from mothers, fathers and children in the context of the cluster randomized controlled trial evaluation of Msingi Bora, a responsive parenting intervention implemented across 60 villages in rural western Kenya, to explore the various pathways through which fathers may influence their children's outcomes. In an endline survey in Fall 2019 among a sample of 681 two-parent households with children aged 16-34 months, fathers reported on measures of their behaviors towards children and with mothers, mothers reported on their wellbeing and behaviors, and interviewers assessed child cognitive and language development with the Bayley Scales. In adjusted multivariate regression analyses we found that greater father interpersonal support to mothers and greater participation in shared household decision-making were positively associated with children's development. These associations were partially mediated through maternal wellbeing and behaviors. We found no association between fathers' direct engagement in stimulation activities with children and children's outcomes. Inviting fathers to the program had no impact on their involvement or on any maternal or child outcomes, and fathers attended sessions at low rates. Overall, our results show the potential promises and challenges of involving fathers in a parenting intervention in a rural low-resource setting. Our findings do highlight the importance of considering intrahousehold pathways of influence in the design of parenting interventions involving fathers.

TSH Mediated the Effect of Iodized Salt on Child Cognition in a Randomized Clinical Trial.

OBJECTIVES: This study examines the hormonal mediators of the effect of iodized salt in pregnancy on child cognition. METHODS: Sixty districts across 6 zones in the Amhara region of Ethiopia were randomly allocated to a control or intervention arm of early market access to iodized salt. Twenty-two villages per arm were randomly selected for this sub-study. A total of 1220 pregnant women who conceived after the intervention began were enrolled and assessed for their iodine and iron status. Data were collected once on the household socio-demographic status and iodized salt use, and maternal urinary iodine during pregnancy. Then, infants' diet, urinary iodine level, cognitive development (Bayley III), serum hormonal levels, iron status, and inflammation markers were measured between 2 and 13 months of age. RESULTS: The median maternal urinary iodine concentration was adequate and significantly higher in the intervention mothers than that of the controls (163 vs 121 µg/L, P < .0001). Intervention children compared to the control children had lower thyroid-stimulating hormone (TSH) (mean: 2.4 ± 1.0 µIU/mL vs 2.7 ± 1.0 µIU/mL, effect size = 0.18, P < .01) and thyroglobulin (Tg) (41.6 ± 1.0 ng/mL vs 45.1 ± 1.0 ng/mL, effect size = 0.14, P < .05). There was an interaction between the intervention and iron stores such that cognition was higher with iron (effect size = 0.28, 100 vs 94 IQ points). TSH was a partial mediator (12%) of the effect of the intervention on child cognition (Sobel z-score = 2.1 ± 0.06, P < .05). CONCLUSION: TSH partially mediated the effect of the iodized salt intervention on child cognition.

An Implementation Evaluation of A Group-Based Parenting Intervention to Promote Early Childhood Development in Rural Kenya.

Early childhood development (ECD) parenting interventions can improve child developmental outcomes in low-resource settings, but information about their implementation lags far behind evidence of their effectiveness, hindering their generalizability. This study presents results from an implementation evaluation of Msingi Bora ("Good Foundation" in Swahili), a group-based responsive stimulation and nutrition education intervention recently tested in a cluster randomized controlled trial across 60 villages in rural western Kenya. Msingi Bora successfully improved child cognitive, receptive language, and socioemotional outcomes, as well as parenting practices. We conducted a mixed methods implementation evaluation of the Msingi Bora trial between April 2018 and November 2019 following the Consolidated Advice for Reporting ECD implementation research (CARE) guidelines. We collected qualitative and quantitative data on program inputs, outputs, and outcomes, with a view to examining how aspects of the program's implementation, such as program acceptance and delivery fidelity, related to observed program impacts on parents and children. We found that study areas had initially very low levels of familiarity or knowledge of ECD among parents, community delivery agents, and even supervisory staff from our partner non-governmental organization (NGO). We increased training and supervision in response, and provided a structured manual to enable local delivery agents to successfully lead the sessions. There was a high level of parental compliance, with median attendance of 13 out of 16 fortnightly sessions over 8 months. For delivery agents, all measures of delivery performance and fidelity increased with program experience. Older, more knowledable delivery agents were associated with larger impacts on parental stimulation and child outcomes, and delivery agents with higher fidelity scores were also related to improved parenting practices. We conclude that a group-based parenting intervention delivered by local delivery agents can improve multiple child and parent outcomes. An upfront investment in training local trainers and delivery agents, and regular supervision of delivery of a manualized program, appear key to our documented success. Our results represent a promising avenue for scaling similar interventions in low-resource rural settings to serve families in need of ECD programming. This trial is registered at ClinicalTrials.gov, NCT03548558, June 7, 2018. https://clinicaltrials.gov/ct2/show/NCT03548558.

Group-based parenting interventions to promote child development in rural Kenya: a multi-arm, cluster-randomised community effectiveness trial.

BACKGROUND: Early childhood development (ECD) programmes can help address early disadvantages for the 43% of children younger than 5 years in low-income and middle-income countries who have compromised development. We aimed to test the effectiveness of two group-based delivery models for an integrated ECD responsive stimulation and nutrition education intervention using Kenya's network of community health volunteers. METHODS: We implemented a multi-arm, cluster-randomised community effectiveness trial in three rural subcounties across 60 villages (clusters) in western Kenya. Eligible participants were mothers or female primary caregivers aged 15 years or older with children aged 6-24 months at enrolment. If married or in established relationships, fathers or male caregivers aged 18 years or older were also eligible. Villages were randomly assigned (1:1:1) to one of three groups: group-only delivery with 16 fortnightly sessions; mixed delivery combining 12 group sessions with four home visits; and a comparison group. Villages in the intervention groups were randomly assigned (1:1) to invite or not invite fathers and male caregivers to participate. Households were surveyed at baseline and immediately post-intervention. Assessors were masked. Primary outcomes were child cognitive and language development (score on the Bayley Scales of Infant Development third edition), socioemotional development (score on the Wolke scale), and parental stimulation (Home Observation for Measurement of the Environment inventory). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT03548558. FINDINGS: Between Oct 1 and Nov 12, 2018, 1152 mother-child dyads were enrolled and randomly assigned (n=376 group-only intervention, n=400 mixed-delivery intervention, n=376 comparison group). At the 11-month endline survey (Aug 5-Oct 31, 2019), 1070 households were assessed for the primary outcomes (n=346 group only, n=373 mixed delivery, n=351 comparison). Children in group-only villages had higher cognitive (effect size 0·52 SD [95% CI 0·21-0·83]), receptive language (0·42 SD [0·08-0·77]), and socioemotional scores (0·23 SD [0·03-0·44]) than children in comparison villages at endline. Children in mixed-delivery villages had higher cognitive (0·34 SD [0·05-0·62]) and socioemotional scores (0·22 SD [0·05-0·38]) than children in comparison villages; there was no difference in language scores. Parental stimulation also improved for group-only (0·80 SD [0·49-1·11]) and mixed-delivery villages (0·77 SD [0·49-1·05]) compared with the villages in the comparison group. Including fathers in the intervention had no measurable effect on any of the primary outcomes. INTERPRETATION: Parenting interventions delivered by trained community health volunteers in mother-child groups can effectively promote child development in low-resource settings and have great potential for scalability. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health.

Pre-pregnancy iodized salt improved children's cognitive development in randomized trial in Ethiopia.

The overarching Ethiopia project examined the effects of early market introduction of iodized salt on the growth and mental development of young children. Sixty districts were randomly assigned to intervention (early market access to iodized salt) or control (later access through market forces), and one community per district was randomly chosen as the sampling unit. For this project, 22 of the districts were included. The participants were 1,220 pregnant women who conceived after the intervention began. When their children were 2 to 13 months old, field staff collected information on household sociodemographic status and iodized salt intake, child stimulation, maternal depression symptoms, children's diet, anthropometry, urinary iodine concentration (UIC), hemoglobin, and mental development scores (Bayley III scales). Fewer mothers prepartum (28% vs. 41%, p < .05) and their children (13% vs. 20%, p < .05) were iodine deficient (UIC <50 µg/L) in the intervention compared with the control group. The intervention children had higher cognitive scores (33.3 ± 0.3 vs. 32.6 ± 0.3; Δ = 0.6; 95% CI [0.0, 1.3]; d = 0.17; p = .01; 4 IQ points) than their controls. The other Bayley subscale scores did not differ from control children. The intervention group had a higher child stimulation (22.7 ± 0.2 vs. 22.1 ± 0.2; Δ = 0.5; 95% CI [0.02, 0.89]; d = 0.17; p = .01) but not growth indicators (weight-for-age z score, length-for-age z score, and weight-for-length z score: -1.1 ± 0.1 vs. -1.1 ± 0.1, -1.7 ± 0.1 vs. -1.7 ± 0.1; -0.2 ± 0.1 vs. -0.1 ± 0.1, respectively, all p > .05) compared with their controls. Iodized salt intake improved iodine status of both pregnant women and their children and also child cognitive development.

Adaptation of a mental development assessment tool for the evaluation of the long-term effect of a successful nutrition intervention in Ghana.

This study adapted a cognitive assessment tool to be used in evaluating nutrition interventions in developing countries and assessed its reliability and validity in Ghana. The tool was used to evaluate the long-term effect of the Enhancing Child Nutrition through Animal Source Food Management (ENAM) project. The former ENAM participants' children were contacted (now 13 to 15 years old). The items in the Wechsler Abbreviated Scale of Intelligence-II were adapted, pretested, refined, and pretested again. Cross-sectional data collection was conducted with former ENAM participants (60 interventions and 51 comparison families) in one of ENAM's three sites (the Guinea Savanna zone). Data on participants' socio-economic status and food insecurity were collected, along with their children's intellectual functioning, dietary intake, school attainment, anthropometry, and symptoms of depression. Alpha coefficient of the verbal subscale improved between the first and second pretest (from .34 to .80). After controlling for age, the intelligence scores of the children were associated with their grade (r = .35, p = .001) and academic performance (r = .26 to .33, p < .05). The verbal scale was associated with their anthropometry (r = .24 to .27, p < .05). The intervention children still recorded a better dietary diversity score than controls (6.8 vs 5.8, p = .0001); however, significance was lost after adjusting for confounders. There were no significant group differences in growth or intellectual functioning. The adapted Wechsler Abbreviated Scale of Intelligence-II tool performed well in evaluating adolescent intellectual functioning in rural Ghana, and there were no long-term effects of ENAM intervention on child growth and development.

Testing means to scale early childhood development interventions in rural Kenya: the Msingi Bora cluster randomized controlled trial study design and protocol.

BACKGROUND: Forty-three percent of children under five in low and middle-income countries (LMICs) experience compromised cognitive and psychosocial development. Early childhood development (ECD) interventions that promote parent-child psychosocial stimulation and nutrition activities can help remediate early disadvantages in child development and health outcomes, but are difficult to scale. Key questions are: 1) how to maximize the reach and cost-effectiveness of ECD interventions; 2) what pathways connect interventions to parental behavioral changes and child outcomes; and 3) how to sustain impacts long-term. METHODS: Msingi Bora ("good foundation" in Swahili) is a multi-arm cluster randomized controlled trial across 60 villages and 1200 households in rural Western Kenya that tests different, potentially cost-effective and scalable models to deliver an ECD intervention in biweekly sessions lasting 7 months. The curriculum integrates child psychosocial stimulation with hygiene and nutrition education. The multi-arm study will test the cost-effectiveness of two models of delivery: a group-based model versus a mixed model combining group sessions with personalized home visits. Households in a third study arm will serve as a control group. Each arm will have 20 villages and 400 households with a child aged 6-24 months at baseline. Primary outcomes are child cognitive and socioemotional development and home stimulation practices. In a 2 × 2 design among the 40 treatment villages, we will also test the role of including fathers in the intervention. We will estimate intention-to-treat and local average treatment effects, and examine mediating pathways using Mediation Analysis. One treatment arm will receive quarterly booster visits for 6 months following the end of the sessions. A follow-up survey 2 years after the end of the main intervention period will examine sustainability of outcomes and any spillover impacts onto younger siblings. Study protocols have been approved by the Maseno Ethics Review Committee (MUERC) in Kenya (00539/18) and by RAND's institutional review board. This study is funded by the National Institute for Child Health and Human Development (R01HD090045). DISCUSSION: Results can provide policymakers with rigorous evidence of how best to design ECD interventions in low-resource rural settings. TRIAL REGISTRATION: Clinical Trial NCT03548558 registered June 7, 2018 at clinicaltrials.gov; AEA-RCT registry AEARCTR-0002913.

Measuring the implementation of early childhood development programs.

In this paper we describe ways to measure variables of interest when evaluating the implementation of a program to improve early childhood development (ECD). The variables apply to programs delivered to parents in group sessions and home or clinic visits, as well as in early group care for children. Measurements for four categories of variables are included: training and assessment of delivery agents and supervisors; program features such as quality of delivery, reach, and dosage; recipients' acceptance and enactment; and stakeholders' engagement. Quantitative and qualitative methods are described, along with when measures might be taken throughout the processes of planning, preparing, and implementing. A few standard measures are available, along with others that researchers can select and modify according to their goals. Descriptions of measures include who might collect the information, from whom, and when, along with how information might be analyzed and findings used. By converging on a set of common methods to measure implementation variables, investigators can work toward improving programs, identifying gaps that impede the scalability and sustainability of programs, and, over time, ascertain program features that lead to successful outcomes.

State of the science on implementation research in early child development and future directions.

We summarize the state of the field of implementation research and practice for early child development and propose recommendations. First, conclusions are drawn regarding what is generally known about the implementation of early childhood development programs, based on papers and discussions leading to a published series on the topic. Second, recommendations for short-term activities emphasize the use of newly published guidelines for reporting data collection methods and results for implementation processes; knowledge of the guidelines and a menu of measures allows for planning ahead. Additional recommendations include careful documentation of early-stage implementation, such as adapting a program to a different context and assessing feasibility, as well as the process of sustaining and scaling up a program. Using existing implementation information by building on and improving past programs and translating them into policy are recommended. Longer term goals are to identify implementation characteristics of effective programs and determinants of these characteristics.

Reporting guidelines for implementation research on nurturing care interventions designed to promote early childhood development.

Meta-analyses of interventions such as parenting, stimulation, and early childhood education have reported consistent medium-to-high effect sizes on early childhood development (ECD) and early learning outcomes. However, few effective interventions promoting ECD have achieved scale. In order to increase the access to effective or high-quality services, greater focus on implementation research of interventions promoting ECD is necessary. In this paper, we describe the development of reporting guidelines for implementation research of nurturing care interventions designed to promote ECD following an expert consensus-building process. The goal of these guidelines is to support a transparent and standard reporting of implementation evidence on nurturing care interventions designed to promote early childhood development.

Introduction of iodised salt benefits infants' mental development in a community-based cluster-randomised effectiveness trial in Ethiopia.

The effectiveness of salt iodisation in improving the mental development of young children has not been assessed. We implemented a community-based cluster-randomised effectiveness trial in sixty randomly selected districts in the Amhara region of Ethiopia. We randomly allocated each district to treatment and randomly selected one of its villages. In parallel to national salt iodisation efforts, iodised salt was brought early into the markets of the thirty intervention villages before it became widely available in the thirty control villages 4-6 months later. The primary outcome was children's mental development scores on the Bayley Scales. This was an intention-to-treat analysis using mixed linear models adjusted for covariates and clusters. The trial was registered at ClinicalTrials.gov, NCT013496. We assessed 1835 infants aged 5-11 months at baseline. The same children (85 % of the sample) were re-assessed at 20-29 months when all villages had iodised salt. At endline, urinary iodine concentration was higher in children in the intervention group compared with those in the control group (median 228·0 v. 155·1 µg/l, P=0·001). The intervention group had higher scores compared with the control group on the Bayley composite score (raw scores:130·60 v. 128·51; standardised scores: 27·8 v. 26·9; d=0·13; 95 % CI 0·02, 0·23) and three of the four subscales: cognitive (53·27 v. 52·54, d=0·13; 95 % CI 0·03, 0·23), receptive language (20·71 v. 20·18, d=0·13; 95 % CI 0·03, 0·24) and fine motor (35·45 v. 34·94, d=0·15; 95 % CI 0·04, 0·25). The introduction of iodised salt contributes to children's higher urinary iodine concentration and mental development.

Child development in rural Ghana: Associations between cognitive/language milestones and indicators of nutrition and stimulation of children under two years of age.

OBJECTIVES: Two studies aimed to assess the provision of nutrition and psychosocial stimulation in the home and to examine associations between mental development and nutrition and stimulation using a validated measure of development milestones. METHODS: The first study consisted of secondary analyses on health and nutrition data from 1081 mother-child pairs (the children aged 0-12 months) and their households in Ghana's Eastern Region. For the second study, the Ghana Milestones Measure, consisting of items assessing cognitive and language development, was used to assess child development in a subsample (N = 330) of Study 1 participants one year later (children 10-24 months of age). This measure was mother-reported and had been validated in a separate community in Ghana. Correlation and linear regression analyses were used to analyze the data. RESULTS: Family assets and maternal education were identified as key factors of the family context. Both variables were positively associated with preventive health practices (r = 0.08 to 0.13, p < 0.0001 to 0.01), and dietary diversity (r = 0.15, p = 0.0001 to 0.0006), and negatively associated with maternal depressive symptoms (r = -0.19 to -0.12, p < 0.0001). Taller children had higher receptive (standardized beta = 0.16; p = 0.04) and expressive (0.21; 0.003) language, but not cognitive (0.15; 0.07) milestone scores, and psychosocial stimulation was positively associated with all three milestones (receptive = 0.13, p = 0.01; expressive = 0.21, p < 0.0001; and cognitive = 0.24, p < 0.0001). CONCLUSION: Our study provides the first validated measure of children's language and cognitive development in Ghana, finding associations with nutrition and stimulation. The Ghana Milestones Measure can be used to assess and help promote children's mental development.